[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dermatomyositis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dermatomyositis":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,31,0,25,[9,48,81,116,141,171,207,232,274,296,323,345,365,400,423,446,481,503,525,546,566,590,614,642,663],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"officialTitle":15,"acronym":4,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":25,"conditions":26,"keywords":30,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":38,"lastUpdatePostDateStruct":39,"startDateStruct":42,"completionDateStruct":4,"leadSponsor":44,"locationsCount":47},"100059503","adult-and-juvenile-myositis-100059503",false,"NCT00017914","Adult and Juvenile Myositis","Studies in the Natural History and Pathogenesis of Childhood-Onset and Adult-Onset Idiopathic Inflammatory Myopathies","* ELIGIBILITY CRITERIA:\n\nPatients with Myositis:\n\nInclusion Criteria:\n\nAll patients should have age range 2-100 years.\n\nAll Patients admitted to the study must satisfy at least one of the following criteria among item 1 (A or B or C) OR item 2 (A or B or C) AND item 3:\n\n1. Patient has documented evidence that he\u002Fshe meets criteria for an idiopathic inflammatory myopathy\n\n   A. Possible, probable or definite adult or juvenile polymyositis or dermatomyositis by Bohan and Peter criteria\n\n   B. Possible, probable or definite inclusion body myositis by Griggs and\u002For ENMC criteria\n\n   C. Has an idiopathic inflammatory myopathy that does not meet these criteria, including common or rarer forms of myositis such as cancer- associated, focal, orbital, eosinophilic myositis, macrophagic, proliferative, etc.\n2. Has one of the following conditions:\n\n2A. Have a disorder that is related to an idiopathic inflammatory myopathy, that may include:\n\n* Inflammatory and non-inflammatory myopathies:\n* Mimicking and related skin disorders:\n* Disorders of the complications of myositis (including interstitial lung disease, calcifying disorders, cardiomyopathies, etc.):\n* Overlapping autoimmune diseases that may be associated with myositis\n* Patients with muscle and\u002For skin inflammation and documented environmental exposures:\n* Patients with myositis or complications of myositis and suspected genetic disorders:\n* Patients with undifferentiated connective tissue disease\n* Patients with signs or symptoms of myositis (such as weakness, skin rashes, interstitial lung disease) or laboratory abnormalities (such as elevated CK or muscle biopsy with myopathic features) who do not have an established diagnosis of myositis for them to be evaluated to establish a diagnosis\n\n  3\\. Ability of patient or parent\u002Fguardian to give informed consent to all or part of the study after full information has been provided.\n\nExclusion Criteria:\n\n1. Patients \\\u003C2 years or \\>100 years will be excluded.\n2. Any conditions in which the drawing of the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.\n\nFor females of childbearing potential who are pregnant, they will be permitted to enroll, but would be excluded from radiographic procedures involving radiation or greater than minimal risk procedures, including obtaining biopsies.\n\nRelatives of Patients with Myositis:\n\nFor patients with at least one first-degree relative affected with IIIM, all available first-degree relatives (affected and unaffected) are eligible to participate in the genetics portion of the protocol. For patients in which two or more first degree relatives are affected with myositis, any available close relatives (affected or unaffected parents, siblings or children, as well as grandparents and grandchildren, or other close relatives, when available) are eligible to participate in the genetics portion of the protocol.\n\nInclusion criteria:\n\n1. First or more distant relative of a proband with myositis, for genetics studies.\n2. Ability of patient or parent\u002Fguardian to give informed consent to all or part of the study after full information has been provided.\n\nExclusion Criteria:\n\n1. Patients \\\u003C2 years or \\>100 years will be excluded.\n2. Any conditions in which the drawing of the amount of blood required or undergoing procedures needed for the study is not deemed medically appropriate by the treating physician or the principal investigator.\n3. Pregnancy (females of childbearing potential). Verbal confirmation they are not pregnant.\n\nHealthy Volunteers:\n\nInclusion Criteria:\n\n1. Healthy volunteer subjects for biomarker studies will be gender and age-matched (within 5 years) with a myositis patient, as reasonably close as possible.\n2. Volunteer is not related to a myositis patient who is enrolled in the study\n3. Volunteer is in good health, without a recognized systemic rheumatic disorder, autoimmune disease, immune medicated disease, or cancer, and is not taking any anti-inflammatory medicines, including nonsteroidal anti-inflammatory drugs (NSAIDS) or corticosteroids\n4. Volunteer or volunteer s parent\u002Fguardian could give assent\u002Finformed consent to all or part of the study after full information has been provided\n\nExclusion Criteria:\n\nIf Any \"Yes\" answer patient is not eligible for study\n\n1. Volunteer has undergone surgery or had a major trauma within the past 2 months\n2. Volunteer used anti-inflammatory medications within the past 8 weeks of enrollment, including not currently receiving nonsteroidal anti-inflammatory drugs or corticosteroids\n3. Volunteer has been diagnosed with a chronic infectious illness, inflammatory disease, malignancy, cardiac or pulmonary disease, muscle disorder, clotting disorder, metabolic disorder, systemic rheumatic or autoimmune disease, or immune-mediated disease\n4. Volunteer is pregnant (verbally screened for females of childbearing potential)\n5. Volunteer has a medical illness that in the judgement of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation\n6. Volunteer is cognitively impaired\n7. Volunteer and or the volunteer's parents\u002Flegal guardian is unable or unwilling to give informed consent\u002Fassent\n8. Volunteer has functional limitations\n9. Volunteer has joint or muscle problems\n\nIn IMAGE Survey participants must confirm in the survey that they have a medical diagnosis of myositis.\n\nNote that the following screening activities may be performed to determine subject eligibility:\n\n* Email, written, or telephone communications with prospective subjects\n* Review of existing medical records\n* Review of existing imaging studies\n* Review of existing photographs or videos\n* Review of existing pathology specimens\u002Freports from a specimen obtained for diagnostic purposes\n\nIf a participant is ineligible and willing, their contact information- including name, phone numbers, emails, best times to reach, and potential diagnosis- may be shared with other NIH investigators if the participant may be eligible to participate in those studies.",true,"ALL","2 Years","100 Years",{"count":22,"type":23},1200,"ESTIMATED","OBSERVATIONAL","This study will evaluate subjects with adult- and childhood-onset myositis to learn more about their cause and the immune system changes and medical problems associated with them. Myositis is an inflammatory muscle disease that can damage muscles and other organs, resulting in significant disability.\n\nChildren or adults with polymyositis or dermatomyositis or a related condition may be evaluated under this study. Healthy children or adults will also be enrolled as \"controls,\" for comparison of test results.\n\nAll patients will undergo a complete history (including completing some questionnaires) and physical examination, review of medical records, and blood and urine tests. Patients may then choose to participate in an additional 1- to 5-day evaluation, which will include some or all of the following diagnostic, treatment or research procedures:\n\n1. Standardized muscle strength testing, range of motion of joints and walking (gait) analysis by a physiotherapist; completion of a questionnaire regarding ability to perform daily tasks\n2. Skin assessment, possibly including photographs of lesions and a skin biopsy (removal of a small skin sample under local anesthetic)\n3. Magnetic resonance imaging (scans that use magnetic fields to visualize tissues) of leg muscles\n4. Swallowing studies, including a physical examination and questionnaire on swallowing ability, studies of tongue strength, and ultrasound imaging during swallowing, and possibly, a modified barium swallow\n5. Voice and speech assessment, possibly including computerized voice analysis and laryngoscopy-analysis of the larynx (voice box) using a small rigid scope with a camera placed in the mouth to view and record vocal cord function\n6. Pulmonary function tests (measurement of air moved into and out of the lungs, using a breathing machine) to evaluate lung function and, possibly, chest X-ray\n7. Electrocardiogram (measurement of the electrical activity of the heart) and, possibly, echocardiogram (ultrasound imaging of the heart)\n8. Endocrine evaluation\n9. Eye examination, in patients with vision loss or other eye symptoms\n10. Nutrition assessment to evaluate muscle mass and muscle wasting, including tape measurements or bioelectric impedance testing, a painless procedure in which wires are attached to the extremities with a sticky paste.\n11. Muscle ultrasound.\n12. Electromyography (record of the electrical activity of muscles)\n13. Muscle or skin biopsy (removal of a small piece of muscle tissue for microscopic examination)\n\nAll patients may have only a one-time evaluation or may return for one follow-up evaluations (either the 1-day or 3- to 5-day evaluation) over a 1-year period.\n\nHealthy children will undergo a medical history and brief physical examination; blood and urine tests; speech and swallowing studies including questionnaires and physical examination, tongue strength, and ultrasound study; and bioelectric impedance testing. Children 8 to 18 years old may also have exercise testing.",[27,28,29],"Dermatomyositis","Polymyositis","Inclusion Body Myositis",[31,32,33,34,35,36],"Adult and Pediatric Disease","Autoimmunity Pathogenesis","Disease Assessment","Genetic and Environmental Risk Factors","Myositis","Natural History","RECRUITING","2026-06-27",{"date":40,"type":41},"2026-06-30","ACTUAL",{"date":43,"type":41},"1995-06-07",{"name":45,"class":46},"National Institute of Environmental Health Sciences (NIEHS)","NIH",4,{"id":49,"slug":50,"hasResults":12,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":4,"eligibilityCriteria":54,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":4,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":71,"startDateStruct":73,"completionDateStruct":75,"leadSponsor":77,"locationsCount":80},"100630376","phase-2-emapalumab-mda5-rapidly-progressive-interstitial-lung-disease-rp-ild-study-100630376","NCT07486869","Emapalumab MDA5 Rapidly Progressive Interstitial Lung Disease (RP-ILD) Study","Emapalumab for the Treatment of Anti-MDA5 Antibody Positive Rapidly Progressive Interstitial Lung Disease","Inclusion Criteria:\n\n* Progressive interstitial lung disease as determined by at least 2\u002F4 of the following:\n\n  1. worsening respiratory symptoms;\n  2. worsening or new oxygen requirement;\n  3. worsening disease on CT chest;\n  4. worsening Forced Vital Capacity (FVC1) or Diffusing Capacity for Carbon Monoxide (DLCO) on pulmonary function tests\n* MDA5 antibodies present\n* Elevated ferritin above the upper limit of normal (ULN)\n* Participant at least 18 years old\n\nExclusion Criteria:\n\n* Active, untreated bacterial, mycobacterial or fungal infection\n* Active herpes zoster infection\n* Currently requiring extracorporeal membrane oxygenation (ECMO)\n* Participant refusal to participate in the study\n* Pregnant women\n* Prisoners","18 Years",{"count":57,"type":23},5,"INTERVENTIONAL",[60],"PHASE2","This is a proof of concept study to determine if Emapalumab appears effective for the treatment of anti-MDA5 antibody positive rapidly progressive interstitial lung disease (MDA5 RP-ILD). Emapalumab is a medication that is currently used for a severe problem with the immune system, called macrophage activation syndrome, and this disease shares some similar features with MDA5 RP-ILD.",[27,63,64,65,66,67,68],"Dermatomyositis Sine Myositis","Dermatomyositis With Myopathy","Dermatomyositis With Respiratory Involvement","Dermatomyositis With Organ Involvement","Interstitial Lung Disease","Interstitial Lung Disease Due to Connective Tissue Disease (Disorder)","NOT_YET_RECRUITING","2026-06-16",{"date":72,"type":41},"2026-06-18",{"date":74,"type":23},"2026-07",{"date":76,"type":23},"2027-05",{"name":78,"class":79},"University of Miami","OTHER",1,{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":86,"acronym":4,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":58,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":70,"lastUpdatePostDateStruct":107,"startDateStruct":109,"completionDateStruct":111,"leadSponsor":113,"locationsCount":115},"100348403","phase-1-testing-an-immunotherapy-anti-cancer-drug-nivolumab-for-advanced-cancers-in-patients-with-autoimmune-disorders-aim-nivo-100348403","NCT03816345","Testing an Immunotherapy Anti-cancer Drug, Nivolumab, for Advanced Cancers in Patients With Autoimmune Disorders, AIM-NIVO","A Phase Ib Study of Nivolumab in Patients With Autoimmune Disorders and Advanced Malignancies (AIM-NIVO)","Inclusion Criteria:\n\n* Patients can have either histologically confirmed malignancy that is radiologically evaluable and metastatic or unresectable, or have a malignancy for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting, as well as the neoadjuvant or perioperative setting in which such treatment is considered standard of care or has been approved. Eligible tumor types include solid tumors and malignancies in which there is known evidence of clinical activity for single agent PD-1 or PD-L1 antibodies. Nivolumab or other PD1\u002FPD-L1 inhibitors are FDA-approved for the treatment of melanoma, non-small cell lung cancer (NSCLC), Merkel cell cancer, bladder cancer, renal cell carcinoma (RCC), gastric cancer, hepatocellular carcinoma (HCC), cervical cancer, head and neck cancer, Hodgkin lymphoma (HL), metastatic small cell lung cancer (SCLC), and any solid tumor with microsatellite instability (MSI)-high status confirmed. Patients with HL are eligible but must follow standard response criteria. Additional tumor types may be eligible on a case by case basis upon discussion with principal investigator (PI)\n\n  * Patients enrolling on the trial for adjuvant use will be restricted to those with histology for which a PD-1\u002FPD-L1 inhibitor has been approved in the adjuvant setting including but not limited to NSCLC, melanoma, RCC, cervical cancer, and bladder cancer\n  * Patients enrolled on the study can receive Nivolumab with other FDA-approved combinations according to the FDA package insert, including, but not limited to ipilimumab, cabozantinib or chemotherapy\n* Patients who have previously received other forms of immunotherapy (high-dose \\[HD\\] IL-2, IFN, CTLA-4) are allowed. Patients must not have received cytokine immunotherapy for at least 4 weeks before nivolumab administration. Patients who have received prior anti-CTLA4 will be allowed and the washout period is 6 weeks\n* Age \\>= 18 years; children are excluded from this study but may be eligible for future pediatric phase 1 combination trials\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 2 (Karnofsky \\>= 60)\n* Life expectancy of greater than 12 weeks\n* Leukocytes \\>= 1,000\u002FmcL\n* Absolute neutrophil count \\>= 500\u002FmcL\n* Platelets \\>= 50,000\u002FmcL\n* Total bilirubin =\\\u003C 2 x institutional upper limit of normal (ULN)\n* Aspartate aminotransferase (AST) (serum glutamic-oxaloacetic transaminase \\[SGOT\\])\u002Falanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \\[SGPT\\]) =\\\u003C 5 x institutional ULN or =\\\u003C 8 x institutional ULN for patients with liver metastases or an autoimmune disease that is contributing to the elevation of these values\n* Creatinine ULN OR glomerular filtration rate (GFR) \\>= 30 mL\u002Fmin (if using the Cockcroft-Gault formula)\n* Human immunodeficiency virus (HIV)-infected patients on effective antiretroviral therapy with undetectable viral load within 6 months are eligible for this trial\n* If evidence of chronic hepatitis B virus (HBV) infection, HBV viral load must be undetectable on suppressive therapy if indicated\n* If history of hepatitis C virus (HCV) infection, must be treated with undetectable HCV viral load\n* Patients with new or progressive brain metastases (active brain metastases) or leptomeningeal disease are eligible if the treating physician determines that immediate central nervous system (CNS) specific treatment is not required and is unlikely to be required for at least 4 weeks (or scheduled assessment after the first cycle of treatment), and a risk-benefit analysis (discussion) by the patient and the investigator favors participation in the clinical trial\n* The effects of nivolumab on the developing human fetus are unknown. For this reason, women of child-bearing potential (WOCBP) and men must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation. WOCBP receiving nivolumab will be instructed to adhere to contraception for a period of 5 months after the last dose of investigational product. Men receiving nivolumab and who are sexually active with WOCBP will be instructed to adhere to contraception for a period of 7 months after the last dose of investigational product\n\n  * Women of childbearing potential must have a negative serum or urine pregnancy test (minimum sensitivity 25 IU\u002FL or equivalent units of human chorionic gonadotropin \\[HCG\\]) within 24 hours prior to the start of nivolumab. Women must not be breastfeeding. Women who are not of childbearing potential (i.e., who are postmenopausal or surgically sterile as well as azoospermic men) do not require contraception\n  * WOCBP is defined as any female who has experienced menarche and who has not undergone surgical sterilization (hysterectomy or bilateral oophorectomy), tubal ligation, or who is not postmenopausal. Menopause is defined clinically as 12 months of amenorrhea in a woman over 45 in the absence of other biological or physiological causes. In addition, women under the age of 55 must have a documented serum follicle