[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"sjogrens-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:sjogrens-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":7,"results":8},null,33,0,25,[9,47,81,102,125,153,180,206,228,265,289,309,346,376,395,418,455,477,508,533,558,584,603,623,649],{"id":10,"slug":11,"hasResults":12,"nctId":13,"briefTitle":14,"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":34,"whyStopped":4,"lastUpdateSubmitDate":35,"lastUpdatePostDateStruct":36,"startDateStruct":39,"completionDateStruct":41,"leadSponsor":43,"locationsCount":46},"100234290","characterization-of-diseases-with-salivary-gland-involvement-100234290",false,"NCT02327884","Characterization of Diseases With Salivary Gland Involvement","* INCLUSION CRITERIA:\n* Persons older than 4 years of age, affected with or suspected of being affected with a disease\u002Fdisorder involving the salivary glands or who is a relative of a person who is affected with these diseases\u002Fdisorders.\n\nOr,\n\n\\- Persons 18 years or older with active hepatitis with or without sicca symptoms and patients undergoing immunotherapy with an immune checkpoint inhibitor for oral cancer.\n\nSpecific to patients undergoing immunotherapy with an immune checkpoint inhibitor for threatment of oral cancer, these patients will be seen before and after check point inhibitor therapy which will coincide with 4 weeks (+\u002F-2 weeks) before and again immediately before (+\u002F- 2 weeks) definitive oral cancer treatment initiation (e.g., surgical resection, etc.).\n\nOr,\n\n\\- Healthy persons age 18 or older, who agree to have blood, urine, saliva or tissue samples collected and studied.\n\nEXCLUSION CRITERIA:\n\n* Anyone not able to give consent\u002Fassent or parental\u002Fguardian consent\n* NIH employees who report directly to the principal investigator\n* Significant concurrent medical condition or other circumstances that may affect the participant s ability to tolerate or complete the study, such as concurrent chemotherapy or bleeding disorders.\n\n  * Specific only to the immune checkpoint inhibitor patients, oral cancer as a serious concurrent medical condition, will not serve as an exclusion criteria.\n  * Moreover, these immune checkpoint inhibitor subjects, if unable to tolerate the study procedures, such as salivary gland biopsies, saliva collections, and\u002For oral exams, will be excluded as determined by the Principal Investigator.\n* Additional exclusion criteria for Healthy Volunteers (HV):\n\n  * Pregnancy\n  * Sicca Symptoms\n  * HIV, hepatitis B or C infection\n  * Chronic medical illness, other than well-controlled hypertension or hyperlipidemia\n  * Chronic use of medications, with the exception of oral contraception, hormone replacement therapy, aspirin, antihypertensives and antilipemics",true,"ALL","4 Years","100 Years",{"count":21,"type":22},1150,"ESTIMATED","OBSERVATIONAL","Background:\n\n\\- Salivary glands in and around the mouth and throat make saliva. Salivary gland disorders can affect a person s quality of life. Studying people who have a disease that affects their salivary gland(s) may teach researchers about the disorders and their genetics.\n\nObjectives:\n\n\\- To study salivary gland diseases and disorders. To collect data and samples from people with salivary gland problems and their relatives.\n\nEligibility:\n\n* People more than 4 years old who have or are suspected to have a disease involving salivary glands.\n* Their relatives more than 4 years old.\n* Healthy volunteers 18 years or older.\n\nDesign:\n\n* Participants may be screened with:\n* Medical history\n* Physical exam\n* Blood and urine tests\n* General oral and dental history and exam\n* Saliva collection\n* Eye exam and test for dry eyes\n* Health questionnaires (adults)\n* Biopsy of some minor salivary glands. A small incision will be made on the inside of the lower lip and several tiny salivary glands will be removed.\n* Participants will have 2-3 visits. These may include:\n* Repeats of some screening tests\n* Ultrasounds of some glands. Researchers will put some gel on the face, then press on it with a smooth wand.\n* Adults may have other biopsies\n* A small catheter inserted into the opening of the parotid gland duct on the inside of the cheek. A saline solution (in a syringe) will fill the duct.