[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"polymyositis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:polymyositis":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,8,0,[8,47,71,97,138,177,199,225],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":20,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":37,"lastUpdatePostDateStruct":38,"startDateStruct":41,"completionDateStruct":4,"leadSponsor":43,"locationsCount":46},"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":21,"type":22},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.",[26,27,28],"Dermatomyositis","Polymyositis","Inclusion Body Myositis",[30,31,32,33,34,35],"Adult and Pediatric Disease","Autoimmunity Pathogenesis","Disease Assessment","Genetic and Environmental Risk Factors","Myositis","Natural History","RECRUITING","2026-06-27",{"date":39,"type":40},"2026-06-30","ACTUAL",{"date":42,"type":40},"1995-06-07",{"name":44,"class":45},"National Institute of Environmental Health Sciences (NIEHS)","NIH",4,{"id":48,"slug":49,"hasResults":11,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":16,"sex":17,"minAge":18,"maxAge":19,"enrollmentInfo":54,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":56,"conditions":57,"keywords":60,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":4,"leadSponsor":70,"locationsCount":5},"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":55,"type":22},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.",[34,26,27,58,59],"Juvenile Dermatomyositis","Juvenile Polymyositis",[61,62,63,31,64,35],"Adult and Pediatric Autoimmune Disease","Antibody","Autoimmune Diseases","Environmental Risk Factors","2026-06-11",{"date":67,"type":40},"2026-06-12",{"date":69,"type":40},"2011-02-09",{"name":44,"class":45},{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":4,"eligibilityCriteria":77,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":81,"phases":82,"briefSummary":84,"conditions":85,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":89,"completionDateStruct":91,"leadSponsor":93,"locationsCount":96},"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.","18 Years",{"count":80,"type":22},211,"INTERVENTIONAL",[83],"PHASE3","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.",[26,27],"2026-05-14",{"date":88,"type":40},"2026-05-15",{"date":90,"type":40},"2025-01-22",{"date":92,"type":22},"2027-11-25",{"name":94,"class":95},"Pfizer","INDUSTRY",24,{"id":98,"slug":99,"hasResults":11,"nctId":100,"briefTitle":101,"officialTitle":101,"acronym":4,"eligibilityCriteria":102,"healthyVolunteers":16,"sex":17,"minAge":78,"maxAge":103,"enrollmentInfo":104,"targetDuration":106,"studyType":23,"phases":4,"briefSummary":107,"conditions":108,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":127,"lastUpdatePostDateStruct":128,"startDateStruct":130,"completionDateStruct":132,"leadSponsor":134,"locationsCount":137},"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":105,"type":22},5000,"10 Years","To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.",[109,110,111,112,113,114,115,116,26,27,117,118,119,120,121,122,123,124,125,126],"Rheumatic Diseases","Adult Onset Still Disease","Ankylosing Spondylitis","Psoriatic Arthritis","Reactive Arthritis","Antiphospholipid Syndrome","Systemic Lupus Erythematosus","Behcet Disease","Giant Cell Arteritis","Lyme Disease","Mixed Connective Tissue Disease","Polymyalgia Rheumatica","Rheumatoid Arthritis","Sarcoidosis","Systemic Sclerosis","Scleroderma","Sjogren's Syndrome","Undifferentiated Connective Tissue Diseases","2026-02-11",{"date":129,"type":40},"2026-02-13",{"date":131,"type":40},"2020-08-04",{"date":133,"type":22},"2030-06-01",{"name":135,"class":136},"Yale University","OTHER",1,{"id":139,"slug":140,"hasResults":11,"nctId":141,"briefTitle":142,"officialTitle":143,"acronym":144,"eligibilityCriteria":145,"healthyVolunteers":11,"sex":17,"minAge":146,"maxAge":4,"enrollmentInfo":147,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":149,"conditions":150,"keywords":158,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":168,"lastUpdatePostDateStruct":169,"startDateStruct":171,"completionDateStruct":173,"leadSponsor":175,"locationsCount":137},"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":148,"type":22},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",[151,152,34,153,26,154,155,156,27,28,157,58],"IBM","IIM","Inflammatory Myopathy","Dermatomyositis, Juvenile","Anti-synthetase Syndrome","Immune-Mediated Necrotizing Myopathy","Juvenile Myositis",[159,160,161,162,163,164,165,166,167],"myositis","rare diseases","patient priorities","patient engagement","patient initiated","patient research partners","qualitative research","mixed methods research","research priorities","2026-01-20",{"date":170,"type":40},"2026-01-28",{"date":172,"type":40},"2025-06-25",{"date":174,"type":22},"2030-12",{"name":176,"class":136},"Myositis International Health & Research Collaborative Alliance Foundation",{"id":178,"slug":179,"hasResults":11,"nctId":180,"briefTitle":181,"officialTitle":181,"acronym":182,"eligibilityCriteria":183,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":4,"enrollmentInfo":184,"targetDuration":4,"studyType":81,"phases":185,"briefSummary":188,"conditions":189,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":190,"lastUpdatePostDateStruct":191,"startDateStruct":193,"completionDateStruct":195,"leadSponsor":197,"locationsCount":137},"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":96,"type":22},[186,187],"PHASE1","PHASE2","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.",[115,123,26,27],"2025-09-24",{"date":192,"type":40},"2025-09-30",{"date":194,"type":40},"2023-07-17",{"date":196,"type":22},"2026-05-31",{"name":198,"class":95},"Miltenyi Biomedicine GmbH",{"id":200,"slug":201,"hasResults":11,"nctId":202,"briefTitle":203,"officialTitle":204,"acronym":4,"eligibilityCriteria":205,"healthyVolunteers":11,"sex":17,"minAge":206,"maxAge":4,"enrollmentInfo":207,"targetDuration":4,"studyType":81,"phases":209,"briefSummary":210,"conditions":211,"keywords":212,"overallStatus":214,"whyStopped":4,"lastUpdateSubmitDate":215,"lastUpdatePostDateStruct":216,"startDateStruct":218,"completionDateStruct":220,"leadSponsor":222,"locationsCount":224},"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":208,"type":22},36,[187],"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",[27,26],[213],"mitochondria","NOT_YET_RECRUITING","2025-08-07",{"date":217,"type":40},"2025-08-14",{"date":219,"type":22},"2025-12",{"date":221,"type":22},"2027-04",{"name":223,"class":95},"Paean Biotechnology Inc.",5,{"id":226,"slug":227,"hasResults":11,"nctId":228,"briefTitle":229,"officialTitle":229,"acronym":230,"eligibilityCriteria":231,"healthyVolunteers":11,"sex":17,"minAge":78,"maxAge":232,"enrollmentInfo":233,"targetDuration":4,"studyType":81,"phases":234,"briefSummary":235,"conditions":236,"keywords":4,"overallStatus":36,"whyStopped":4,"lastUpdateSubmitDate":240,"lastUpdatePostDateStruct":241,"startDateStruct":243,"completionDateStruct":245,"leadSponsor":246,"locationsCount":137},"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).","65 Years",{"count":5,"type":22},[186,187],"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.",[237,238,239,26,27],"Lupus Erythematosus, Systemic","System; Sclerosis","ANCA Associated Vasculitis","2025-04-10",{"date":242,"type":40},"2025-04-11",{"date":244,"type":40},"2024-11-29",{"date":219,"type":22},{"name":247,"class":136},"Fondazione Policlinico Universitario Agostino Gemelli IRCCS"]