stimulating hormone (FSH) level less than 40 mIU\u002FmL\n  * These durations have been calculated using the upper limit of the half-life for nivolumab (25 days) and are based on the protocol requirement that WOCBP use contraception for 5 half-lives plus 30 days, and men who are sexually active with WOCBP use contraception for 5 half-lives plus 90 days\n  * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she (or the participating partner) should inform the treating physician immediately. Patients can resume treatment upon termination of a pregnancy or the completion of a successful pregnancy\n* Ability to understand and the willingness to sign a written informed consent document\n* Patients with more than one autoimmune disease are eligible. The treating physician would determine which autoimmune disease is dominant and the patient would be treated under that specific cohort (Please note: Patients with more than one autoimmune disease should receive assessments for all previously diagnosed autoimmune diseases. For example, a patient with psoriasis and IBD might be enrolled in the IBD cohort. Disease assessments for both psoriasis and IBD should be obtained, as per protocol. Case report forms \\[CRFs\\] for all relevant autoimmune diseases should be utilized. However, all additional cohort requirements will be considered optional and only the assessments from the assigned cohort will be considered mandatory)\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients with known SSc or DM according to updated classification criteria (Van den Hoogan et al., Arthritis Rheum 2013;65(11):2737-47; Lundberg et al., A\\&R in press). Overlap features are permitted, but patients must meet criteria for a \"primary diagnosis\" of DM or SSc\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for DM or SSc unless specifically excluded\n* DM\u002FSSc-SPECIFIC INCLUSION: Patients must have a baseline computed tomography (CT) of the chest (within 6 months of study entry)\n* RA-SPECIFIC INCLUSION: Rheumatologist-diagnosed RA requiring prior treatment with disease-modifying antirheumatic drugs (DMARDs) before patient was diagnosed with current malignancy. We recommend, but do not require, documentation for meeting 2010 American College of Rheumatology (ACR)\u002FEuropean League Against Rheumatism (EULAR) classification criteria for RA\n* RA-SPECIFIC INCLUSION: Prednisone up to 10 mg\u002Fday will be allowed. Intraarticular steroids will be allowed for the treatment of new symptomatic joints\n* RA-SPECIFIC INCLUSION: Nonsteroidal anti-inflammatory drugs (NSAIDs) will be allowed\n* SLE-SPECIFIC INCLUSION: SLE diagnosed by a rheumatologist. The patient should meet the revised 1997 American College of Rheumatology (ACR) classification criteria for SLE, but this is not mandatory\n* ULCERATIVE COLITIS (UC)-SPECIFIC INCLUSION: Diagnosis of UC must be made by endoscopy with biopsies\n* UC-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* UC-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (antigen \\[Ag\\] negative, antibody \\[core (c)Ab\\] negative, antibody \\[surface (s)Ab\\] positive or negative) and Mycobacterium tuberculosis (purified-protein- derivative \\[PPD\\] or enzyme-linked immunospot assay \\[ELISpot or T-spot\\]) or be on appropriate anti-microbial treatment for these infections\n* UC-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission, defined as a Mayo Clinic score (MCS) of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 either without medications, or treated with 5-ASA derivative, probiotic, or prior fecal transplant\n* UC-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on 6-mercaptopurine, azathioprine, methotrexate, or rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* UC-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either be A) in clinical remission, defined as a MCS of 2 or lower and no subscore higher than 1, and an endoscopic subscore of 0 or 1 on a biologic therapy targeting tumor necrosis alpha (TNF-α) (infliximab, adalimumab, golimumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease defined as a MCS of 3-5 and no subscore higher than 2, and an endoscopic subscore of \\\u003C 2 on one of the medications or combination of medications defined for the Moderate or Mild cohort\n* CROHN'S DISEASE (CD)-SPECIFIC INCLUSION: Complete colonoscopy with biopsies during study screening, within 8 weeks before initial nivolumab administration, or within 4 weeks after initial nivolumab administration\n* CD-SPECIFIC INCLUSION: If patients have prior known disease in the stomach or small intestines, appropriate endoscopic evaluation (esophagogastroduodenoscopy\u002Fvideo capsule endoscopy) and\u002For imaging (computed tomography or magnetic resonance enterography) must also be current within 4 weeks prior to nivolumab administration\n* CD-SPECIFIC INCLUSION: Deep enteroscopy techniques, such as double balloon enteroscopy, will not be required\n* CD-SPECIFIC INCLUSION: Patients must test negative for hepatitis B (sAg negative, cAb negative, sAb positive or negative) and M. tuberculosis (PPD or ELISpot or T-spot) or be on appropriate anti-microbial treatment for these infections\n* CD-SPECIFIC INCLUSION: Mild Disease Cohort: Patients must be in clinical remission as defined by a Crohn's Disease Activity Index (CDAI) \\\u003C 150 either without treatment or on a 5-ASA derivative, probiotic, antibiotics, or following fecal transplant\n* CD-SPECIFIC INCLUSION: Moderate Disease Cohort: Patients must be in clinical remission as defined by a CDAI \\\u003C 150 on 6-mercaptopurine, azathioprine, methotrexate, rectal hydrocortisone, budesonide, or one of these medications in combination with any of the medications listed in the Mild cohort\n* CD-SPECIFIC INCLUSION: Severe Disease Cohort (A or B): Patients must either A) be in clinical remission as defined by a CDAI \\\u003C 150 on biologic therapy targeting TNF-α (infliximab, adalimumab, certolizumab pegol), IL-12\u002F23p40 (ustekinumab), α4β7 integrin (vedolizumab), or one of these biologic therapies in combination with any of the medications listed in the Mild or Moderate cohort, or B) have mild active disease as defined by a CDAI of 150 to 220 on one of medications or combination of medications defined for the Moderate or Mild cohort\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For other autoimmune diseases that cannot be classified, the eligibility criteria will be determined by the managing rheumatologist or other autoimmune disease specialist, based on the clinical judgement and current American College of Radiology (ACR) classification guidelines or other relevant guidelines, as per the disease category in question\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For giant cell arteritis (GCA), patients must have had positive temporal artery biopsy for GCA and abnormal erythrocyte sedimentation rate (ESR) at time of diagnosis\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: For polymyalgia rheumatica (PMR), patients must have clinical diagnosis in addition to elevated inflammatory markers including (ESR, C reactive protein \\[CRP\\])\n* OTHER AUTOIMMUNE DISEASES- NS-SPECIFIC INCLUSION: Patients can be in remission (with no glucocorticoids or immunosuppressive medications) or have low-moderate activity, which is defined as being on prednisone ≤ 10 mg or equivalent\n* MS-SPECIFIC INCLUSION: Patients must meet 2017 McDonald criteria for the diagnosis of MS (Thompson AJ, et al. Diagnosis of multiple sclerosis: 2017 revision of the McDonald criteria. Lancet Neurol. 17(2):162-173.)\n* MS-SPECIFIC INCLUSION: Patients with MS can be in remission and can have a history of being on immunomodulatory agents, but at the time of entry into the clinical trial, patients should be off any concurrent MS therapy for at least 2 weeks. Patients receiving concomitant interferon gamma (IFN-γ treatment) will be permitted in the study\n* SJS-SPECIFIC INCLUSION: SjS diagnosed by a rheumatologist or oral medicine provider. The patient should meet the American-European Consensus Criteria for Sjögren's Syndrome (Vitali, et al., 2002). If on treatment, the patient may only be on hydroxychloroquine and prednisone ≤ 10 mg or equivalent\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients with known PsO as diagnosed by a dermatologist or PsA by a rheumatologist and\u002For by Classification for Psoriatic Arthritis (CASPAR) criteria (Tillett et al., 2012)\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients must have stable disease as determined by the investigator with no change in systemic therapy and\u002For biologic therapy for at least 3 months, except for those on tumor necrosis factor (TNF) inhibitors. In the case of TNF inhibition, patients may have transitioned to an alternative biologic therapy with stable disease for at least 4 weeks. For PsA, no change in corticosteroid therapy for at least 1 month prior to baseline and dose must be 10 mg or less\n* PSO\u002FPSA-SPECIFIC INCLUSION: Patients may be on any concurrent therapy for PsO or PsA unless specifically excluded\n\nExclusion Criteria:\n\n* Patients who have had chemotherapy or radiotherapy within 2 weeks (6 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events (AEs) due to agents administered more than 4 weeks earlier have not resolved or stabilized. Palliative (limited-field) radiation therapy (RT) is permitted (2 week washout from start of treatment), if all of the following criteria are met:\n\n  * Repeat imaging demonstrates no new sites of bone metastases\n  * The lesion being considered for palliative radiation is not a target lesion\n* Patients with prior therapy with an anti-PD-1 or anti-PD-L1\n* Patients with prior allogeneic hematologic transplant\n* Patients who are receiving any other anticancer investigational agents\n* Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness\u002Fsocial situations that would limit compliance with study requirements\n* UC-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* UC-SPECIFIC EXCLUSION: Prior colectomy\n* UC-SPECIFIC EXCLUSION: Concurrent primary sclerosing cholangitis (PSC). Patients with PSC can be enrolled on the Other Autoimmune Diseases Cohorts\n* UC-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* CD-SPECIFIC EXCLUSION: Known untreated abscesses, untreated and symptomatic strictures, short gut physiology, or isolated jejunal disease\n* CD-SPECIFIC EXCLUSION: Patients who have received ipilimumab treatment\n* CD-SPECIFIC EXCLUSION: Patients on empiric immunosuppressive treatment without any clinical workup\n* MS-SPECIFIC EXCLUSION: Patients with MS cannot have medical contraindications to gadolinium-enhanced magnetic resonance imaging (MRI)",{"count":89,"type":23},300,[91],"PHASE1","This phase Ib trial studies the side effects of nivolumab and to see how well it works alone and in combination with other treatments, such as ipilimumab, cabozantinib, platinum containing therapy, and fluoropyrimidine, in treating patients with autoimmune disorders and cancer that has spread from where it first started (primary site) to nearby tissue, lymph nodes, or distant parts of the body (advanced), to other places in the body (metastatic) or cannot removed by surgery (unresectable). Immunotherapy with monoclonal antibodies, such as nivolumab and ipilimumab, may help the body's immune system attack the cancer, and may interfere with the ability of tumor cells to grow and spread. Cabozantinib blocks certain proteins, which may help keep tumor cells from growing. It may also prevent the growth of new blood vessels that tumors need to grow. Cabozantinib is a type of tyrosine kinase inhibitor and a type of angiogenesis inhibitor. Chemotherapy drugs, such as platinum containing therapies and fluoropyrimidine, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Giving nivolumab alone and in combination with other treatments, including ipilimumab, cabozantinib, platinum containing therapy, or fluoropyrimidine, may be safe, tolerable, and\u002For effective in treating patients with autoimmune disorders and advanced, metastatic, or unresectable cancer.",[94,95,27,96,97,98,99,100,101,102,103,104,105,106],"Autoimmune Disease","Crohn Disease","Hematopoietic and Lymphoid Cell Neoplasm","Inflammatory Bowel Disease","Malignant Solid Neoplasm","Multiple Sclerosis","Psoriasis","Psoriatic Arthritis","Rheumatoid Arthritis","Sjogren Syndrome","Systemic Lupus Erythematosus","Systemic Scleroderma","Ulcerative Colitis",{"date":108,"type":41},"2026-06-17",{"date":110,"type":41},"2019-07-16",{"date":112,"type":23},"2028-03-30",{"name":114,"class":46},"National Cancer Institute (NCI)",52,{"id":117,"slug":118,"hasResults":12,"nctId":119,"briefTitle":120,"officialTitle":121,"acronym":4,"eligibilityCriteria":122,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":123,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":137,"completionDateStruct":4,"leadSponsor":139,"locationsCount":140},"100153996","environmental-risk-factors-for-the-anti-synthetase-syndrome-100153996","NCT01276470","Environmental Risk Factors for the Anti-synthetase Syndrome","Environmental Risk Factors for the Anti-Synthetase Syndrome","* INCLUSION CRITERIA:\n\nThere are no gender or ethnic restrictions to enrollment in the study. Age restrictions for children do apply to enrollment in the study.\n\nThe inclusion criteria for enrollment of myositis subjects are:\n\n1. Diagnosis of myositis based on criteria for possible, probable or definite PM or DM, with or without other connective tissue diseases, documented within 24 months of enrollment (using the most recent diagnosis date to define the 24-month period).\n2. CXR to assess possible ILD and assign the subject to the presumptive anti-synthetase positive or negative category if clinically indicated.\n3. Children must be greater than two years of age.\n4. Able and willing to give informed consent, to complete the questionnaires and to donate blood samples (in case of children greater than 2 years of age but \\\u003C18 years of age, parent\u002Flegal guardian must be willing and able to provide informed consent and child will provide assent according to child s maturity level and understanding).\n\nThe exclusion criteria for myositis subjects are:\n\n1. Cancer-associated myositis (cancer diagnosed within 2 years of the diagnosis of myositis).\n2. Inclusion body myositis.\n3. Myositis that has clearly developed as the result of a drug, toxin or other exposure and has resolved after discontinuation of the exposure to that agent.\n4. Children less than 2 years of age.\n\nThe inclusion criteria for controls are:\n\n1. Friends or, if friends are not available, cousins of the anti-synthetase-positive myositis patient, or, if friends or cousins are not available, volunteers from the general community (such as the NIH Normal volunteer program), race- gender- and age- (within 5 years for minors and within 10 years for adults) matched, and when possible who is living as close as possible to the geographic area of the myositis patient.\n2. Controls should be without a recognized autoimmune disease or ILD.\n3. Able and willing to give informed consent, to complete the questionnaires and to donate blood samples (in case of children greater than 2 years of age but \\\u003C18 years of age, parent\u002Flegal guardian must be willing and able to provide informed consent) and child will provide assent according to child maturity level and understanding).\n\nThe exclusion criteria for all protocol subjects are:\n\n1. Medical illness that in the judgment of the investigators does not allow safe blood draws or other clinical evaluations needed for study participation.\n2. Cognitive impairment.\n3. Not able or willing to give informed assent or consent.\n4. Children less than 2 years of age.\n5. Patients who at their reference date were not in the US or Canada\n6. Individuals currently incarcerated\n\nHIV considerations:\n\nHIV is not an exclusion for affected participants in this study for the two following reasons:\n\n1. It has no impact on study procedures or tests.\n2. It may be one of the viral risk factors we are investigating.",{"count":124,"type":23},580,"Background:\n\n* Like other complex diseases, autoimmune diseases are the result of numerous causes, including genetic and environmental factors. Some researchers believe that people who are susceptible to autoimmune disorders develop them when the body reacts to environmental or other factors by creating white blood cells that attack the body s own tissues, which then progresses to autoimmune diseases. These immune-triggered disorders can overlap with one another to some extent, but most autoimmune diseases have certain distinct triggers.\n* The autoimmune disorder myositis weakens the muscles and may cause other health problems. Environmental exposures associated with myositis include ultraviolet radiation, stressful life events and muscle overexertion, collagen implants, infections such as retroviruses and streptococci bacteria, and certain drugs and chemicals. Some individuals with myositis also produce proteins in the blood called autoantibodies that react with certain parts of the person s own cells, called synthetases, which are involved in making new proteins. A syndrome called the anti-synthetase syndrome, which includes myositis and lung disease, is associated with having the anti-synthetase autoantibodies. Researchers are interested in studying differences in environmental exposures in individuals with myositis. This study is being conducted to determine if persons with the anti-synthetase syndrome have had different environmental exposures before disease onset compared with other patients with myositis who do not have this syndrome and also compared with healthy volunteers.\n\nObjectives:\n\n\\- To determine whether selected infectious and noninfectious environmental exposures are more common in individuals who have myositis with the anti-synthetase syndrome, compared with healthy volunteers.\n\nEligibility:\n\n\\- Individuals who have been diagnosed with myositis (with or without anti-synthetase autoantibodies), and healthy volunteers without autoimmune disorders.\n\nDesign:\n\n* Participants will be screened with a full medical history and physical examination, and will provide blood, urine and house dust samples.