\n* Swishing a saltwater solution in the mouth for 10 seconds and then spitting into a cup\n* Scrapings collected from teeth, tongue, and cheeks",[26,27,28],"Healthy Volunteer","Sjogren's Syndrome","Salivary Gland Disease",[30,31,27,32,33],"Genetics","Dry Mouth","Gland dysfunction","Induced Pluripotent Stem (iPS) Cell Lines","RECRUITING","2026-06-27",{"date":37,"type":38},"2026-06-30","ACTUAL",{"date":40,"type":38},"2015-04-03",{"date":42,"type":22},"2032-04-01",{"name":44,"class":45},"National Institute of Dental and Craniofacial Research (NIDCR)","NIH",1,{"id":48,"slug":49,"hasResults":12,"nctId":50,"briefTitle":51,"officialTitle":52,"acronym":4,"eligibilityCriteria":53,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":55,"enrollmentInfo":56,"targetDuration":4,"studyType":58,"phases":59,"briefSummary":61,"conditions":62,"keywords":63,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":46},"100614581","phase-2-safety-of-tofacitinib-an-oral-janus-kinase-inhibitor-in-primary-sjogren-disease-100614581","NCT07281456","Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren Disease","Safety of Tofacitinib, an Oral Janus Kinase Inhibitor, in Primary Sjogren's Disease Phase IIa Open-Label Clinical Trial and Associated Mechanistic Studies","* INCLUSION CRITERIA:\n\nAdult SjD participants with mild-to-moderate disease activity will be eligible for this study. Enrolled participants can be naive or have failed immunosuppressive therapy beyond antimalarials and glucocorticoids, to prevent bias in the cohort of participants with more recalcitrant disease. We expect that Tofacitinib is a potential second-line therapy, in addition to antimalarials and glucocorticoids, depending on the participant's initial presentation and response. Women and members of minority groups, if eligible, will be included in accordance with the NIH Policy on Inclusion of Women and Minorities as Participants in Research Involving Human Participants.\n\nAdditionally, 20-D-0131(Safety of Tofacitinib, an oral Janus Kinase Inhibitor, in primary Sjogren's syndrome Phase Ib-IIa placebo-controlled clinical trial and associated mechanistic studies) participants who, at unblinding, received a placebo will be contacted and asked to return to the study to participate in this study.\n\nTo be eligible to participate in this study, an individual must meet all of the following criteria:\n\n1. Ability of participant to understand and the willingness to sign a written informed consent document.\n2. Participation and enrollment in companion protocol, 15-D-0051, Characterization of Diseases with Salivary Gland Involvement.\n3. Stated willingness to comply with all study procedures and availability for the duration of the study\n4. Male or female, aged between 18-75 years old\n5. In good general health as evidenced by medical history\n6. Meets the 2002 American European Consensus Group classification criteria for Sjogren's disease or 2016 American College of Rheumatology\u002FEuropean League against Rheumatism Classification Criteria (ACR-EULAR) with mild to moderate disease activity defined as ESSDAI between 0 and 13 at the screening visit and \\>0 ml\u002Fmin\u002Fgland stimulated saliva flow.\n7. Ability to take oral medication and be willing to adhere to the study intervention regimen\n8. If on glucocorticoids, the dose must be less than 10 mg daily and stable for the 4 weeks (28 days) prior to the screening visit.\n9. If on hydroxychloroquine or other antimalarials such as chloroquine or quinacrine, the dose must have been stable for the 12 weeks (96 days) prior to screening visit. The maximum allowed dose is hydroxychloroquine up to 400 mg\u002Fday or 6.5 mg\u002Fkg\u002Fday if more than 400 mg\u002Fday. The maximum allowed dose for chloroquine phosphate is up to 500 mg daily and for quinacrine up to 100 mg daily.\n10. Participants may be on lipid lowering medications if initiated at least 3 months prior to the screening visit and dose must be stable for 4 weeks (28 days) prior to study entry.\n11. Males and females with potential for reproduction must agree to practice effective birth control measures. Females should be on adequate contraception if they are of child-bearing potential documented by a clinician, unless participants or spouse have previously undergone a sterilization procedure. Adequate birth control measures are: intrauterine device (IUD) alone or hormone implants, hormone patches, injectable, or oral contraceptives plus a barrier method (male condom, female condom or diaphragm), abstinence or a vasectomized partner.\n12. Agreement to adhere to Lifestyle Considerations throughout study duration\n\nEXCLUSION CRITERIA:\n\nTo be eligible to participate in this study, an individual must not meet any of the following criteria:\n\n1. Current or prior treatment with rituximab, belimumab, or any other biologic agent in the 6 months prior to screening.\n2. Current or prior treatment with Tofacitinib for more than 6 months in the last 2 years prior to screening.\n3. Current treatment with methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, tacrolimus, or other less common immunomodulatory drugs such as those falling into the class of disease-modifying antirheumatic drugs (DMARDs), not otherwise specified herein. Participants previously on methotrexate, azathioprine, mycophenolate mofetil, cyclosporine or tacrolimus, or other DMARDs should have withdrawn drug for at least 8 weeks (56 days) at the time of screening. The use of topical or ophthalmic preparations of cyclosporine, tacrolimus, or other DMARDs is permitted and does not require an 8-week withdrawal period.\n4. Treatment with cyclophosphamide, pulse methylprednisolone or IVIG within 6 months prior to screening.\n5. Current treatment with potent inhibitors of Cytochrome P450 3A4 (CYP3A4) (e.g., ketoconazole) or receiving one or more concomitant medications that result in both moderate inhibition of CYP3A4 and potent inhibition of CYP2C19 (e.g., fluconazole) that would increase serum availability of Tofacitinib. Past treatment with the agent is allowed if it was more than a week prior to the administration of the first dose of study medication.\n6. History of chronic liver disease, not including well-controlled Sjogren's-related chronic liver disease or elevated LFTs:\n\n   * ALT or AST \\>= 2x upper limit of normal at screening\n   * Serum unconjugated bilirubin \\> 2mg\u002FdL at screening\n7. Serum creatinine \\>1.5mg\u002FdL.\n8. Protein to creatinine ratio of more than 1mg\u002FdL at screening (repeated and confirmed three times or confirmed with 24 hours urine protein of more than 1000mg).\n9. Active urinary sediment (WBC, RBC or mixed cellular casts 1+ or more \u002Fhpf).\n10. Hypercholesterolemia: Values after 8-12 hour fasting blood specimen: total cholesterol \\>250 mg\u002FdL or LDL \\>180 mg\u002FdL or hypertriglyceridemia (triglyceride \\>300 mg\u002FdL) within - 45 days of screening visit.\n11. WBC \\\u003C2500\u002FmicroL or ANC \\\u003C1,000\u002FmicroL, Hgb \\\u003C9.0 g\u002FdL or platelets \\\u003C70,000\u002FmicroL or absolute lymphocyte count \\\u003C 500\u002FmicroL.\n12. Pregnant or lactating women. Women of childbearing potential are required to have a negative pregnancy test at screening.\n13. A history of drug or alcohol abuse within the 6 months prior to screening.\n14. Currently receiving hemodialysis, peritoneal dialysis, or intestinal dialysis.\n15. Active infection that requires the use of oral or intravenous antibiotics unresolved at least 14 days prior to the administration of the first dose of study medication.\n16. Active chronic infections including but not limited to HIV, Hepatitis B, Hepatitis C, and BK viremia at screening visit.\n17. Current or previous diagnosis of malignant disease, except for basal cell or squamous cell carcinoma of the skin with complete excision and clear borders or adequately treated in situ carcinoma of the cervix.\n18. Known active tuberculosis. Participants with treated latent tuberculosis (LTB) will be eligible to participate. Participants with untreated LTB will not be excluded but will be evaluated by an infectious disease (I.D.) consultant and may become eligible for trial based on infectious disease consultant recommendations.\n19. History of severe or systemic infections caused by common pathogens, or history of infection with pathogens that do not normally cause human disease.\n20. Participants with active renal or central nervous system disease or a high activity level in any organ system (except articular) in ESSDAI54.\n21. Participants with known increased risk factors for major adverse cardiac event (MACE) including a history of:\n\n    * Ischemic heart disease (e.g., history of acute myocardial infarction)\n    * Heart failure\n    * Cardiomyopathy\n    * Severe valvular heart disease\n    * Significant arrhythmias\n    * Chronic renal failure\n    * Cerebrovascular accident or transient ischemic attack\n    * Uncontrolled diabetes mellitus\n    * Uncontrolled hypertension\n    * Current smokers or former smokers with less than 3 years since complete cessation and\u002For \\>20 pack-years of smoking history.