\n* Participants will complete questionnaires about their medical history and the types of exposures they have had at work, at home, and elsewhere. Participants who have myositis will also be asked about certain infections, heavy exercise or physical exertion, sun exposure, tobacco and alcohol use, and stressful events prior to being diagnosed with the disease. Healthy volunteers will be asked about the same exposures before the date of diagnosis of disease of the myositis subject to which they have been matched.\n* Participants will receive a kit that contains instructions and a filter to be put onto their vacuum cleaner to collect house dust in the bedroom. This dust will be kept for possible future analyses of infectious or toxic agents based on the other results from the study.\n* Individuals with myositis will have other tests as clinically indicated, including lung function tests and imaging studies.",[35,27,28,127,128],"Juvenile Dermatomyositis","Juvenile Polymyositis",[130,131,132,32,133,36],"Adult and Pediatric Autoimmune Disease","Antibody","Autoimmune Diseases","Environmental Risk Factors","2026-06-11",{"date":136,"type":41},"2026-06-12",{"date":138,"type":41},"2011-02-09",{"name":45,"class":46},8,{"id":142,"slug":143,"hasResults":12,"nctId":144,"briefTitle":145,"officialTitle":146,"acronym":147,"eligibilityCriteria":148,"healthyVolunteers":17,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":149,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":151,"conditions":152,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":163,"lastUpdatePostDateStruct":164,"startDateStruct":165,"completionDateStruct":167,"leadSponsor":169,"locationsCount":80},"100562149","identification-of-cutaneous-and-blood-biomarkers-predictive-of-response-to-systemic-treatments-during-chronic-inflammatory-skin-diseases-100562149","NCT06599411","Identification of Cutaneous and Blood Biomarkers Predictive of Response to Systemic Treatments During Chronic Inflammatory Skin Diseases","Identification Des Marqueurs Biologiques cutanés et Sanguins prédictifs de réponse Aux Traitements systémiques au Cours Des Maladies cutanées Inflammatoires Chroniques","ImmuneSkinBank","Inclusion Criteria:\n\nPatients:\n\n* Age\\>18 years\n* Informed consent signed by the patient\n* Diagnosis of moderate to severe chronic inflammatory skin disease (IGA score 3 or 4) including: atopic dermatitis, psoriasis, hidradenitis suppurativa, lichen planus, cutaneous lupus, dermatomyositis, cutaneous scleroderma (=morphea), neutrophilic dermatosis, cutaneous granulomatosis, cutaneaous vasculitis, autoimmune bullous dermatosis\n* Or diagnosis of active leprosy (tuberculoid, lepromatous, reversion type 1, reversion type 2, hypersensitivity type 3), excluding pure neurological leprosy. Classification into 5 stages according to the Ridley and Jopling classification \\[1\\], Reversion reaction (type 1 reaction) and leprous erythema nodosum (type 2 reaction).\n\nHealthy controls :\n\n* Age\\>18 years\n* Plastic surgery patients who have had any type of surgery resulting in healthy skin remnants\n* Informed consent signed by the patient\n* Absence of known cutaneous inflammatory disease.\n\nExclusion Criteria:\n\n* Under guardianship or curatorship\n* Pregnant or breastfeeding woman\n* Lack of affiliation with a social security system\n* Current systemic treatment with immunosupressant (including corticosteroid therapy) or an immunomodulator or received within the last 3 months.",{"count":150,"type":23},830,"Chronic inflammatory skin diseases constitute a heterogeneous group of pathologies. They affect the skin but also other organs (joints, lungs, muscles, etc.). Their prognosis and response to treatments is extremely variable. The discovery of prognosis factors will help to precisely guide the treatment regimen and its intensification based on individual markers. The identification of new therapeutic targets is essential to develop new innovative treatments for inflammatory skin diseases.\n\nThe main objective is to identify new cellular or molecular prognostic factors associated with treatment response at 1 year in inflammatory skin diseases.\n\nThe secondary objectives are a better understanding of the pathophysiology of chronic inflammatory skin diseases, the identification of new cellular, molecular and microbiological prognostic factors associated with the clinical state after 10 years of evolution and the identification of prognostic markers of drug toxicity.",[153,100,154,155,156,27,157,158,159,160,161,162],"Atopic Dermatitis","Hidradenitis Suppurativa","Lichen Planus","Cutaneous Lupus","Cutaneaous Scleroderma","Neutrophilic Dermatosis","Cutaneous Granulomatosis","Active Leprosy","Autoimmune Bullous Dermatosis","Cutaneous Vasculitis","2026-06-10",{"date":136,"type":41},{"date":166,"type":41},"2025-10-20",{"date":168,"type":23},"2045-10-20",{"name":170,"class":79},"Assistance Publique - Hôpitaux de Paris",{"id":172,"slug":173,"hasResults":12,"nctId":174,"briefTitle":175,"officialTitle":176,"acronym":4,"eligibilityCriteria":177,"healthyVolunteers":12,"sex":18,"minAge":178,"maxAge":179,"enrollmentInfo":180,"targetDuration":4,"studyType":58,"phases":182,"briefSummary":184,"conditions":185,"keywords":191,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":197,"lastUpdatePostDateStruct":198,"startDateStruct":199,"completionDateStruct":201,"leadSponsor":203,"locationsCount":206},"100527937","phase-2-reset-myositis-an-open-label-study-to-evaluate-the-safety-and-efficacy-of-caba-201-in-subjects-with-active-idiopathic-inflammatory-myopathy-or-juvenile-idiopathic-inflammatory-myopathy-100527937","NCT06154252","RESET-Myositis: An Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy","A Phase 1\u002F2, Open-Label Study to Evaluate the Safety and Efficacy of Autologous CD19-specific Chimeric Antigen Receptor T Cells (CABA-201) in Subjects With Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy","Adult Cohorts\n\nInclusion Criteria:\n\n* Age ≥18 and ≤75\n* A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism\u002FAmerican College of Rheumatology classification criteria\n* Diagnosis of DM, ASyS, or IMNM\n* Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated creatine kinase (CK), DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography\n* Presence of muscle weakness\n\nOther protocol-defined criteria apply.\n\nExclusion Criteria:\n\n* Contraindication to leukapheresis\n* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites\n* Active infection requiring medical intervention at screening\n* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections\n* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures\n* Significant lung or cardiac impairment\n* Previous CAR T cell therapy\n* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant\n\nOther protocol-defined criteria apply.\n\nJuvenile Cohort\n\nInclusion Criteria:\n\n* Age ≥6 and ≤17 years at enrollment\n* A clinical diagnosis of IIM, based on the 2017 The European League Against Rheumatism\u002FAmerican College of Rheumatology classification criteria\n* Evidence of active disease, despite prior or current treatment with standard of care treatments, as defined by the presence of elevated muscle enzymes, DM rash, or active disease on muscle biopsy, magnetic resonance imaging (MRI), or electromyography\n\nOther protocol-defined criteria apply.\n\nExclusion Criteria:\n\n* Contraindication to leukapheresis\n* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites\n* Active infection requiring medical intervention at screening\n* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.\n* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures\n* Significant lung or cardiac impairment\n* Previous CAR T cell therapy\n* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant\n\nOther protocol-defined criteria apply.","6 Years","75 Years",{"count":181,"type":23},74,[60,183],"PHASE3","RESET-Myositis: Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Subjects with Active Idiopathic Inflammatory Myopathy or Juvenile Idiopathic Inflammatory Myopathy",[186,27,187,188,127,128,189,190],"Idiopathic Inflammatory Myopathy","Anti-Synthetase Syndrome","Immune-Mediated Necrotizing Myopathy","Juvenile Idiopathic Inflammatory Myopathy (JIIM)","Juvenile Myositis",[192,94,193,194,186,35,27,195,196,127,128,189,190],"CABA-201","Anti-CD19 CAR-T therapy","Cellular Therapy","Anti-synthetase Syndrome","Immune-mediated Necrotizing Myopathy","2026-06-08",{"date":163,"type":41},{"date":200,"type":41},"2023-12-20",{"date":202,"type":23},"2028-07",{"name":204,"class":205},"Cabaletta Bio","INDUSTRY",35,{"id":208,"slug":209,"hasResults":12,"nctId":210,"briefTitle":211,"officialTitle":212,"acronym":213,"eligibilityCriteria":214,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":215,"enrollmentInfo":216,"targetDuration":4,"studyType":58,"phases":218,"briefSummary":219,"conditions":220,"keywords":221,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":224,"lastUpdatePostDateStruct":225,"startDateStruct":227,"completionDateStruct":229,"leadSponsor":231,"locationsCount":80},"100437168","phase-3-baricitinib-in-patients-with-relapsing-or-nave-dermatomyositis-100437168","NCT04972760","Baricitinib in Patients With Relapsing or naïve Dermatomyositis","Baricitinib in Patients With Relapsing or naïve Dermatomyositis: a Multicenter Randomized Controlled Trial (BIRD)","BIRD","Inclusion Criteria:\n\n* Adult subjects (≥ 18 years old) \\\u003C 65 years old\n* Dermatomyositis defined according to the 239th ENMC criteria either naïve or non-naïve DM\n* Active disease (ACR\u002FEULAR criteria) defined as :\n\n  * Manual Muscle Testing (MMT-8) \\\u003C145\u002F150 and at least two additional abnormal corset measurements (CSM): \\>3\u002F10 cm on Visual Analogue Scale (VAS) of patient global, physician global and extra-muscular disease activity, Health Assessment Questionnaire Disability Index \\>0.25, or elevated muscle enzymes.\n  * Or cutaneous CDASI \\> 20 and at least two additional abnormal corset measurements (CSM): \\>3\u002F10 cm on Visual Analogue Scale (VAS) of patient global, physician global and extra-muscular disease activity, Health Assessment Questionnaire Disability Index \\>0.25, or elevated muscle enzymes\n* for relapsing\u002Fnon naïve DM patients :\n\n  * in case of corticosteroid exposure patient must receive a stable dose \\\u003C 30 mg\u002Fd prednisone with or without additional immunosuppressive therapy for at least 4 weeks before the baseline visit.\n  * Stable dose of immunosuppressive therapy for at least 3 months before\n* Affiliation to a social security regime\n* Written informed consent\n\nExclusion Criteria:\n\n* Life-threatening complications :\n\n  * Severe swallowing troubles defined as: food swallowed the wrong way and\u002For time to drink a glass of 200 ml water above 30 seconds related to DM.\n  * Interstitial lung disease related to the DM with one among the following complications (complications must be related to the ILD): dyspnea NYHA III, hypoxemia with PaO2≤65 mmHg, and\u002For DLCOc\u002FAlveolar Volume ≤70% (pulmonary function test)\n  * Symptomatic myocarditis o Loss of walking ability\n* Patient with deep vein thrombosis\u002Fpulmonary embolism or antecedent\n* Patient with antecedent of cardiovascular event (myocardial infarction or ischemic stroke)\n* Patient who is current or past long-time smoker\n* Pregnant or lactating, or women planning to become pregnant or initiating breastfeeding\n* No effective contraception during the study and one week after for women of childbearing age\n* Renal impairment defined as clearance \\\u003C 60 ml\n* Strong Organic Anion Transporter 3 (OAT3) inhibitors\n* Active cancer or history of malignancy\n* Active severe infection including active hepatitis\n* Evidence of latent tuberculosis (as documented by a positive QuantiFERON-TB Gold plus test)\n* Absolute Neutrophil Count \\\u003C 1x109 cells\u002FL\n* Haemoglobin (Hb) \\\u003C 8 g\u002FdL\n* Severe hepatic impairment attested by FV (coagulation factor)\\\u003C30%\n* Liver insufficiency (Prothrombin time \\\u003C60%)\n* Previous treatment exposure defined as follow : • Rituximab treatment within 6months before inclusion\n\n  * IVIg, or cyclophosphamide infusion within the month before inclusion\n  * both methotrexate (0.3 mg\u002Fkg\u002Fw) and azathioprine exposure for at least 3 months each and at the 0.3 mg\u002Fkg\u002Fw and 2-3 mg\u002Fkg\u002Fd dosages respectively with failure of both (but exposure and\u002For failure to either of these two drugs alone is not an exclusion criterion)\n  * for naïve DM patients only, more than 2 weeks treatment duration with corticosteroids at the dose of 1 mg\u002Fkg\u002Fd before the inclusion.\n* Hypersensitivity to the active substance (baricitinib) or to any of the excipients\n* Contraindication to Methotrexate and\u002For Azathioprine including hypersensitivity to the active substances or to any of the excipients\n* Conditions affecting the outcomes (Expected poor compliance)\n* Severe disease damages: e.g. muscle weakness mainly related to muscle damage such as fat replacement of muscle) defined as persistent changes in anatomy, physiology, pathology or function which result from previously active disease and from complications of therapy or other events (e.g.; muscle atrophy, fatty replacement; skin scars, poikiloderma ). Severe disease damage is considered when the patient condition has no or minor ability to improve with the treatment.\n* Significant uncontrolled cardiovascular, cerebrovascular, respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, or neuropsychiatric disorders, or abnormal laboratory values that developed during a qualifying study that, in the opinion of the investigator, poses an unacceptable risk for the patient's participation\n* Chest imaging (CT scan or radiograph) showing abnormalities not related with the DM in the last 12 weeks judged by the investigator as clinically significant.\n* Participants included in other intervention research involving humans\n* Patient under tutorship or guardianship, and incapable to give informed consent","64 Years",{"count":217,"type":23},62,[183],"Dermatomyositis (DM) is a rare and disabling condition with an important impairment of quality of life and possible life-threatening complications.\n\nTreatment is based on high doses of corticosteroids but this exposes patients to adverse events (cardiovascular mortality, glucocorticoids-induced muscle and skin damages). Corticosteroids taper is associated with disease relapses. Although there is no evidence from the literature, clinical practice guidelines recommends the use of DMARDs such as methotrexate. However, response is not complete and these DMARDS take time to act.\n\nThe interferon type I (IFN-I) pathway is involved in the pathophysiology of DM. Janus kinase 1 and 2 transduces IFN-I signals. In addition, JAK2 inhibition enhances muscle repair and force generation.\n\nJAK 1\u002F2 inhibitors permitted to dramatically and rapidly improve relapsing DM patients (n=4, case series).\n\nOur hypothesis is that Janus kinase 1 and 2 (JAK1\u002F2) inhibitors (baricitinib) will permit to obtain dermatomyositis (DM) improvement with a steroid sparing effect as compared to usual care.\n\nOur primary objective is to evaluate the efficacy of baricitinib (JAK1\u002F2 inhibitor) to obtain prednisone-free moderate improvement (ACR\u002FEULAR ≥ 40) of DM as compared to placebo in addition to usual care.\n\nBIRD is a multicenter phase III double blind randomized placebo-controlled trial with two parallel arms (1:1). This is an add-on trial to usual care with rapid corticoid taper.\n\nThis is a multicenter trial in different medical departments in hospitals across France in different regions.\n\nOut- and in patients will be recruited in hospital departments involved in management and diagnosis of DM: departments of dermatology, rheumatology and internal medicine.",[27],[27,222,223],"baricitinib","steroid sparing","2026-05-29",{"date":226,"type":41},"2026-06-02",{"date":228,"type":41},"2022-08-31",{"date":230,"type":23},"2028-02-28",{"name":170,"class":79},{"id":233,"slug":234,"hasResults":12,"nctId":235,"briefTitle":236,"officialTitle":236,"acronym":237,"eligibilityCriteria":238,"healthyVolunteers":12,"sex":18,"minAge":239,"maxAge":240,"enrollmentInfo":241,"targetDuration":4,"studyType":58,"phases":242,"briefSummary":244,"conditions":245,"keywords":251,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":265,"lastUpdatePostDateStruct":266,"startDateStruct":268,"completionDateStruct":270,"leadSponsor":272,"locationsCount":80},"100592874","teams-engaged-in-accessible-mental-health-interventions-for-lupus-erythematosus-and-dermatomyositis-stress-100592874","NCT06999109","Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress","TEAM-LEADS","Inclusion Criteria:\n\n* Diagnosis of juvenile-onset systemic lupus erythematosus (JSLE) or dermatomyositis (JDM)\n* Age 13-22 years old at time of enrollment\n\nExclusion Criteria:\n\n* Inability to complete surveys\u002Finterviews reliably\n* Lack of access to internet-enabled device;\n* Non-JSLE\u002FJDM diagnosis\n* History of myocardial infarction or cerebrovascular accident\n* Evidence of severe emotional distress defined as any of the following at time of screening: a) Patient Health Questionnaire for Adolescents (PHQ9A) score ≥ 15 indicating severe depression; b) PHQ9A suicidality item score \\> 0 indicating presence of any suicidal ideation; c) any other evidence noted of severe emotional distress per PI's judgment.","13 Years","22 Years",{"count":7,"type":23},[243],"NA","The objectives of this study are to determine if the 'Teams Engaged in Accessible Mental Health Interventions for Lupus Erythematosus and Dermatomyositis Stress' (TEAM-LEADS) intervention is feasible and acceptable to adolescents and young adults with lupus and dermatomyositis and whether it can help reduce stress and promote cardiovascular health behaviors in these individuals.",[246,247,27,248,249,250],"Lupus","Dermatomyositis, Juvenile","Lupus Erythematosus","Lupus Erythematosus, Systemic","Lupus or SLE",[252,253,254,246,27,255,256,257,258,259,260,261,262,263,264],"Stress","Depression","Anxiety","Pediatric Rheumatology","Physical Activity","Diet Quality","Sleep","Cardiovascular Health","Health Behaviors","Remote Intervention","Online Intervention","Co-Design","Intervention Refinement","2026-05-22",{"date":267,"type":41},"2026-05-27",{"date":269,"type":23},"2027-02-01",{"date":271,"type":23},"2029-01-15",{"name":273,"class":79},"Duke University",{"id":275,"slug":276,"hasResults":12,"nctId":277,"briefTitle":278,"officialTitle":279,"acronym":4,"eligibilityCriteria":280,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":281,"targetDuration":4,"studyType":58,"phases":283,"briefSummary":284,"conditions":285,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":286,"lastUpdatePostDateStruct":287,"startDateStruct":289,"completionDateStruct":291,"leadSponsor":293,"locationsCount":295},"100569788","phase-3-a-study-to-understand-how-the-study-medicine-dazukibart-works-in-people-with-idiopathic-inflammatory-myopathies-100569788","NCT06698796","A Study to Understand How the Study Medicine Dazukibart Works in People With Idiopathic Inflammatory Myopathies","A PHASE 3, MULTI-CENTER, OPEN-LABEL EXTENSION STUDY TO INVESTIGATE THE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF DAZUKIBART IN PARTICIPANTS WITH IDIOPATHIC INFLAMMATORY MYOPATHIES (INCLUDING PARTICIPANTS WITH DERMATOMYOSITIS OR POLYMYOSITIS)","Inclusion Criteria:\n\n* Participants that completed a qualifying study through Week 52.\n\nExclusion Criteria:\n\n* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation\u002Fbehavior or laboratory abnormality that may increase the risk of study participation.\n* Previous administration with an investigational product (drug or vaccine) other than dazukibart in a qualifying study within 30 days (or as determined by the local requirement) or 5 half-lives preceding baseline in this study (whichever is longer).\n* Current use of any prohibited concomitant medication(s).\n* Active bacterial, viral, fungal, mycobacterial or other infections.\n* Ongoing adverse event in a qualifying study or the participant has met safety monitoring criteria in a qualifying study that have not resolved.\n* Investigator site staff or sponsor employees directly involved in the conduct of the study, site staff otherwise supervised by the investigator, and their respective family members.",{"count":282,"type":23},211,[183],"The purpose of this study is to understand how the study medicine, dazukibart, works in people with active idiopathic inflammatory myopathies (dermatomyositis \\[DM\\] or polymyositis \\[PM\\]).\n\nIdiopathic inflammatory myopathies are a group of disorders that show inflammation of the muscles used for movement. There are several types of idiopathic inflammatory myopathies, including DM and PM.\n\nDM and PM involve weakness of the muscles closest to the center of the body, such as the muscles of the hips, thighs, upper arms, and neck. People with these forms of idiopathic inflammatory myopathies may find it difficult to climb stairs, get up from a seated position, or lift items above their head. People with DM can also have a skin rash.\n\nThese disorders negatively impact the quality of life and functioning of patients. In addition to the above, these disorders can affect how the lungs and heart work.\n\nThis study is seeking participants who took part in a DM and PM study with dazukibart before. Some participants will receive study medicine, and some participants will not receive study medicine and only complete safety follow-up.\n\nThe study medicine will be given as an intravenous (IV) infusion (directly into the veins). This takes about 1 hour, every 4 weeks, from Day 1 to Week 48 (about 12 months) of the study. This will be followed by a safety follow-up period that lasts about 4 months after the last infusion. Participants who receive study medicine will have about 18 study visits at the site over about 16 months.\n\nThere will also be participants enrolled in this study who will not receive study medicine. Such participants will only take part in safety follow-up visits as they do not want to or are not eligible to receive dazukibart. These participants will not receive study medicine and will have up to 4 study visits at the site every 4 weeks to complete safety follow-up.",[27,28],"2026-05-14",{"date":288,"type":41},"2026-05-15",{"date":290,"type":41},"2025-01-22",{"date":292,"type":23},"2027-11-25",{"name":294,"class":205},"Pfizer",24,{"id":297,"slug":298,"hasResults":12,"nctId":299,"briefTitle":300,"officialTitle":301,"acronym":302,"eligibilityCriteria":303,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":304,"targetDuration":4,"studyType":58,"phases":306,"briefSummary":307,"conditions":308,"keywords":312,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":314,"lastUpdatePostDateStruct":315,"startDateStruct":317,"completionDateStruct":319,"leadSponsor":321,"locationsCount":80},"100567794","phase-2-intralesional-injection-of-sts-in-treatment-of-calcinosis-100567794","NCT06672822","Intralesional Injection of STS in Treatment of Calcinosis","An Open Label Evaluation of Intralesional Injection of Sodium Thiosulfate in the Treatment of Cutaneous or Tendon Calcinosis in Connective Tissue Disease","STSINJ","Inclusion Criteria:\n\n* Clinical diagnosis of systemic sclerosis, mixed connective tissue disease or inflammatory myopathy\n* Must be over 18 years of age\n* Participants must be competent to give informed consent\n* Participants must have radiographic evidence (xray or ultrasound) of calcinosis.\n* Participants must need symptomatic relief\n\nExclusion Criteria:\n\n• Pregnant women will be excluded",{"count":305,"type":23},20,[60],"The specific objective of this study is to perform a small, open-label study to assess the safety and efficacy of intralesional, subcutaneous injection of STS on calcinosis symptoms and lesion size in systemic sclerosis (SSc), mixed connective tissue disease (MCTD) and dermatomyositis (DM) patients. Injection will be guided by ultrasound, lesion size assessed by ultrasound, and symptom burden by patient-reported outcome measures.",[309,27,310,311],"Systemic Sclerosis (SSc)","Mixed Connective Tissue Disease (MCTD)","Calcinosis",[313],"calcinosis","2026-05-03",{"date":316,"type":41},"2026-05-05",{"date":318,"type":41},"2025-03-17",{"date":320,"type":23},"2029-05-01",{"name":322,"class":79},"Robyn T. Domsic, MD, MPH",{"id":324,"slug":325,"hasResults":12,"nctId":326,"briefTitle":327,"officialTitle":327,"acronym":4,"eligibilityCriteria":328,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":329,"enrollmentInfo":330,"targetDuration":4,"studyType":58,"phases":332,"briefSummary":333,"conditions":334,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":336,"lastUpdatePostDateStruct":337,"startDateStruct":339,"completionDateStruct":341,"leadSponsor":343,"locationsCount":80},"100635912","exploratory-clinical-study-of-anti-cd19bcma-universal-car-t-cell-injection-for-the-treatment-of-refractory-autoimmune-diseases-100635912","NCT07558850","Exploratory Clinical Study of Anti-CD19\u002FBCMA Universal CAR-T Cell Injection for the Treatment of Refractory Autoimmune Diseases","Inclusion Criteria:\n\n* Common Inclusion Criteria\n\n  1. Voluntarily sign an informed consent form, understand the study, and be willing and capable of completing all trial procedures.\n  2. Aged 18 to 70 years, regardless of gender.\n  3. At screening, the number of peripheral blood CD19-positive B cells determined by flow cytometry \\> 5 cells\u002FμL.\n  4. For subjects previously treated with B-cell targeted therapy, peripheral blood B cell counts have returned to normal or above pre-treatment levels at the screening visit.\n  5. Complete blood counts within 7 days prior to lymphodepleting chemotherapy meet the following requirements in patients with Sjögren's disease (SjD):\n\n     Absolute neutrophil count (ANC) ≥ 1.5×10⁹\u002FL Hemoglobin (Hb) ≥ 80 g\u002FL Platelet count (PLT) ≥ 50×10⁹\u002FL\n  6. Subjects have adequate hepatic, renal, pulmonary and cardiac function at screening visit, defined as:\n\n     Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤ 2.5 × upper limit of normal (ULN) Total bilirubin (TBIL) ≤ 1.5 × ULN; except for patients with Gilbert syndrome, whose TBIL must be ≤ 3.0 × ULN Renal function: estimated glomerular filtration rate (eGFR) ≥ 30 mL\u002Fmin\u002F1.73m². Subjects with eGFR \\\u003C 30 mL\u002Fmin\u002F1.73m² and\u002For receiving renal replacement therapy may be enrolled if the investigator assesses benefits outweigh risks and full informed consent is obtained from the subject or guardian.\n\n     Peripheral oxygen saturation (SpO₂) ≥ 92% under room air without oxygen supplementation; no clinically significant pleural effusion (excluding that related to the target indication).\n\n     Left ventricular ejection fraction (LVEF) ≥ 50%; no pericardial effusion confirmed by echocardiography (excluding indication-related effusion); no clinically significant abnormalities on electrocardiogram (ECG).\n  7. During the screening period, serum pregnancy test must be negative for fertile female subjects. Females who have undergone surgical sterilization or natural menopause for at least 2 years are considered non-fertile. Fertile female and male subjects must adopt highly effective contraceptive methods throughout the clinical study and for 1 year after the last study treatment. They shall also agree not to donate oocytes or sperm for assisted reproductive technology within 1 year following the final study treatment.\n\n     Specific Inclusion Criteria\n\n     Relapsed\u002FRefractory Rheumatoid Arthritis (RA)\n  8. Meet the 2010 ACR\u002FEULAR classification diagnostic criteria, diagnosed with moderate to severe active rheumatoid arthritis, with a confirmed RA diagnosis for ≥ 6 months.\n  9. Swollen joint count ≥ 6 (based on 66-joint assessment) and tender joint count ≥ 6 (based on 68-joint assessment) at screening.\n  10. C-reactive protein (CRP) ≥ 10 mg\u002FL or erythrocyte sedimentation rate (ESR) ≥ 28 mm\u002Fh at screening.\n  11. Definition of EULAR refractory rheumatoid arthritis:\n\n      Treatment failure: Patients received treatment in accordance with EULAR recommended guidelines, and failed to respond to ≥ 2 biological\u002Ftargeted synthetic disease-modifying antirheumatic drugs (b\u002FtsDMARDs) following failure of conventional synthetic DMARDs (csDMARDs).\n\n      ① Exclusions: Treatment access restricted to bDMARDs\u002FtsDMARDs due to socioeconomic factors.\n\n      ② If csDMARDs are contraindicated, treatment failure with ≥ 2 b\u002FtsDMARDs with distinct mechanisms of action also qualifies.\n\n      Both patients and physicians acknowledge persistent difficulties in managing RA symptoms.\n\n      Presence of at least one of the following five indicators suggestive of active or progressive disease:\n      1. Moderate or higher disease activity (DAS28-ESR \\> 3.2 or CDAI \\> 10);\n      2. Clinical signs and\u002For symptoms indicative of active disease;\n      3. Inability to taper glucocorticoids to ≤ 7.5 mg\u002Fday prednisone or equivalent dose;\n      4. Rapid radiographic progression (increase in modified van der Heijde Sharp score ≥ 5 points within 1 year);\n      5. Impaired quality of life secondary to RA, despite seemingly adequate disease control.\n\n      Dermatomyositis (DM)\n  12. Diagnosed with Dermatomyositis (DM) in accordance with the 2017 EULAR\u002FACR criteria for at least 24 weeks prior to informed consent (ICF) signing.\n  13. Meet the classification criteria for refractory DM, and satisfy criterion ① plus any one of criteria ②-⑤:① Insufficient response to glucocorticoids (prednisone 1-2 mg\u002Fkg\u002Fday or equivalent dose of other corticosteroids) combined or sequential treatment with at least two immunosuppressants, with glucocorticoid treatment lasting for no less than 3 months;② Rapid disease progression, and\u002For involvement of extrapulmonary organs including the heart and gastrointestinal tract, and\u002For significant interstitial lung disease;③ Calcification in subcutaneous, muscular and articular tissues;④ Recurrent rashes or cutaneous ulcers;⑤ Recurrent or persistent muscle weakness. MRI shows extensive diffuse muscle edema during the disease course, or CMAS score \\\u003C 48. At least two abnormal results among the five core parameters: Physician Global Assessment (PhGA) ≥ 2 cm, Patient Global Assessment (PtGA) ≥ 2 cm, Manual Muscle Test MDAAT ≥ 2, Health Assessment Questionnaire (HAQ) total score ≥ 0.25, muscle enzyme levels \\> 1.5 × upper limit of normal (ULN).\n  14. Patients with anti-synthetase syndrome and positive anti-synthetase antibodies meet DM criteria and may be enrolled directly.\n  15. Patients with immune-mediated necrotizing myopathy positive for SRP or HMGCR antibodies meet DM criteria and may be enrolled directly.\n\n      Systemic Lupus Erythematosus (SLE)\n  16. Diagnosed with adult systemic lupus erythematosus (SLE) in accordance with the 2019 EULAR\u002FACR SLE classification criteria for at least 12 weeks prior to signing the informed consent form (ICF).\n  17. Subjects with moderate to severe refractory SLE shall meet all of the following criteria:\n\n      Positive antinuclear antibody (ANA) with a titer \\>1:80 at screening visit; or anti-double stranded DNA antibody level above the laboratory normal reference range (excluding borderline values); or anti-Sm antibody level above the laboratory normal reference range.\n\n      BILAG score showing Grade A involvement in ≥1 organ system, or Grade B involvement in ≥2 organ systems at both screening and baseline visits.\n\n      SLEDAI-2000 score ≥ 8 at both screening and baseline visits. Insufficient clinical response following adequate standard-dose glucocorticoids, antimalarials, immunosuppressants, and at least one biological agent administered in combination or sequentially for ≥ 3 months prior to screening.\n  18. Subjects receiving hematopoietic growth factor supportive therapy, including erythropoietin (EPO), granulocyte colony-stimulating factor (G-CSF), granulocyte-macrophage colony-stimulating factor (GM-CSF) and thrombopoietin (TPO), must have an interval of at least 2 weeks between the last dose of growth factor therapy and screening assessments.For subjects receiving blood product transfusions: platelet assessments at screening shall be separated by at least 1 week from the last platelet transfusion; hemoglobin assessments at screening shall be separated by at least 2 weeks from the last red blood cell transfusion.\n\n      Systemic Sclerosis (SSc)\n  19. Meet the 2013 ACR\u002FEULAR classification criteria for systemic sclerosis, with disease duration ≤ 60 months.\n  20. Positive for antinuclear antibody (ANA) or any SSc-specific autoantibody.\n  21. Modified Rodnan Skin Score (mRSS) ≥ 15 (full score: 51).\n  22. Meet the definition of refractory disease:\n\n      * Significant progressive involvement of skin and visceral organs; ② No obvious disease remission after more than 3 months of combined or sequential treatment with glucocorticoids and\u002For cyclophosphamide, plus one or more immunomodulatory agents including but not limited to antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, ciclosporin, and biological agents such as rituximab, belimumab, telitacicept.Alternatively, subjects meeting criteria for rapidly progressive disease with no response to conventional standard clinical therapy may be enrolled if the investigator determines that clinical benefits outweigh risks and full informed consent is obtained from the subject or legal guardian.\n\nExclusion Criteria:\n\n* Common Exclusion Criteria\n\n  1. History of malignant tumors (excluding cured and completely resected basal cell carcinoma, squamous cell skin carcinoma or cervical carcinoma in situ with a disease-free interval of at least 5 years post resection), or concurrent malignant tumors.\n  2. Complicated severe pulmonary diseases, including pulmonary hypertension graded ≥ Grade 3 per WHO functional classification, requirement for oxygen therapy via oxygen reservoir mask, non-invasive or invasive mechanical ventilation support at screening.\n  3. Known allergy, hypersensitivity, intolerance or contraindication to CD19\u002FBCMA CAR-NK cells or any investigational medicinal ingredients (including fludarabine, cyclophosphamide and tocilizumab), or history of severe anaphylactic reactions.\n  4. Evidence of severe active viral, bacterial infection or uncontrolled systemic fungal infection at screening or baseline visit.\n  5. Cardiac insufficiency classified as NYHA Class Ⅲ or Ⅳ according to New York Heart Association criteria (see Appendix).\n  6. Congenital heart disease prior to screening, history of acute myocardial infarction within 6 months, severe arrhythmia (including multifocal frequent supraventricular tachycardia, ventricular tachycardia, etc.), moderate to massive pericardial effusion, severe myocarditis; unstable vital signs requiring vasopressor support.\n  7. Active or uncontrolled infection requiring parenteral antimicrobial therapy at screening or baseline visit.\n  8. Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral HBV DNA level above upper limit of normal; positive HCV antibody with peripheral HCV RNA level above upper limit of normal; positive HIV antibody, positive syphilis serology, or positive cytomegalovirus (CMV) DNA.\n  9. History of severe herpes infection such as herpes encephalitis, ocular herpes or disseminated herpes; signs of herpes or varicella-zoster virus infection (particularly varicella and herpes zoster) within 12 weeks prior to screening.\n  10. Active tuberculosis, history of active tuberculosis, or negative interferon-gamma release assay for tuberculosis infection not achieved during screening period.\n  11. History of epilepsy or other active central nervous system disorders.\n  12. Subjects with acquired or congenital immunodeficiency diseases.\n  13. Any clinically significant cardiac, endocrine, hematological, hepatic, immune, metabolic, urinary, pulmonary, neurological, dermatological, psychiatric, renal disorders or major medical history that may interfere with KN3601 administration, as judged by the investigator.\n  14. Solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; acute graft-versus-host disease (GVHD) Grade ≥2 within 2 weeks prior to screening.\n  15. Administration of live vaccines within 4 weeks prior to screening.\n  16. Receipt of the following treatments within specified time windows before baseline visit:\n\n      B-cell depleting therapy within 26 weeks Anti-CD40 monoclonal antibody, belimumab, abatacept, anti-tumor necrosis factor-α biologics, immunoglobulin therapy or plasma exchange within 24 weeks JAK inhibitors or other kinase inhibitors within 12 weeks, unless explicitly permitted by the protocol Traditional Chinese medicines and proprietary Chinese medicines for Sjögren's disease within 4 weeks (including Tripterygium wilfordii, Tripterygium hypoglaucum, Tripterygium hypoglaucum root, Paeonia lactiflora, and preparations\u002Fsupplements containing the above ingredients) Prior treatments within 3 elimination half-lives, 4 weeks, or ongoing pharmacodynamic effect, whichever is longer Post prior B-cell depleting therapy with B lymphocyte count below lower limit of normal or baseline value, whichever is lower\n  17. Participation in other clinical trials within 3 months, excluding subjects confirmed not to receive investigational drugs or devices.