\n22. Significant impairment of major organ function (lung, heart, liver, kidney) or any condition that, in the opinion of the Investigator, would jeopardize the participant's safety following exposure to the Tofacitinib.\n23. Known history of arterial or venous thrombosis or at high risk for clotting disorder\n24. Psychiatric illness or history of medical non-compliance that the study team feels will make the patient unlikely to complete the study\n25. Uncontrolled thyroid disease as determined by PI or medically responsible investigator.\n26. Known allergic reactions to Tofacitinib or its components\n27. Treatment with another investigational drug\u002Fintervention within six months except for COVID-19 vaccines or therapies that have been granted an FDA emergency authorization.","18 Years","75 Years",{"count":57,"type":22},60,"INTERVENTIONAL",[60],"PHASE2","Background:\n\nSjogren disease is an autoimmune disease - that is, a disease that causes the body's immune system to attack its own organs and tissues. Sjogren disease can affect the kidneys, lungs, or other organs. It can also cause dry mouth and eyes, fever, joint pain, rashes, and other symptoms. Researchers want to know if a drug approved to treat rheumatoid arthritis and other autoimmune diseases can help people with Sjogren disease.\n\nObjective:\n\nTo test a drug (tofacitinib) in people with Sjogren disease.\n\nEligibility:\n\nPeople aged 18 to 75 years with Sjogren disease. They must be enrolled in protocol 15-D-0051.\n\nDesign:\n\n* Participants will be screened. They will have a physical exam with blood and urine tests. They will give samples of saliva; a small sample of tissue will be taken from a salivary gland. They will have a test of their heart function. They will have an eye exam, including a test for dry eyes.\n* Tofacitinib is a tablet taken by mouth. Participants will take the drug twice a day at home.\n* Participants will have 9 clinic visits over 28 weeks. Each visit will take up to 5 hours. In addition to repeated tests, they will have tests of the speed and pressure of blood flow through their body. They will complete health questionnaires throughout the study.\n* Participants will also have 5 phone visits during the study. They will review their health and study treatments.\n* They will have 1 final visit after they stop taking the drug.",[27],[64,31,65,66,67,68,69,70,71,72],"Salivary","Safety","Inflammation","Xerostomia","Jak","Autoimmune","Xerophthalmia","Lacrimal","Exocrine","2026-06-25",{"date":75,"type":38},"2026-06-26",{"date":77,"type":38},"2025-12-18",{"date":79,"type":22},"2030-12-15",{"name":44,"class":45},{"id":82,"slug":83,"hasResults":12,"nctId":84,"briefTitle":85,"officialTitle":85,"acronym":86,"eligibilityCriteria":87,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":88,"targetDuration":4,"studyType":58,"phases":90,"briefSummary":92,"conditions":93,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":94,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":46},"100433979","b-dependant-rare-autoimmune-diseases---cohort-of-patients-with-suspected-diagnosis-of-primitive-sjgren-syndrome-100433979","NCT04931160","B-dependant Rare AutoImmune diseaSES - Cohort of Patients With Suspected Diagnosis of Primitive Sjögren Syndrome","BRAISES-DiaPSS","Inclusion Criteria:\n\n* Major patient\n* Suspicion of SSp (clinical or biological criteria, i.e. dry eye or oral syndrome, arthritis, parotidomegaly, neuropathy, kidney or lung disease...)\n* Patient affiliated with Social Security\n* Patient who has signed written informed consent\n\nExclusion Criteria:\n\n* Refusal to participate\n* Pregnant and lactating woman",{"count":89,"type":22},1000,[91],"NA","The objectif is to study the diagnosis performance of the different classification criteria in reference to the gold standard consisting of the diagnosis made by expert doctors after standardized assessment, of pSS (primary Sjogren syndrome)",[27],{"date":75,"type":38},{"date":96,"type":38},"2020-02-10",{"date":98,"type":22},"2035-02-10",{"name":100,"class":101},"University Hospital, Brest","OTHER",{"id":103,"slug":104,"hasResults":12,"nctId":105,"briefTitle":106,"officialTitle":106,"acronym":4,"eligibilityCriteria":107,"healthyVolunteers":12,"sex":17,"minAge":108,"maxAge":19,"enrollmentInfo":109,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":111,"conditions":112,"keywords":115,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":119,"lastUpdatePostDateStruct":120,"startDateStruct":122,"completionDateStruct":4,"leadSponsor":124,"locationsCount":46},"100165376","the-pathogenesis-and-natural-history-of-sjogrens-disease-100165376","NCT01425892","The