\n  18. Any conditions that, in the investigator's opinion, may elevate subject risk or confound trial outcomes.\n\n      Specific Exclusion Criteria Relapsed\u002FRefractory Rheumatoid Arthritis (RA)\n  19. ACR functional class Grade 4 for rheumatoid arthritis. Dermatomyositis (DM)\n  20. Paraneoplastic myositis, defined as myositis diagnosed within 2 years following cancer diagnosis, or subjects categorized as high-risk for malignancy.\n  21. Subjects with overlap syndrome (excluding overlap with Sjögren's syndrome), connective tissue disease-associated DM other than primary DM, inclusion body myositis, polymyositis, or drug-induced myopathy.\n  22. Subjects with severe systemic musculoskeletal disorders other than DM, which interfere with adequate investigator assessment of disease activity.\n\n      Systemic Lupus Erythematosus (SLE)\n  23. Renal pathological diagnosis of Class V lupus nephritis (excluding Class III or IV lupus nephritis complicated with Class V lupus nephritis); active nephritis requiring treatment with protocol-prohibited medications, or requirement for hemodialysis.\n\n      Systemic Sclerosis (SSc)\n  24. Concurrent rheumatic autoimmune diseases other than SSc, including but not limited to rheumatoid arthritis, systemic lupus erythematosus, mixed connective tissue disease, polymyositis and dermatomyositis, as determined by the investigator.Note: Subjects with fibromyalgia, secondary Sjögren's syndrome, and scleroderma-associated myopathy at screening will not be excluded.\n  25. Non-SSc cutaneous lesions that impair accurate investigator evaluation of disease activity.\n  26. History of scleroderma renal crisis occurring within 2 years prior to screening visit.","70 Years",{"count":331,"type":23},72,[243],"A single arm, open-label pilot study is designed to determine the safety and effectiveness of anti-CD19\u002FBCMA-UCAR-T cells in patients with autoimmune diseases.\n\n36-72 patients are planned to be enrolled in the dose-escalation trial.",[102,27,104,335],"Systemic Sclerosis","2026-04-23",{"date":338,"type":41},"2026-04-30",{"date":340,"type":23},"2026-05-10",{"date":342,"type":23},"2029-01-10",{"name":344,"class":79},"The First Affiliated Hospital with Nanjing Medical University",{"id":346,"slug":347,"hasResults":12,"nctId":348,"briefTitle":349,"officialTitle":350,"acronym":351,"eligibilityCriteria":352,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":353,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":354,"conditions":355,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":356,"lastUpdatePostDateStruct":357,"startDateStruct":359,"completionDateStruct":361,"leadSponsor":363,"locationsCount":80},"100281581","clinical-responsiveness-of-dermatomyositis-using-cutaneous-dermatomyositis-disease-area-and-severity-index-cdasi-100281581","NCT02945345","Clinical Responsiveness of Dermatomyositis Using Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)","Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI)","CDASI","Inclusion Criteria:\n\n* Gender\u002FAge: Males or females above 18 years old\n* Diagnosis: Cutaneous Dermatomyositis\n* Subjects able to give informed consent\n\nExclusion Criteria:\n\n* Subjects without cutaneous DM\n* Penn employees\n* Penn students\n* Cognitively impaired persons",{"count":89,"type":23},"The Evaluation of Clinical Responsiveness Using the Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI), established in 2008, is a one-site database study conducted at the University of Pennsylvania. The database has yielded valuable information and clinical insights into the pathophysiology, disease processes, including psychological responses, treatments and quality of life associated with dermatomyositis. The CDASI database incorporates the Cutaneous Dermatomyositis Disease Area and Severity Index), a validated outcome measure of disease responsiveness in patients, and other assessment tools, surveys and patient information to help validate the clinical course and quality of life of patients with dermatomyositis.\n\nThe CDASI database has led to publication of comparison studies of CDASI and other clinical instruments and the effect of dermatomyositis on Quality of Life (QoL).\n\nThe CDASI database is an ongoing resource that enables clinicians to evaluate the evolving clinical changes, treatment modalities and patient response to a challenging disease. Data will be analysed over a 5 years.",[27],"2026-03-24",{"date":358,"type":41},"2026-03-30",{"date":360,"type":41},"2008-06",{"date":362,"type":23},"2030-01-02",{"name":364,"class":79},"University of Pennsylvania",{"id":366,"slug":367,"hasResults":12,"nctId":368,"briefTitle":369,"officialTitle":369,"acronym":4,"eligibilityCriteria":370,"healthyVolunteers":17,"sex":18,"minAge":55,"maxAge":371,"enrollmentInfo":372,"targetDuration":374,"studyType":24,"phases":4,"briefSummary":375,"conditions":376,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":391,"lastUpdatePostDateStruct":392,"startDateStruct":394,"completionDateStruct":396,"leadSponsor":398,"locationsCount":80},"100393366","rheumatology-patient-registry-and-biorepository-100393366","NCT04402086","Rheumatology Patient Registry and Biorepository","Inclusion Criteria for Rheumatology Patients:\n\n* Patients ≥18 years old with a diagnosis of a rheumatic autoimmune disease including, but not limited to: adult onset Still's disease, ankylosing spondylitis, antiphospholipid syndrome, Behcet's disease, dermatomyositis, giant cell arteritis, mixed connective tissue disease, polymyalgia rheumatica, polymyositis, psoriatic arthritis, reactive arthritis, rheumatoid arthritis, sarcoidosis, scleroderma, Sjogren's syndrome, systemic lupus erythematosus, undifferentiated connective tissue disease and vasculitis.\n* Receiving clinical care at Yale Rheumatology clinics\n\nExclusion Criteria for Rheumatology Patients:\n\n* Unable to provide informed consent\n* No patients will be excluded based on gender or ethnicity or pregnancy status.\n* Women who are currently pregnant will need to wait to donate a skin biopsy until after they deliver.\n* Patients allergic to lidocaine or epinephrine or have a history of impaired wound healing will not be able to donate a skin biopsy.\n\nInclusion Criteria for Healthy Volunteers:\n\n* Age ≥ 18 years old\n* No chronic skin conditions\n* No diagnosis of a rheumatic autoimmune disease (e.g., lupus, rheumatoid arthritis)\n* Normal BMI\n\nExclusion Criteria for Healthy Volunteers:\n\n* Unable to provide informed consent.\n* Currently pregnant or nursing unless the study goal is to study pregnant or nursing woman.\n* Allergies to lidocaine or epinephrine (skin biopsies).\n* A history of impaired wound healing (skin biopsies).","99 Years",{"count":373,"type":23},5000,"10 Years","To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.",[377,378,379,101,380,381,104,382,27,28,383,384,385,386,102,387,335,388,389,390],"Rheumatic Diseases","Adult Onset Still Disease","Ankylosing Spondylitis","Reactive Arthritis","Antiphospholipid Syndrome","Behcet Disease","Giant Cell Arteritis","Lyme Disease","Mixed Connective Tissue Disease","Polymyalgia Rheumatica","Sarcoidosis","Scleroderma","Sjogren's Syndrome","Undifferentiated Connective Tissue Diseases","2026-02-11",{"date":393,"type":41},"2026-02-13",{"date":395,"type":41},"2020-08-04",{"date":397,"type":23},"2030-06-01",{"name":399,"class":79},"Yale University",{"id":401,"slug":402,"hasResults":12,"nctId":403,"briefTitle":404,"officialTitle":404,"acronym":405,"eligibilityCriteria":406,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":407,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":409,"conditions":410,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":415,"lastUpdatePostDateStruct":416,"startDateStruct":417,"completionDateStruct":419,"leadSponsor":421,"locationsCount":80},"100623942","a-long-term-follow-up-study-for-participants-previously-treated-with-kyv-101-100623942","NCT07403188","A Long-Term Follow-Up Study for Participants Previously Treated With KYV-101","KYSA-4","Inclusion Criteria:\n\n* Provided informed consent for the LTFU study\n* Received at least 1 infusion of KYV-101 as part of a previous KYV-101 parent treatment protocol\n\nExclusion Criteria:\n\n* Not applicable",{"count":408,"type":23},70,"The purpose of this long-term follow-up (LTFU) study is to collect delayed adverse events (AEs) and understand the persistence of KYV-101 (autologous CAR T cell product; gene-modified product), in participants who have been administered KYV-101 (gene-modified product; autologous CAR T cell product).\n\nThis LTFU protocol will be open to any participant who received at least one infusion of KYV-101 in a previous Kyverna sponsored clinical trial or Investigator Initiated Trial (IIT).",[411,412,413,414,99,27,309],"Refractory Lupus Nephritis","Myasthaenia Gravis","Stiff Person Syndrome","Rheumatoid Arthritis (RA)","2026-02-03",{"date":391,"type":41},{"date":418,"type":41},"2025-11-24",{"date":420,"type":23},"2041-01",{"name":422,"class":205},"Kyverna Therapeutics",{"id":424,"slug":425,"hasResults":12,"nctId":426,"briefTitle":427,"officialTitle":428,"acronym":429,"eligibilityCriteria":430,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":431,"enrollmentInfo":432,"targetDuration":4,"studyType":58,"phases":434,"briefSummary":435,"conditions":436,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":437,"lastUpdatePostDateStruct":438,"startDateStruct":440,"completionDateStruct":442,"leadSponsor":444,"locationsCount":80},"100621933","rct-of-tocilizumab-for-anti-mda5dm-100621933","NCT07377058","RCT of Tocilizumab for Anti-MDA5+DM","A Randomized, Double-Blind, Placebo-Controlled Clinical Study on the Efficacy and Safety of Tocilizumab in the Treatment of Anti-MDA5 Antibody-Positive Adult Dermatomyositis","PROMIS-MDA5","Inclusion Criteria:\n\n* All inclusion criteria must be met for eligibility:\n\n  1. Age ≥ 18 years and \\\u003C 65 years; no gender restriction; total body weight ≥ 45 kg;\n  2. Diagnostic Criteria for Anti-MDA5-DM: Refer to the \"2023 Chinese Expert Consensus on Diagnosis and Treatment of Anti-Melanoma Differentiation-Related Gene 5 Antibody-Positive Dermatomyositis in China.\" Dermatomyositis patients exhibiting one of the following manifestations-Gottron's papules, Gottron's rash, or erythema ab igne-along with positive serum anti-MDA5 antibodies, may be diagnosed with anti-MDA5-DM;\n  3. If patients have concomitant ILD, the following conditions must be met: i) Pulse oxygen saturation (SpO₂) ≥ 90% or PaO₂ ≥ 60 mmHg; ii) Pulmonary function tests showing forced vital capacity percentage of predicted (FVC%) ≥ 60% and carbon monoxide diffusion capacity percentage of predicted (DLco%) ≥ 40%; iii) High-resolution chest CT demonstrating pulmonary interstitial lesions involving \\\u003C 50% of lung fields;\n  4. Patients must have received oral prednisone (\\\u003C 1 mg\u002Fkg\u002Fday, or equivalent dose of other glucocorticoids) for ≥ 4 weeks prior to randomization;\n  5. Patients must have received a stable dose of a calcineurin inhibitor (CNI, such as cyclosporine or tacrolimus) for ≥4 weeks prior to randomization; if immunosuppressive therapy was discontinued prior to the screening visit, a washout period of at least 4 weeks is required;\n  6. Patients must receive prophylactic treatment with trimethoprim-sulfamethoxazole (TMP-SMZ, 400mg trimethoprim\u002F80mg sulfamethoxazole) 1-2 tablets daily during treatment;\n  7. Women of childbearing potential must have a negative pregnancy test at study entry. If sexually active, they must agree to use effective contraception throughout the study period and must not intend to become pregnant during the study.\n  8. Patients voluntarily participate in this study and sign an informed consent form.\n\nExclusion Criteria:\n\n* 1\\. Polymyositis, anti-synthetase syndrome, immune-mediated necrotizing myositis, or overlap myositis with other connective tissue diseases; 2. Patients with life-threatening complications, including but not limited to acute coronary syndrome (e.g., myocardial infarction, unstable angina) within 24 weeks prior to screening or any history of significant cerebrovascular disease; 3. Any of the following laboratory abnormalities at screening: white blood cell count \\\u003C3.0×10⁹\u002FL, neutrophil count \\\u003C1.0×10⁹\u002FL, lymphocyte count \\\u003C0.5×10⁹\u002FL, hemoglobin \\\u003C90 g\u002FL, platelet count \\\u003C50×10⁹\u002FL; severe hepatic impairment (ALT or AST ≥3 times ULN, total bilirubin ≥1.5 times ULN, excluding serum ALT or AST elevation due to dermatomyositis); severe renal impairment (creatinine clearance ≤45 mL\u002Fmin); 4. Patients hospitalized for severe infection within 60 days prior to screening, or who received intravenous antibiotics (patients who used intravenous antibiotics must complete a five-half-life washout period and confirm absence of active infection before enrollment), but may receive empirical oral antibiotics or topical antibiotics; 5. Active tuberculosis infection that is untreated or inadequately treated; Latent tuberculosis infection (LTBI) requires at least 2 weeks of preventive antituberculosis therapy (including at least 2 antituberculosis drugs) prior to randomization, continuing through study completion. LTBI is defined as: Positive IGRA result (acceptable IGRA assays include: QFT-GIT, QFT-G, and T-spot® TB test); 6. Active viral hepatitis at screening: HBsAg-positive, HBeAg-positive, or HBV-DNA \\>10³ copies\u002FL (HBV-DNA testing required if HBcAb-positive); HCVAb-positive; 7. Documented HIV infection, evidenced by positive serological test results or positive HIV serological test results at screening; 8. If the patient develops ILD-related clinical manifestations or progressive radiographic worsening within 4 weeks, RP-ILD should be considered. RP-ILD is defined as the presence of any one of the following four conditions within 1 month after the onset of respiratory symptoms: ① Acute and progressive worsening of dyspnea requiring hospitalization or supplemental oxygen; ② Decline in pulmonary function, manifested as a decrease in FVC% \\>10% with or without a decrease in DLco% \\>15%; ③ Increased interstitial abnormalities on chest HRCT scan \\>20%; ④ Decrease in arterial blood gas or partial pressure of oxygen \\>10 mmHg, indicating respiratory failure; and PaO₂\u002FFiO₂≥200 mmHg.\n\n  9\\. Allergy to the active ingredient tocilizumab or any of its excipients; 10. Patients with sulfonamide allergy; 11. Patients unable to complete pulmonary function testing at baseline; 12. Patients receiving prednisone at a dose exceeding 2 mg\u002Fkg\u002Fday prior to screening; 13. Patients receiving intravenous immunoglobulin (IVIG) prior to screening must discontinue treatment for at least 30 days; 14. Patients who used one or more of the following medications within the specified time window prior to screening:\n  1. Rituximab within 6 months prior to screening;\n  2. JAK inhibitors within 2 weeks prior to screening;\n  3. Use of other biologics (including but not limited to anakinra, adalimumab, infliximab) or other immunosuppressive agents (including but not limited to methotrexate, azathioprine, mycophenolate mofetil) within 4 weeks prior to screening; 15. Patients with prior use of the study drug, other IL-6 inhibitors, or analogues; 16. Pregnant or lactating women, or women planning to become pregnant or initiate lactation; 17. History of malignant tumors within the past 5 years (excluding adequately treated basal cell carcinoma of the skin, squamous cell carcinoma of the skin, or cervical carcinoma in situ with no evidence of recurrence within the preceding 5 years); 18. Other conditions deemed ineligible for study inclusion by the investigator.","65 Years",{"count":433,"type":23},110,[243],"The goal of this clinical trial is to learn if tocilizumab works to treat anti-MDA5+ dermatomyositis (anti-MDA5+DM) in adults. It will also learn about the safety of tocilizumab. The main questions it aims to answer are:\n\nDoes tocilizumab improve patients' clinical symptoms? Does tocilizumab improve patients' respiratory failure? What medical problems do participants have when taking tocilizumab? Researchers will compare tocilizumab to a placebo (a look-alike substance that contains no drug) to see if tocilizumab works to treat patients with anti-MDA5+ DM.\n\nParticipants will:\n\nTake tocilizumab or a placebo every two weeks for 2 months Visit the clinic once every 2 weeks for checkups and tests",[27],"2026-01-21",{"date":439,"type":41},"2026-01-29",{"date":441,"type":41},"2025-11-01",{"date":443,"type":23},"2026-10",{"name":445,"class":79},"Peking Union Medical College Hospital",{"id":447,"slug":448,"hasResults":12,"nctId":449,"briefTitle":450,"officialTitle":451,"acronym":452,"eligibilityCriteria":453,"healthyVolunteers":12,"sex":18,"minAge":454,"maxAge":4,"enrollmentInfo":455,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":457,"conditions":458,"keywords":462,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":472,"lastUpdatePostDateStruct":473,"startDateStruct":475,"completionDateStruct":477,"leadSponsor":479,"locationsCount":80},"100621706","mihra---patient-rooted-insights-for-shaping-myositis-science-prisms-100621706","NCT07374107","MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS)","MIHRA - Patient-Rooted Insights for Shaping Myositis Science (PRISMS) - A Qualitative Study of Patient-voiced Research Priorities Across Rare Myositis Diseases","MIHRA-PRISMS","Inclusion Criteria:\n\n* Ability to provide informed consent\n* Have a clinician diagnosis of an idiopathic inflammatory myopathy or be a care partner or parent of a person living with an idiopathic inflammatory myopathy.\n* Participants who may have signed up through the MIHRA Patient Contact Registry https:\u002F\u002Fmihrafoundation.org\u002Fmihra-programs\u002Fmihra-patient-contact-registry\u002F\n\nExclusion Criteria:\n\n* Under the age of 7 years old\n* Do not have a diagnosis of an inflammatory myopathy","7 Years",{"count":456,"type":23},700,"Myositis diseases are each rare diseases. As in other rare diseases, people living with myositis diseases face physical and psychosocial challenges that may not be recognized in current research priorities. The PRISMS study is a global investigation that collects patient perspectives through (mostly online) methods of open-ended questions, community forums and survey to identify the most pressing research concerns as identified by patients. Findings will be analyzed to create a patient-voiced set of research priorities that can guide the direction of research and help inform funding decisions across myositis diseases.\n\nPotential participants can express interest via https:\u002F\u002Fmihrafoundation.org\u002Fmihra-programs\u002Fmihra-patient-contact-registry\u002F",[459,460,35,461,27,247,195,188,28,29,190,127],"IBM","IIM","Inflammatory Myopathy",[463,464,465,466,467,468,469,470,471],"myositis","rare diseases","patient priorities","patient engagement","patient initiated","patient research partners","qualitative research","mixed methods research","research priorities","2026-01-20",{"date":474,"type":41},"2026-01-28",{"date":476,"type":41},"2025-06-25",{"date":478,"type":23},"2030-12",{"name":480,"class":79},"Myositis International Health & Research Collaborative Alliance Foundation",{"id":482,"slug":483,"hasResults":12,"nctId":484,"briefTitle":485,"officialTitle":485,"acronym":486,"eligibilityCriteria":487,"healthyVolunteers":12,"sex":18,"minAge":488,"maxAge":4,"enrollmentInfo":489,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":490,"conditions":491,"keywords":493,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":495,"lastUpdatePostDateStruct":496,"startDateStruct":498,"completionDateStruct":499,"leadSponsor":501,"locationsCount":80},"100619540","panniculitis-in-dermatomyositis-100619540","NCT07345949","Panniculitis in Dermatomyositis","PANNICUL","Inclusion Criteria:\n\n* Subject aged 1 year and older\n* With a confirmed diagnosis of dermatomyositis\n* With a confirmed diagnosis of panniculitis\n\nExclusion Criteria:\n\n* Panniculitis for which another cause has been established, particularly infectious and metabolic panniculitis","1 Year",{"count":305,"type":23},"Adipose tissue involvement is rare in dermatomyositis. The occurrence of partial or diffuse lipodystrophy is a rare but well-characterized manifestation, particularly in juvenile forms of dermatomyositis. Panniculitis, on the other hand, is exceptional and rarely described in the literature, mostly in the form of clinical cases.\n\nPanniculitis in dermatomyositis is exceptional. There are no validated diagnostic criteria or treatment recommendations. Treatment is based, by analogy, on the therapeutic strategy for lupus panniculitis and involves synthetic antimalarials combined with steroids and\u002For immunosuppressants.\n\nThe aim of this study is to describe panniculitis in dermatomyositis in order to determine whether there are clinical or histological characteristics that distinguish it from other causes of panniculitis, particularly panniculitis associated with lupus erythematosus.",[492,27],"Panniculitis",[492,27,494],"Adipose tissue","2026-01-07",{"date":497,"type":41},"2026-01-16",{"date":166,"type":41},{"date":500,"type":23},"2028-04-20",{"name":502,"class":79},"University Hospital, Strasbourg, France",{"id":504,"slug":505,"hasResults":12,"nctId":506,"briefTitle":507,"officialTitle":507,"acronym":508,"eligibilityCriteria":509,"healthyVolunteers":12,"sex":18,"minAge":510,"maxAge":4,"enrollmentInfo":511,"targetDuration":4,"studyType":24,"phases":4,"briefSummary":513,"conditions":514,"keywords":515,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":516,"lastUpdatePostDateStruct":517,"startDateStruct":519,"completionDateStruct":521,"leadSponsor":523,"locationsCount":80},"100613393","severity-factors-of-dermatomyositis-in-the-caribbean-population---dm-antilles-100613393","NCT07265999","Severity Factors of Dermatomyositis in the Caribbean Population - DM-ANTILLES","DM-ANTILLES","Inclusion Criteria:\n\n* Patient with a diagnosis of dermatomyositis according to the 2003 ENMC criteria\n* Patient with parents or grandparents originating from the Caribbean arc\n* Patient aged 16 years or older\n* Patient residing in Guadeloupe\n* Patient (or legal representative) who has received information about the study and has signed the informed consent form\n* Patient affiliated with a social security scheme\n\nExclusion Criteria:\n\n* Patient who started treatment with intravenous immunoglobulins, corticosteroids, or immunosuppressants within the month prior to the diagnosis of dermatomyositis\n* Patient under legal protection (guardianship or trusteeship) or deprived of liberty","16 Years",{"count":512,"type":23},10,"Dermatomyositis is a rare chronic autoimmune and inflammatory disease that affects the skin and striated muscles. Its prognosis is linked to visceral involvement (lungs, heart, and oropharyngeal region) and to the possible presence of associated cancer. The implementation of the research will allow identification of incident cases of dermatomyositis in Guadeloupe and the characterization of the disease in the overseas population, in the absence of data in the literature.",[27],[27],"2025-12-03",{"date":518,"type":41},"2025-12-05",{"date":520,"type":41},"2021-07-16",{"date":522,"type":23},"2029-07-16",{"name":524,"class":79},"Centre Hospitalier Universitaire de la Guadeloupe",{"id":526,"slug":527,"hasResults":12,"nctId":528,"briefTitle":529,"officialTitle":529,"acronym":4,"eligibilityCriteria":530,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":531,"enrollmentInfo":532,"targetDuration":4,"studyType":58,"phases":534,"briefSummary":535,"conditions":536,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":537,"lastUpdatePostDateStruct":538,"startDateStruct":540,"completionDateStruct":542,"leadSponsor":544,"locationsCount":80},"100581971","phase-2-topical-ruxolitinib-cream-for-refractory-cutaneous-dermatomyositis-100581971","NCT06857240","Topical Ruxolitinib Cream for Refractory Cutaneous Dermatomyositis","Inclusion Criteria:\n\n* Patients 18 years and older with refractory cutaneous symptoms related to either classic dermatomyositis (CD), juvenile dermatomyositis (JD), or amyopathic dermatomyositis (AD). Diagnosis will be based on either Bohan and Peter criteria (CD and JD) or Sontheimer's criteria (AD) (19-22).\n* Patients must have had a skin biopsy with histologic features consistent with dermatomyositis and current cutaneous manifestations consistent with dermatomyositis.\n* Patients will be considered to have refractory disease if cutaneous manifestations exist despite treatment with systemic corticosteroids and at least one steroid-sparing systemic treatment commonly found to be useful in patients with dermatomyositis. These may include azathioprine, cyclosporine, mycophenolate mofetil, IVIG, methotrexate, hydroxychloroquine, cyclophosphamide, chlorambucil, sirolimus, tacrolimus, and rituximab.\n* Patients must have sufficiently active cutaneous involvement of dermatomyositis (BSA\\>1% to \\\u003C20%, CDASI activity score \\> 6, and Physician Global Assessment (PGA) activity score \\>2).\n* Patients must have tried and failed at least one commonly prescribed topical medication in the past, with the last application of a topical medication to active skin lesions occurring greater than 2 weeks prior to enrollment.\n\n  o Commonly prescribed topical medications for dermatomyositis include corticosteroids or calcineurin inhibitors (tacrolimus or pimecrolimus).\n* Patients must have been on a stable systemic medication regimen for at least 2 months (60 days) and must agree to keep the regimen stable throughout the study period. As patients with dermatomyositis are commonly treated with combination regimens that include both topical and systemic immunosuppressive medications, any added risk of adverse effects related to ruxolitinib 1.5% cream is considered negligible.\n* Patients must be agreeable to use appropriate contraceptive measures while enrolled in the study.\n\n  * Women of childbearing potential must be willing to practice abstinence or use either an oral contraceptive medication or IUD if sexually active.\n  * Women of childbearing potential must be willing to have monthly urine pregnancy tests while enrolled in the study\n  * Men of childbearing potential must be willing to practice abstinence or use condoms if sexually active.\n\nExclusion Criteria:\n\n* Patients with dermatomyositis who have minimal-to-no active cutaneous disease (mild involvement with \\\u003C 1% total body surface area involved and\u002For CDASI activity score of \\\u003C 6).\n* Patients who have \\> 20% total BSA involvement of cutaneous dermatomyositis.\n* Patients who have used a common prescription topical medication within the previous 2 weeks.\n* Patients whose cutaneous findings are not consistent with dermatomyositis and\u002For have previous biopsy results suggestive of an alternative diagnosis\n* Patients not on stable systemic medication regimens for at least 2 months and\u002For who will not agree to keep the regimen stable throughout the study period.\n* Patients who have previously taken a systemic Janus kinase inhibitor but had a poor response, patients who are currently taking systemic Janus kinase inhibitors, or patients who have used a topical Janus kinase inhibitor for their dermatomyositis or any other condition and had poor responses.\n* Patients with inflammatory myositis other than dermatomyositis, such as polymyositis or inclusion body myositis.\n* Patients with clear features of an overlap autoimmune myositis or with an inflammatory myositis not consistent with dermatomyositis, such as polymyositis or inclusion body myositis.\n* Patients with an active malignancy other than non-melanoma skin cancer, or with malignancy-associated dermatomyositis.\n* Patients younger than 18 years old","89 Years",{"count":533,"type":23},15,[60],"This study will assess the safety and efficacy of topical ruxolitinib for treating the refractory cutaneous manifestations in patients with dermatomyositis. The investigators' hypothesis is that topical ruxolitinib will be both safe and effective for such patients.",[27],"2025-10-03",{"date":539,"type":41},"2025-10-08",{"date":541,"type":41},"2025-06-01",{"date":543,"type":23},"2027-12",{"name":545,"class":79},"The Cleveland Clinic",{"id":547,"slug":548,"hasResults":12,"nctId":549,"briefTitle":550,"officialTitle":550,"acronym":551,"eligibilityCriteria":552,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":4,"enrollmentInfo":553,"targetDuration":4,"studyType":58,"phases":554,"briefSummary":555,"conditions":556,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":557,"lastUpdatePostDateStruct":558,"startDateStruct":560,"completionDateStruct":562,"leadSponsor":564,"locationsCount":80},"100542811","phase-1-car-t-cells-in-systemic-b-cell-mediated-autoimmune-disease-100542811","NCT06347718","CAR-T Cells in Systemic B Cell Mediated Autoimmune Disease","CASTLE","Inclusion Criteria:\n\n* General:\n\n  * Subjects must understand and voluntarily sign an informed consent form including written consent for data protection,\n  * Adults aged ≥ 18 years at time of consent,\n  * Adequate renal (eGFR \\> 30 ml\u002Fmin\u002Fm2), liver (no Child Pugh C), heart (at worst NYHA III, EF \\> 30%) and pulmonary (FV and DLCO \\> 30%) function,\n  * Male subjects unless surgically sterile, must agree to use two acceptable methods for contraception (e.g. spermicide and condom) during the trial and refrain from fathering a child starting from the time of signing the Informed Consent Form (ICF) until 12 months after dosing of the IMP,\n  * Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl in-dex \\\u003C1) starting from the time of signing the ICF and for 12 months after dosing of the IMP,\n  * Must be able to adhere to the study visit schedule and other protocol requirements,\n  * Double vaccination against SARS-CoV-2 or SARS-CoV-2 within the last 6 months.\n* SLE specific:\n\n  * Fulfilling the 2019 ACR\u002FEULAR classification criteria of SLE,\n  * Positivity of anti-dsDNA (\\> 4 U\u002Fl), anti-histone (+ or more), anti-nucleosome (+ or more) or anti-Sm antibodies (+ or more),\n  * Active disease at screening, defined as ≥ 1 organ system with a British Isles Lupus Assessment (BILAG) A score (severe disease activity) or ≥ 2 organ systems with a BILAG B score (moderate disease activity),\n  * Insufficient response or intolerance\u002F contraindication to glucocorticoids and to at least 2 of the following treatments: hydroxychloroquine, mycophenolate mofetil, belimumab, methotrexate, rituximab, cyclophosphamide. Insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point.\n* SSc specific:\n\n  * Fulfilling the 2013 ACR\u002FEULAR classification criteria of SSc),\n  * Positivity (+ or more) for at least one SSc-specific parameter (Scl70, RNA polymerase, Th\u002FTo, RP11\u002F12, U3RNP autoantibodies),\n  * Signs for fast progression including (i) disease duration ≤ 5 years (from onset of first non-Raynaud manifestation), (ii) mRSS score 10-35 at screening, (iii) elevated acute phase reactant levels (CRP ≥ 6 mg\u002FL, ESR ≥ 28mm\u002Fh or platelet count ≥ 330 G\u002FL), (iii) mRSS increase ≥ 3 units or involvement of one new body area or mRSS increase ≥ 2 units in one body area or ≥ 1 tendon friction rub over 6 months,\n  * Insufficient response or intolerance\u002F contraindication to at least 2 of the following treatments: mycophenolate mofetil, azathioprine, nintedanib, methotrexate, rituximab. Insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point.\n* DM\u002FPM specific:\n\n  * Fulfilling the 2017 ACR\u002FEULAR classification criteria for probable or definite DM or PM,\n  * Presence of active myositis in muscle biopsy or muscle MRI and\u002For signs of interstitial lung disease related to DM\u002FPM,\n  * Positivity (+ or more) for at least one myositis-specific antibody (aminoacyl tRNA synthetases, Mi2, MDA5, SAE, SRP, ARS, HMGCR, MJ, TIF1gamma),\n  * Muscle weakness as define by MMT \\\u003C 142 and 2 of the following criteria: VAS patients Global ≥2cm, VAS physician Global ≥ 2cm, HAQ \\> 0.25, at least one muscle enzyme \\> 1.3 times upper limit of normal, VAS global extra muscular activity ≥ 2cm,\n  * Insufficient response or intolerance\u002F contraindication to glucocorticoids and to at least 2 of the following treatments: mycophenolate mofetil, ciclosporin A, tacrolimus, methotrexate, rituximab, intravenous immunoglobulins. Insufficient response is defined as having increased disease activity based on the definition explained in the previous bullet point.\n\nExclusion Criteria:\n\n* Clinically suitability for a less burdensome and\u002For approved therapeutic approach, as judged by the investigator\n* ANC \\\u003C 1.000\u002Fmm3, ALC \\\u003C 500\u002Fmm3 or hemoglobin \\\u003C 8g\u002Fdl, absolute CD3+ T cell count \\\u003C 100\u002Fμl,\n* Uncontrolled severe concomitant disease, such as cancer (except basal or squamous cell skin cancer) and diabetes mellitus,\n* Severely impaired renal (eGFR ≤ 30 ml\u002Fmin\u002Fm2), liver (Child Pugh C), heart (NYHA IV, EF ≤ 30%) and pulmonary (FV and DLCO ≤ 30%) function,\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if the subject were to participate in the study or confounds the ability to interpret data from the study,\n* Prior treatment with anti-CD19 antibody therapy, adoptive T cell therapy or any prior gene therapy product (e.g. CAR T cell therapy),\n* History of bone marrow\u002F hematopoietic stem cell or solid organ transplantation,\n* Any concomitant severe active infection, e.g. HIV, hepatitis B or C, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If presence of latent tuberculosis is established then treatment according to local guidelines must have been initiated prior to enrollment,\n* Diagnosis of severe neuropsychiatric SLE, inclusion body myositis or limited SSc,\n* Pregnant or lactating females,\n* Females who are intending to conceive during the study,\n* Known hypersensitivity to any drug components,\n* Malignancy in the last 5 years before screening,\n* Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis,\n* Subjects who are younger than 18 years or are incapable to understand the aim, importance and consequences of the study and to give legal informed consent,\n* Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration, or may interfere with interpretation of results,\n* Subjects who possibly are dependent on the Sponsor, the Principal Investigator or other Investigators (e.g. family members).",{"count":295,"type":23},[91,60],"The investigational product is designed to effectively combat B cells in patients with autoimmune diseases. Autologous T cells enriched with CD4\u002FCD8 are genetically engineered using a lentiviral vector to express chimeric antigen receptors (CARs) that target the CD19 antigen on the cell surface of B cells and their precursors. During treatment, patients undergo leukapheresis, lymophodepleting chemotherapy and administration of the expanded CD19-CAR-transduced T cells.",[104,335,27,28],"2025-09-24",{"date":559,"type":41},"2025-09-30",{"date":561,"type":41},"2023-07-17",{"date":563,"type":23},"2026-05-31",{"name":565,"class":205},"Miltenyi Biomedicine GmbH",{"id":567,"slug":568,"hasResults":12,"nctId":569,"briefTitle":570,"officialTitle":571,"acronym":4,"eligibilityCriteria":572,"healthyVolunteers":12,"sex":18,"minAge":573,"maxAge":4,"enrollmentInfo":574,"targetDuration":4,"studyType":58,"phases":576,"briefSummary":577,"conditions":578,"keywords":579,"overallStatus":69,"whyStopped":4,"lastUpdateSubmitDate":581,"lastUpdatePostDateStruct":582,"startDateStruct":584,"completionDateStruct":586,"leadSponsor":588,"locationsCount":57},"100602372","phase-2-phase-2-trial-to-evaluate-the-efficacy-safety-of-allogeneic-mitochondria-pn-101-in-patients-with-refractory-polymyositis-or-dermatomyositis-100602372","NCT07122648","Phase 2 Trial to Evaluate the Efficacy, Safety of Allogeneic Mitochondria (PN-101) in Patients With Refractory Polymyositis or Dermatomyositis","A Prospective, Multi-center, Randomized, Double-blinded, Placebo-controlled, Parallel, Phase 2 Trial to Evaluate the Efficacy, Safety of PN-101(Mitochondria Isolated From Allogeneic Umbilical Cord-derived Mesenchymal Stem Cells) Single Dose in Patients With Refractory Polymyositis or Dermatomyositis","Inclusion Criteria:\n\n1. Adult aged 19 years or more\n2. A subject who is diagnosed with polymyositis or dermatomyositis and satisfies all of the followings:\n\n   * Clinical profile: Slowly progressing clinical profile with symmetrical and apparent muscular weakness confirmed at the proximal muscle (in case of dermatomyositis, clinical findings related with characteristic skin symptoms\\*)\n\n     * Gottron's papules or sign, erythema purpura, poikiloderma, calcinosis cutis, etc.\n   * Serum test: Serum creatine kinase (CK) elevated (CK ≥ 1.3 × upper limit of normal (ULN)) or serum myositis-specific antibodies (MSA) positive\n   * Electromyography (EMG): Presence of a finding that indicates myopathy\n3. Baseline (prior to the investigational product administration) manual muscle testing-8 (MMT-8) result \\\u003C 125\u002F150 (bilaterally), and at least 2 of the following International Myositis and Clinical Studies Group (IMACS) core set results\n\n   * Physician global disease activity \\[visual analogue scale (VAS)\\] ≥ 2 cm\n   * Patient global disease activity \\[VAS\\] ≥ 2 cm\n   * Health assessment questionnaire (HAQ) disability assessment ≥ 0.25\n   * 1 or more items with the serum muscle enzyme \\> 1.3 × ULN\n   * Global extramuscular disease activity \\[VAS\\] \\> 1 cm\n4. Individuals who are currently receiving glucocorticosteroids and\u002For steroid-sparing drugs such as immunosuppressants or immunomodulators for the treatment of polymyositis or dermatomyositis but are deemed to have an inadequate response to treatment, or who are unable to continue existing treatment due to drug-related adverse events or side effects (however, during the clinical trial, the dosage of steroids and immunosuppressants may be adjusted within 20% of the dose prior to the study participation)\n5. Individuals who are receiving exercise or physical therapy and have agreed to maintain the same intensity and frequency of their current therapy\n6. A subject who fully understands the trial and provided voluntary written consent to take part in the trial\n\nExclusion Criteria:\n\nSubjects who meet any of the following criteria will not be eligible to participate in this clinical trial:\n\n1. A subject with clear muscular damage, with the VAS-based myositis damage index (MDI) of ≥ 5 at screening\n2. A subject with the following medical history or surgical history\n\n   * A surgical operation history within 12 weeks of screening\n   * Malignant tumor within 5 years of screening (excluding a subject who passed 3 years or more from complete recovery of cervical cancer or skin squamous cell carcinoma)\n3. Patients diagnosed with polymyositis or dermatomyositis before the age of 10 (Juvenile PM or Juvenile DM)\n4. A patient with severe respiratory muscular weakening or interstitial pulmonary disease (a patient who has no moderate or severe dyspnea and has stable interstitial pneumonia may participate)\n5. A patient with the following comorbidity at screening\n\n   * Acute viral infection or severe infection\n   * Active hepatitis B (e.g.: HBsAg positive and HBV DNA detected) or hepatitis C (e.g.: Anti-HCV positive and HCV RNA \\[qualitatively\\] detective)\n   * Human Immunodeficiency virus (HIV) positive\n   * Findings of muscular inflammation or myopathy other than the indication (inclusion body myositis (IBM), drug-induced myopathy, amyloid myopathy, myotonic dystrophy, etc.)\n   * Autoimmune disease such as rheumatoid arthritis (RA), systemic lupus erythematosus, psoriatic arthritis, etc. (however, in case of the overlap syndrome, a subject may participate if diseases other than inflammatory myositis are stable and myositis is thought to be due to inflammatory myositis.)\n   * Findings of cardiac disorder such as moderate or severe heart failure (New York Heart Association Class III\u002FIV) or QT corrected interval prolonged\n   * Serious disease that may affect this study, at the discretion of the investigator (neurological disorder, cardiovascular disorder, uncontrolled blood pressure or diabetes, etc.)\n6. Hematological, renal and hepatic dysfunction based on the following laboratory findings at screening\n\n   * Glomerular filtration rate (GFR)\\* \\\u003C 45 mL\u002Fmin \\*eGFR (mL\u002Fmin\u002F1.73m\\^2) = 175 × (serum creatinine concentration (mg\u002FdL))\\^-1.154 × (age)\\^-0.203 × (0.742 in female) \\[modification of diet in renal disease (MDRD) formula\\]\n   * Hemoglobin \\\u003C 10 g\u002FdL\n   * White blood cell (WBC) count \\\u003C 3.0×10\\^9\u002FL\n   * Absolute neutrophil count (ANC) \\\u003C 1.5×10\\^9\u002FL (1500\u002Fmm\\^3)\n   * Platelet count \\\u003C 100×10\\^9\u002FL\n   * AST and ALT \\> 2.5 × ULN (except for the elevation due to muscle enzyme at the discretion of the investigator)\n   * Alkaline phosphatase (ALP) \\> 2.5 × ULN\n   * Total bilirubin \\> 1.5 × ULN (\\> 3 × ULN, in case of Gilbert's syndrome)\n   * Thyroid stimulating hormone level exceeding the normal range (however, if the level exceeds the normal range due to the study indication at the discretion of the investigator, the subjects are allowed to enroll.)\n7. A subject with a difficulty in the efficacy assessment including the muscular strength assessment during the trial\n8. A subject who is determined to require prohibited concomitant treatment during the trial\n9. Pregnant woman and lactating mother or woman of childbearing potential and man who is planning to have a child or not willing to practice acceptable contraception\\* for 36 weeks after the last dosing date \\*Hormonal contraception, intrauterine device or intrauterine system implant, surgical sterilization procedure\u002Foperation (vasectomy, tubal ligation, etc.)\n10. Participation in other clinical trial and administration of an investigational product or application of an investigational device within 4 weeks or half-life x 5 (whichever is longer) prior to screening\n11. A subject who is otherwise ineligible for this trial, at the discretion of the investigator","19 Years",{"count":575,"type":23},36,[60],"The efficacy of PN-101 in subjects with polymyositis or dermatomyositis will be evaluated at Week 12 using IMACS-TIS in comparison with the placebo control group. The safety and efficacy will be evaluated following administration of PN-101 to subjects with polymyositis or dermatomyositis, in comparison with the placebo group",[28,27],[580],"mitochondria","2025-08-07",{"date":583,"type":41},"2025-08-14",{"date":585,"type":23},"2025-12",{"date":587,"type":23},"2027-04",{"name":589,"class":205},"Paean Biotechnology Inc.",{"id":591,"slug":592,"hasResults":12,"nctId":593,"briefTitle":594,"officialTitle":595,"acronym":4,"eligibilityCriteria":596,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":597,"enrollmentInfo":598,"targetDuration":4,"studyType":58,"phases":600,"briefSummary":601,"conditions":602,"keywords":604,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":607,"lastUpdatePostDateStruct":608,"startDateStruct":609,"completionDateStruct":611,"leadSponsor":613,"locationsCount":80},"100595824","photoacousticultrasound-imaging-in-patients-of-dermatomyositis-with-calcinosis-cutis-characteristic-findings-and-treatment-response-evaluation-100595824","NCT07037472","Photoacoustic\u002FUltrasound Imaging in Patients of Dermatomyositis With Calcinosis Cutis: Characteristic Findings and Treatment Response Evaluation","A Cohort Study Establishing a Standardized Scoring System in Dermatomyositis With Calcinosis Cutis and Assessing Treatment Response Via Multimodal Photoacoustic-Ultrasound Imaging","Inclusion Criteria:\n\n* All patients fulfilled the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myositis. Of the adult DM patients enrolled, those were found to have calcinosis and were subsequently included in our analysis.\n* Among enrollees with idiopathic inflammatory myositis, patients with pathognomonic skin rashes were subclassified as DM or amyopathic DM patients based on the 2017 EULAR\u002FACR classification tree.\n* For patients without pathognomonic skin manifestations, DM was defined according to muscle biopsy.\n* Patients with amyopathic DM were grouped with DM patients.\n* Calcinosis diagnosis was based on clinical examination findings.\n\nExclusion Criteria:\n\n* Patients whose age at disease onset was \\\u003C18 years and those with overlap syndrome and\u002For IBM were excluded.","80 Years",{"count":599,"type":23},100,[243],"Photoacoustic imaging (PAI) is an emerging biomedical modality that integrates the advantages of optical contrast and ultrasound imaging depth. Capable of providing morphological, functional, and molecular information, PAI shows significant promise for visualizing human superficial tissue. The goal of this clinical trial is to build a PAI evaluation method for DM skin lesions, explore its application value in assessing DM disease severity and evaluation of treatment response. The main questions it aims to answer are:\n\n1. How to establish a non-invasive PA\u002FUS imaging evaluation method for DM skin lesions?\n2. Can PAI precisely assess DM disease severity?\n3. Can PAI systems predict the treatment response in DM with calcinosis cutis? Participants will receive regular PA\u002FUS imaging examinations during five stages of treatment (before treatment, 3 months, 6 months, 9 months and 12 months). And the effectiveness of PA\u002FUS in treatment response for DM at different time points will be evaluated.",[27,603],"Dermatomyositis With Calcinosis Cutis",[27,605,606],"Dermatomyositis with Calcinosis cutis","Photoacoustic imaging","2025-06-16",{"date":476,"type":41},{"date":610,"type":41},"2024-01-01",{"date":612,"type":23},"2028-12-31",{"name":445,"class":79},{"id":615,"slug":616,"hasResults":12,"nctId":617,"briefTitle":618,"officialTitle":619,"acronym":4,"eligibilityCriteria":620,"healthyVolunteers":12,"sex":18,"minAge":621,"maxAge":622,"enrollmentInfo":623,"targetDuration":4,"studyType":58,"phases":625,"briefSummary":626,"conditions":627,"keywords":628,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":632,"lastUpdatePostDateStruct":633,"startDateStruct":635,"completionDateStruct":637,"leadSponsor":639,"locationsCount":641},"100538990","phase-1-study-of-kyv-101-anti-cd19-car-t-therapy-in-adult-dermatomyositis-100538990","NCT06298019","Study of KYV-101 Anti-CD19 CAR T Therapy in Adult Dermatomyositis","Phase 1B, Open-Label Study of KYV-101, an Autologous Fully-Human Anti-CD19 Chimeric Antigen Receptor T-Cell (CD19 CAR T) Therapy, in Adult Patients With Treatment Refractory Dermatomyositis","Inclusion Criteria:\n\n1. Diagnosis of probable or definite (\\>55%) IIM and subgroup classification as dermatomyositis according to the 2017 EULAR\u002FACR classification criteria for idiopathic inflammatory myopathies.\n2. Age \\> 25 years and \\\u003C 72 years at time of signing informed consent Refractory disease: subject with previous failure (or intolerance) to glucocorticoids and at least two non-glucocorticoid immunosuppressive therapies (including mycophenolate mofetil or mycophenolic acid, cyclophosphamide, azathioprine, methotrexate, calcineurin inhibitors, tofacitinib or other JAK inhibitors, rituximab, or IVIG) administered for at least 12 weeks within 24 months prior to screening.\n\n.Moderate-to-severe dermatomyositis as per EITHER: muscle weakness, defined as Manual Muscle Testing (MMT-8) score \\\u003C142\u002F150; or cutaneous disease as per Cutaneous Dermatomyositis Assessment and Severity Index-activity subscore (CDASI-a)\\>=19.\n\nPLUS at least 2 other abnormal IMACS Core Set Measures (CSMs) from the following:\n\n* Patient global VAS≥2 cm.\n* Physician's global VAS ≥2 cm.\n* Global extramuscular activity score ≥2 cm.\n* Elevation of at least one of the muscle enzymes (CK, AST, ALT, aldolase, LDH) \\>1.5 times upper limit of normal.\n* HAQ-DI≥0.25.\n\n  2.For patients enrolling on the MMT-8 criterion, muscle disease must be active, as deemed by one of the following:\n* Creatine kinase, aldolase, LDH, AST, or ALT (if deemed due to muscle inflammation by investigator) ≥2×ULN.\n* MRI evidence of active myositis within last 3 months.\n* EMG evidence of active myositis within last 3 months.\n\nOther inclusion criteria: Subject must sign a written ICF prior to any screening procedures.\n\n1. Subject must be ≥25 and ≦72 years of age.\n2. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n3. Adequate organ function as per table below. Haematology Haemoglobin: ≥10.0 g\u002Fdl (without prior red blood cell transfusion within 7 days before the laboratory test)a Platelets: ≥100,000\u002F μL (without transfusion support within 7 days before the laboratory test).\n\n   Absolute Lymphocyte Count (ALC):≥700\u002FμL Absolute Neutrophil Count (ANC) 1,500\u002FμL (prior growth factor support is permitted but must be without support in the 7 days prior to the laboratory test) Hepatic AST and ALT: ≤2.5×upper limit of normal (ULN) unless deemed by the investigator to be secondary to DM.\n\n   Total bilirubin ≤1.5×ULN; except in subjects with congenital bilirubinaemia, such as Gilbert syndrome (in which case direct bilirubin ≤1.5×ULN is required) Renal Creatinine clearance Calculated creatinine clearance ≥45 mL\u002Fmin\u002F1.73 m2 (measured by Cockcroft-Gault equation) Pulmonary Grade≤1 dyspnoea Oxygen saturation measured by pulse oximetry ≥92% on room air a .For subjects who meet the inclusion criteria at screening, transfusion of red blood cells is permitted after screening as needed to maintain a haemoglobin level ≥8.0 g\u002FdL.\n4. Must be up to date on all recommended vaccinations, including against COVID-19\u002F SARS CoV-2, per Centers for Disease Control and Prevention or institutional guidelines for immune-compromised individuals.\n5. Women of childbearing potential must have a negative pregnancy test at screening using a highly sensitive serum pregnancy test (β-human chorionic gonadotropin \\[β-hCG\\]). Women of childbearing potential are defined as a sexually mature woman who has not undergone a hysterectomy or tubal ligation or who has not been naturally postmenopausal for at least 24 consecutive months.\n6. Female subjects of childbearing potential who have a fertile male sexual partner must agree to use a highly effective method of contraception (failure rate of \\\u003C1% per year when used consistently and correctly) from the time of signing the ICF until 1 year after the KYV-101 infusion. Examples of highly effective method of contraception include:\n\n   * Established use of hormonal methods of contraception associated with inhibition of ovulation (eg, oral, inserted, injected, implanted, transdermal), provided the subject or male subject's female partner plans to remain on the same treatment throughout the entire study and has been using that hormonal contraceptive for an adequate period of time to ensure effectiveness.\n   * Correctly placed copper containing- intrauterine device or intrauterine hormone-replacing system.\n   * Male sterilization with absence of sperm in the post-vasectomy ejaculate.\n   * Female sterilization (bilateral tubal ligation\u002Fbilateral salpingectomy or bilateral tubal occlusive procedure (provided that occlusion has been confirmed).\n   * Sexual abstinence, defined as completely and persistently refraining from all heterosexual intercourse (including during the entire period of risk associated with the study treatments) may obviate the need for contraception ONLY if this is the preferred and usual lifestyle of the subject.\n7. Male subjects, if not surgically sterilized, must agree to use highly effective method of contraception and not donate sperm from the time of signing the ICF until 1 year after the KYV-101 infusion.\n8. For females: a negative pregnancy test at screening and prior to lymphodepletion chemotherapy.\n9. Women and men must agree not to donate eggs (ova, oocytes) or sperm, respectively, until at least 1 year after receiving a KYV-101 infusion.\n\nEXCLUSION CRITERIA:\n\nDM-related exclusion criteria\n\n1. Evidence of any of the following:\n\n   * Severe muscle damage as per one of the following criteria:\n\n     1. Myositis Global Damage Index (MDI) ≥5.\n     2. Severe proximal muscle atrophy of upper or lower extremity on MRI.\n     3. Severe proximal muscle atrophy of upper or lower extremity on clinical examination.\n     4. Wheelchair-bound at home.\n     5. MMT-8 of ≤80.\n   * MDA5-positive rapidly progressing interstitial lung disease (subjects with stable ILD not requiring supplemental oxygen are eligible).\n   * Findings of muscular inflammation or myopathy other than the indication, such as polymyositis (PM), immune mediated necrotizing myopathy (IMNM), inclusion body myositis (IBM), cancer-associated myositis (myositis diagnosed within 2 years of cancer), drug-induced myopathy, amyloid myopathy, muscular dystrophy, metabolic myopathies, or myositis in the context of significant overlap with another systemic autoimmune rheumatologic disease (overlap myositis), except with Sjogren's syndrome.\n   * Generalized, severe musculoskeletal or neuro-muscular conditions other than DM that prevent a sufficient assessment of the patient by the investigator.\n2. Subject with any of the following:\n\n   * Patients with ILD associated with any of the following oRequiring O2 therapy and\u002For FVC ≤45% of predicted or DLCO ≤40% of predicted at screening oEvidence of PH as defined as estimated RVSP or ≥45 mmHg or right atrial or ventricular enlargement or dilatation, unless subsequent RHC shows no PH.\n\noPAH on right heart catheterization requiring PAH specific treatment.\n\n•Current gangrene of a digit\n\nOther exclusion criteria:\n\n1. Prior treatment with cellular immunotherapy (eg, CAR T) or gene therapy product directed at any target.\n2. History of allogeneic or autologous stem cell transplant.\n3. Systemic autoimmune disease, other than DM, requiring systemic immunosuppressive therapies\n4. Plan to receive live, attenuated vaccine after signing ICF (inactive vaccines, like the flu vaccine, are allowed). Unable to washout or interrupt autoimmune disease therapy prior to apheresis as specified in Table .\n5. Positive hepatitis B surface antigen (HBsAg) and hepatitis C serology confirmed by polymerase chain reaction (PCR) (except hepatitis C cured with pharmacotherapy); subjects who are HBsAg negative and hepatitis B core antibody (HBc) positive with no detectable DNA will be allowed into the study but will require regular monitoring of hepatitis B virus (HBV) DNA.\n6. Positive serology for human immunodeficiency virus (HIV).\n7. Positive screening test for SARS-Cov-2.\n8. Primary immunodeficiency.\n9. History of splenectomy.\n10. History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder investigator considers would increase the risk for the subject.\n11. Impaired cardiac function or clinically significant cardiac disease including:\n\n    1. Unstable angina or myocardial infarction or coronary artery bypass graft (CABG) within 6 months prior to apheresis.\n    2. New York Heart Association (NYHA) stage III or IV congestive heart failure.\n    3. History of clinically significant cardiac arrhythmia (eg, ventricular tachycardia), complete left bundle branch block, high-grade atrioventricular (AV) block.\n    4. History of severe nonischaemic cardiomyopathy.\n    5. Left ventricular ejection fraction (LVEF) \\\u003C45% as assessed by echocardiogram (ECHO)\n12. Previous or concurrent malignancy with the following exceptions:\n\n    1. Adequately treated basal cell or squamous cell carcinoma (adequate wound healing is required prior to screening).\n    2. In situ carcinoma of the cervix or breast, treated curatively and without evidence of recurrence for at least 3 years prior to screening.\n    3. A primary malignancy which has been completely resected, or treated, and is in complete remission for at least 5 years prior to screening.\n13. Serious and\u002For uncontrolled medical condition that, in the investigator's judgment, would cause unacceptable safety risk, interfere with study procedures or results, or compromise compliance with the protocol, such as:\n\n    1. Active, uncontrolled, viral, bacterial or systemic fungal infection (including human T cell lymphotropic virus \\[HTLV\\], human polyomavirus 2 \\[JC virus\\], or syphilis); or recent history of repeated infections.\n    2. Requirement of supplemental oxygen to maintain oxygen saturation.\n    3. Clinical evidence of dementia or altered mental status.\n    4. A thromboembolic event within 6 months prior to apheresis.\n14. Ongoing toxicity from previous therapy that has not resolved to baseline levels or to Grade 1 or less, except for alopecia, fatigue, nausea, and constipation.\n15. Major surgery within 4 weeks prior to apheresis or planned within 4 weeks after KYV-101 administration. For surgery planned after 4 weeks post KYV-101 administration, discuss with the sponsor.\n16. Contraindications or life-threatening allergies, hypersensitivity, or intolerance to KYV-101 or its excipients, including dimethyl sulfoxide; or to CYC (or to fludarabine if relevant), or to tocilizumab.\n17. Pregnant or breastfeeding; or plans to become pregnant or breastfeed, or father a child within 1 year after receiving the KYV-101 infusion.","25 Years","72 Years",{"count":624,"type":23},21,[91],"The goal of this clinical trial is to characterize to understand the effects of a type of cell therapy called Chimeric Antigen Receptor T lymphocyte (CAR T) therapy in adult patients with the autoimmune disease dermatomyositis. This study will utilize a technology that modifies a type of white blood cell called the cytotoxic T lymphocyte-this T cell normally functions in the immune system to kill infected or potentially harmful cells in the body. In CAR T therapy, the patients' white blood cells are harvested and the cytotoxic T cells are isolated and modified such that they are programmed to kill any cell that has a protein structure called \"CD19\" on its outer surface (membrane). Since the CD19 protein is only present on a type of white blood cell called the B lymphocyte, when these \"re-engineered\" cytotoxic T lymphocytes are then given back to the patient (by an infusion), these cells will seek out and kill essentially all of the patient's B cells. B cells are an important part of a person's immune system and have many functions, including the production of antibodies. It is thought that, in dermatomyositis and other autoimmune diseases, a tiny subset of these B cells plays a large role in making autoantibodies (antibodies directed against the patient's own tissues) and causing disease. The idea is that the therapy will \"wipe out\" all\u002Fmost of the B cells in the patient so that they can make an entirely new set of B cells to recreate a functional immune system without the autoimmune disease.\n\nThe main questions the study intends to answer are:\n\n* Understanding how well patients tolerate undergoing this therapy in terms of side effects;\n* Getting an early idea if this therapy can help certain aspects of the autoimmune disease, including inflammation in the skin, muscles, and lungs;",[27],[629,630,631],"CAR T","CD19","KYV-101","2025-05-18",{"date":634,"type":41},"2025-05-21",{"date":636,"type":41},"2024-08-02",{"date":638,"type":23},"2039-04",{"name":640,"class":79},"Stanford University",2,{"id":643,"slug":644,"hasResults":12,"nctId":645,"briefTitle":646,"officialTitle":646,"acronym":647,"eligibilityCriteria":648,"healthyVolunteers":12,"sex":18,"minAge":55,"maxAge":431,"enrollmentInfo":649,"targetDuration":4,"studyType":58,"phases":650,"briefSummary":651,"conditions":652,"keywords":4,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":655,"lastUpdatePostDateStruct":656,"startDateStruct":658,"completionDateStruct":660,"leadSponsor":661,"locationsCount":80},"100568731","phase-1-anti-cd19-car-t-cell-therapy-in-refractory-systemic-autoimmune-diseases-100568731","NCT06685042","Anti-CD19 CAR T-Cell Therapy in Refractory Systemic Autoimmune Diseases","CATARSIS","Inclusion criteria\n\n* General\n\n  1. Subjects must understand and voluntarily sign an informed consent form, including written consent for data protection;\n  2. Adults aged ≥ 18 years and \\\u003C 65 years at time of consent;\n  3. Male subjects, unless surgically sterile, must agree to use two acceptable methods for contraception (e.g., spermicide and condom) during the trial and refrain from fathering a child starting from the time of signing the Informed Consent Form (ICF) until 12 months after dosing of the IMP;\n  4. Females of childbearing potential (FCBP) must have a negative urine pregnancy test at screening and must agree to use a highly effective contraceptive method (Pearl index \\\u003C1) starting from the time of signing the ICF and for 12 months after dosing of the IMP;\n  5. Must be able to adhere to the study visit schedule and other protocol requirements;\n  6. Double vaccination (2 doses) against SARS-CoV-2 or SARS-CoV-2 within the last 6 months.\n* SLE subjects\n\n  a) Fulfilling the 2019 ACR\u002FEULAR classification criteria of SLE; b) Presence of anti-dsDNA, anti-histone, anti-nucleosome or anti-Sm antibodies; c) Active disease at screening, defined as ≥1 organ system with a British Isles Lupus Assessment (BILAG) A score (severe disease activity) or ≥2 organ systems with a BILAG B score (moderate disease activity); d) Insufficient response to glucocorticoids and at least 2 of the following treatments: hydroxychloroquine, mycophenolate mofetil, belimumab, methotrexate, rituximab.\n* SSc subjects\n\n  1. Fulfilling the 2013 ACR\u002FEULAR classification criteria of SSc;\n  2. Diffuse SSc with respective autoantibody profile;\n  3. Signs for fast progression including i) disease duration ≤5 years (from onset of first non-Raynaud manifestation), ii) mRSS score 10-35 at screening, iii) elevated acute phase reactant levels (CRP ≥ 6 mg\u002FL, ESR ≥ 28mm\u002Fh or platelet count ≥ 330 000\u002Fmm3), iii) mRSS increase ≥ 3 units or involvement of one new body area or mRSS increase ≥ 2 units in one body area or ≥1 tendon friction rub over 6 months;\n  4. Insufficient response to glucocorticoids and to at least 2 of the following treatments:\n\nmycophenolate mofetil, azathioprine, nintedanib, methotrexate, rituximab.\n\n* DM\u002FPM subjects\n\n  a) Fulfilling the 2017 ACR\u002FEULAR classification criteria for probable or definite DM or PM57, b) Muscle weakness as defined by MMT \\\u003C 142 and 2 of the following criteria: VAS patients Global ≥ 2 cm, VAS physician Global ≥ 2 cm, HAQ \\> 0.25, at least one muscle enzyme \\>1.3 times upper limit of normal, VAS global extra muscular activity ≥ 2 cm; c) Presence of at least one myositis-specific antibody; d) Insufficient response to glucocorticoids and to at least 2 of the following treatments: mycophenolate mofetil, ciclosporin A, tacrolimus, methotrexate, rituximab, and intravenous immunoglobulins.\n* AAV subjects\n\n  1. Fulfilling the 2022 ACR\u002FEULAR classification criteria for MPA\u002FGPA\u002FEGPA,\n  2. Presence of ANCA to either proteinase 3 or myeloperoxidase;\n  3. At least one major or three non-major items or at least two renal items of hematuria and proteinuria on the BVAS;\n  4. Failure of at least 1 of the following treatments: glucocorticoids, cyclophosphamide, or B-cell targeting therapy.\n\nExclusion criteria\n\n* Clinically suitability for a less burdensome and\u002For approved therapeutic approach, as judged by the investigator;\n* ANC \\\u003C 1.000\u002Fmm3, ALC \\\u003C 500\u002Fmm3 or hemoglobin \\\u003C 8 g\u002Fdl, absolute CD3+ T cell count ≤100\u002Fµl;\n* Evidence of significant and uncontrolled concomitant diseases that could affect compliance with the protocol or interpretation of results.\n* Relevant cardiovascular disease: recent history of myocardial infarction, cardiac angioplasty or stenting, unstable angina, significant arrhythmia, congestive heart failure, or left ventricular ejection fraction \\\u003C 50%, as determined by echocardiography\n* Any condition, including the presence of laboratory abnormalities, which places the subject at unacceptable risk if he\u002Fshe were to participate in the study or confounds the ability to interpret data from the study;\n* Impaired renal function, i.e., eGFR \\\u003C 30 ml\u002Fmin;\n* Patients with evidence on thorax CT of advanced fibrotic interstitial lung disease and whose latest pulmonary function test showed a Forced Vital Capacity (FVC) \\\u003C 40% of predicted or a Diffusing Capacity for Carbon Monoxide (DLCO) \\\u003C 30% of predicted\n* Any concomitant severe active infection, including HIV (even with negative viral load), active hepatitis B (either positive for Hepatitis B core antibody \\[HBcAb\\] or positive hepatitis B surface antigen \\[HBsAg\\] and NAT tests) and\u002For C (\\\u003C12 weeks between achievement of a sustained virological response to the specific treatment and apheresis) according to the American Association for the Study of Liver Diseases guidelines, SARS-CoV 2 (COVID 19), or active tuberculosis as defined by a positive Quantiferon TB-test. If the presence of latent tuberculosis is established, then treatment according to local guidelines must have been initiated before enrolment;\n* Pregnant or lactating females;\n* Known hypersensitivity to either any drug components or any auxiliary medicinal products scheduled during trial participation, including during lymphodepletion;\n* Malignancy in the last 5 years before screening. The inclusion of patients with previously completely resected carcinoma in situ who have not required treatment other than surgery is allowed.\n* Previous CAR T cell administration;\n* A therapeutic schedule not compatible with the wash-out requirements for the leukapheresis procedure (section 5.8.1 of CSP) and the medications permitted during the study (section 7.11 of CSP);\n* Concurrent treatment with other investigational agents or participation in other investigational trials.\n* Treatment, as part of an investigational clinical trial, with an experimental product with a definite or potential effect on T or B-cells in the previous 2 years.\n* Requirement for immunization with live vaccine during the study period or within 14 days preceding leukapheresis;\n* Subjects who are younger than 18 years or are incapable of understanding the aim, importance, and consequences of the study and giving legal informed consent;\n* Have a history of alcohol or substance abuse within the preceding 6 months that, in the opinion of the Investigator, may increase the risks associated with study participation or study agent administration or may interfere with the interpretation of results;\n* Subjects who possibly are dependent on the Sponsor, the Principal Investigator, or the Investigator (e.g., family members).\n* Limited to patients diagnosed with SLE: patients with a history of severe central nervous system (CNS) involvement, including those who have presented aseptic meningitis, cerebral vasculitis, cerebrovascular disease, demyelinating syndrome, myelopathy, seizure disorder, status epilepticus, and severe lupus headache, will be excluded.\n* Patients meeting the classification criteria for multiple connective diseases such as overlapping SLE and Sjogren's Syndrome (SS) or SLE and Rheumatoid Arthritis (RA) and patients diagnosed with Mixed Connective Tissue Disease (MCTD).",{"count":140,"type":23},[91,60],"The CATARSIS study explores the use of anti-CD19 CAR T-cell therapy as a novel approach for treating refractory systemic autoimmune diseases, specifically SLE, SSc, DM\u002FPM, and AAV. These life-threatening conditions often resist current therapies, and B cells play a key role in their pathogenesis. The study employs CD19-CAR\\_Lenti, an autologous CAR T-cell product targeting CD19-positive B cells, aiming to reduce inflammation and autoimmunity. This open-label, single-dose, phase I basket trial will assess the safety, feasibility, and preliminary efficacy of CAR T-cell therapy, focusing on adverse events, infection rates, and overall response at 24 weeks. Eight participants will be included.",[249,653,654,27,28],"System; Sclerosis","ANCA Associated Vasculitis","2025-04-10",{"date":657,"type":41},"2025-04-11",{"date":659,"type":41},"2024-11-29",{"date":585,"type":23},{"name":662,"class":79},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS",{"id":664,"slug":665,"hasResults":12,"nctId":666,"briefTitle":667,"officialTitle":667,"acronym":668,"eligibilityCriteria":669,"healthyVolunteers":12,"sex":18,"minAge":670,"maxAge":4,"enrollmentInfo":671,"targetDuration":4,"studyType":58,"phases":673,"briefSummary":674,"conditions":675,"keywords":677,"overallStatus":37,"whyStopped":4,"lastUpdateSubmitDate":681,"lastUpdatePostDateStruct":682,"startDateStruct":684,"completionDateStruct":686,"leadSponsor":688,"locationsCount":140},"100330481","phase-2-subcutaneous-injection-of-sodium-thiosulfate-for-ectopic-calcifications-or-ossifications-a-pilot-study-100330481","NCT03582800","Subcutaneous Injection of Sodium Thiosulfate for Ectopic Calcifications or Ossifications. A Pilot Study","ITS-PILOT","Inclusion Criteria:\n\n* Patient presenting with:\n\n  * ectopic ossification secondary to iPPSD2 or\n  * ectopic calcification secondary to dermatomyositis or\n  * ectopic calcification secondary to systemic sclerosis\n* Patient aged 2 years or over\n* Indication of STS infusion validated by a multidisciplinary committee, based on the significant morbidity and\u002For functional impact of the targeted calcification\u002Fossification\n* Patient with no planned surgery of the calcifications\u002Fossifications for the twelve coming months\n* Women of childbearing potential on highly effective contraception (such as hormonal contraception, intrauterine device, intrauterine hormone-releasing system, bilateral tubal occlusion, vasectomised partner or sexual abstinence)\n* Men with women of childbearing potential partners should use condoms during the whole treatment period and until 91 days after the last injection.\n* Informed consent signed by the patient \u002F parents\n* Patient affiliated to the social security system\n\nExclusion Criteria:\n\n* Allergy to STS or one of the excipients used\n* Contraindication to local injection of STS\n* Anticoagulant therapy\n* Pregnant, parturient or breastfeeding woman\n* Patient deprived of freedom by a court judgment or an administrative decision\n* Patient undergoing psychiatric care under coercion\n* Legally protected adult patients (guardianship \u002F curatorship)\n* Patient unable to give consent\n* Patient placed under judicial protection","6 Months",{"count":672,"type":23},40,[60],"Ectopic soft tissue calcifications or ossifications can complicate the course of numerous diseases; most of them are rare or very rare. Even if the clinical, radiological and pathological presentation of ectopic calcifications and ossifications are different, the same hypotheses are discussed considering their hypothetical pathophysiology. Indeed, high calcium phosphate product, local cellular lesions and abnormal transdifferentiation of mesenchymal cells are regularly evoked when pathophysiology of such calcifications or ossifications are discussed. Apart from several case reports that have not been confirmed so far, no medical treatments are available, leading to significant pain and impairment of quality of life for patients. Therefore, only surgical treatment can be proposed when the volume or the consequences of these calcifications\u002Fossifications become too important.\n\nSodium thiosulfate (STS) is currently used as a cyanide poisoning antagonist and a chemoprotectant against adverse effects of several chemotherapies such as Cisplatin. Numerous case reports and several studies have revealed the potential interest of STS in the treatment of uremic induced vascular or soft tissues calcifications. Recently, our group has developed an expertise in the use of STS for the treatment of ectopic soft tissue calcifications or ossifications. Considering these promising preliminary data, and their limits, we developed a strategy to treat soft tissue calcifications or ossifications based on a local administration of STS. The first results of this therapeutic strategy are highly promising and the local or systemic safety is satisfactory so far. These preliminary data also reported by others deserve to be confirmed in a prospective study.\n\nWe propose in this project to conduct a prospective open controlled phase II trial in order to assess the efficacy and the safety of intralesional administration of STS for the treatment of calcifications secondary to dermatomyositis or systemic sclerosis and ectopic ossifications secondary to pseudo-hypoparathyroidism 1a type (PHP1A\u002FiPPSD2) (inactivating parathyroid hormone \u002F parathyroid-hormone-related peptid (PTH\u002FPTHrP) signalling disorder).",[335,27,676],"iPPSD2",[678,679,680],"Sodium thiosulfate","Ectopic calcification","Ectopic Ossification","2025-04-01",{"date":683,"type":41},"2025-04-04",{"date":685,"type":41},"2020-01-06",{"date":687,"type":23},"2027-06-06",{"name":689,"class":79},"University Hospital, Limoges"]