Pathogenesis and Natural History of Sjogren's Disease","* INCLUSION CRITERIA:\n\n  1. Ability to sign informed consent form\n  2. Fulfilling one the definitions below:\n\n     1. Sjogren s defined by European-American (EA) classification criteria for primary or secondary Sjogren s Disease (SjD group)\n     2. Excluded from the EA criteria because of a comorbid condition but otherwise fulfilling the European-American classification criteria (EA excluded SjD group)\n     3. Incomplete SjD\n\n     i. at least 2 of the EA criteria with a common manifestation of SjD not included in these criteria (e.g., fatigue, vasculitis, arthritis, etc) or\n\n     ii. 2 or more common manifestations of SjD which are not included in the EA criteria (e.g.,: fatigue, vasculitis, arthritis, autonomic dysfunction, etc ) and are not explained by other conditions\n\n     EXCLUSION CRITERIA:\n\n  \u003C!-- -->\n\n  1. Age \\\u003C16 years\n  2. inability or unwillingness to comply with follow up requirements\n  3. Any medical or psychological\u002Fpsychiatric condition or treatment that, in the opinion of the Principal Investigator, would exclude the subjects from the research studies (e.g., alternative explanation for subjects signs and symptoms)\n  4. NIH employees who report directly to the principal investigator or who are a co-worker or relative of the principal investigator.","16 Years",{"count":110,"type":22},300,"Background:\n\n-Sjogren s Disease (formerly: Sjogrens Syndrome, Sj(SqrRoot)(Delta)gren s syndrome) is a disease that affects about 1-4 million Americans. It is more common in women. It mainly affects the glands that produce saliva and tears, leading to dry eyes and dry mouth. The cause of Sjogren s Disease is unknown, but inflammation plays an important role. The purpose of this study is to learn more about Sjogren s Disease.\n\nObjectives:\n\n-To better understand how Sjogren s Disease begins and how it affects patients so that we can develop better ways to treat them.\n\nEligibility:\n\n* Participants must be 16 years of age or older.\n* They must have a diagnosis of Sjogren s Disease or have at least two symptoms of Sjogren s Disease.\n\nDesign:\n\n* People taking part in the study will come to the NIH Clinical Center for at least three visits.\n* During these visits, participants will have a medical history and physical exam. They will have oral and dental assessments, and saliva collection. Lab tests (blood and urine) and dry eye exams will be done. Participants will answer questionnaires and have salivary scintigraphy (adults only unless required for diagnosis).\n* Other optional tests may also be done. Participants may have to come in for additional visits if they have these optional tests or if their disease changes.\n* The only treatment provided as part of this study is for medical emergencies or complications that occur while you are at NIH for evaluation.",[27,113,114],"Salivary Gland","Pathogenesis",[27,113,114,116,117,118],"Natural History","Sj(SqrRoot)(Delta)gren s syndrome","Sjogrens Syndrome","2026-06-17",{"date":121,"type":38},"2026-06-18",{"date":123,"type":38},"2012-01-18",{"name":44,"class":45},{"id":126,"slug":127,"hasResults":12,"nctId":128,"briefTitle":129,"officialTitle":130,"acronym":4,"eligibilityCriteria":131,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":132,"targetDuration":4,"studyType":58,"phases":134,"briefSummary":136,"conditions":137,"keywords":140,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":142,"lastUpdatePostDateStruct":143,"startDateStruct":145,"completionDateStruct":147,"leadSponsor":149,"locationsCount":152},"100596103","phase-1-a-study-of-cln-978-a-subcutaneously-administered-cd19-directed-t-cell-engager-in-subjects-with-sjogrens-disease-100596103","NCT07041099","A Study of CLN-978, a Subcutaneously Administered CD19-directed T Cell Engager, in Subjects With Sjogren's Disease","A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease","Inclusion\n\n* Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR \u002F ACR Classification Criteria for SjD at Screening.\n* Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening.\n* Laboratory parameters including the following:\n\n  * Absolute lymphocyte count (ALC) ≥0.5 × 10\\^9\u002FL\n  * Peripheral CD19+ B cell count ≥25 cells\u002FµL\n  * Absolute neutrophil count (ANC) ≥1.0 × 10\\^9\u002FL\n  * Hemoglobin (Hgb) ≥8 g\u002FdL\n  * Platelet count ≥75 × 10\\^9\u002FL\n  * Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome\n  * Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 × ULN\n  * Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥30 mL\u002Fmin\u002F1.73 m2\n\nExclusion\n\n* Concomitant rheumatological autoimmune disease\n* Considered at high risk for thrombosis\n* Rapidly progressive glomerulonephritis and\u002For urine protein\u002Fcreatinine \\>3 mg\u002Fmg (339 mg\u002Fmmol).\n* Active, severe central nervous system manifestations of SjD.\n* History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder that the Investigator feels would put the patient at undue risk or confound study results.\n* Evidence of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.\n* Primary immunodeficiency or history of recurrent infections.\n* History of splenectomy.\n* Live or attenuated vaccine within 28 days prior to the Screening Visit or during the Screening Period.\n* Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, within 14 days prior to Day 1.\n* Active or latent tuberculosis (TB)",{"count":133,"type":22},36,[135],"PHASE1","A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.",[138,139,27],"Sjögren","Sjogren Disease",[141],"CLN-978","2026-03-20",{"date":144,"type":38},"2026-03-23",{"date":146,"type":38},"2025-10-01",{"date":148,"type":22},"2029-03-15",{"name":150,"class":151},"Cullinan Therapeutics Inc.","INDUSTRY",11,{"id":154,"slug":155,"hasResults":12,"nctId":156,"briefTitle":157,"officialTitle":157,"acronym":4,"eligibilityCriteria":158,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":159,"enrollmentInfo":160,"targetDuration":4,"studyType":58,"phases":162,"briefSummary":164,"conditions":165,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":46},"100558245","early-phase-1-clinical-study-on-targeted-cd19-or-cd19-bcma-car-t-therapy-for-autoimmune-diseases-100558245","NCT06548607","Clinical Study on Targeted CD19 or CD19-BCMA CAR-T Therapy for Autoimmune Diseases","Inclusion Criteria:\n\n1. The subjects voluntarily participated in the study and signed the informed consent form.\n2. Age ≥18 years old and ≤70 years old, both sexes.\n3. Organ function and laboratory tests:\n\n   1. Liver function: alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3× upper limit of normal (ULN), total bilirubin (TBIL) ≤2×ULN (except Gilbert's syndrome).\n   2. Renal function: creatinine ≤1.5×ULN or creatinine clearance ≥40 ml\u002Fmin.\n   3. Blood routine: neutrophil count ≥1×10\\^9\u002FL, hemoglobin ≥60g\u002FL, platelet count ≥20×10\\^9\u002FL, lymphocyte count \\>0.3×10\\^9\u002FL.\n   4. Coagulation: international normalized ratio (INR) ≤ 1.5×ULN, or prothrombin time (PT) ≤ 1.5×ULN.\n   5. Oxygen saturation (SpO2) ≥92% at rest in room air.\n   6. Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.\n4. Negative serum or urine pregnancy test results in female subjects of childbearing potential at screening.\n5. Women of childbearing potential must agree to use a highly effective method of contraception for at least 28 days before initiation of elution and up to 12 months after CAR-T reinfusion. Men of childbearing potential had to agree to the use of an effective barrier method of contraception from the initiation of lymphoidectomy until 12 months after reinfusion of CAR-T and had to refrain from donating semen or sperm throughout the trial.\n\nSLE Patient Inclusion Criteria:\n\n1. A definitive diagnosis of SLE according to the 2019 European League Against Rheumatism (EULAR) \u002F American College of Rheumatology (ACR) classification criteria or the 2012 Systemic Lupus International Collaborating Clinics (SLICC) criteria.\n2. Positive antinuclear antibodies (ANA) at screening, and\u002For positive anti-double-stranded DNA (anti-dsDNA) antibodies, and\u002For positive anti-Smith antibodies.\n3. A SLEDAI-2K score \\>6 at screening, and a 'clinical' SLEDAI-2K score ≥4.\n\nSSc Patient Inclusion Criteria:\n\n1. Diagnosed with SSc according to the 2013 ACR\u002FEULAR classification criteria.\n2. Diagnosed with diffuse cutaneous SSc at screening, with a disease duration ≤6 years.\n\nAAV Patient Inclusion Criteria:\n\n1. Meeting the diagnostic criteria for ANCA-associated vasculitis established by the 2022 ACR\u002FEULAR, including Microscopic Polyangiitis (MPA), Granulomatosis with Polyangiitis (GPA), and Eosinophilic Granulomatosis with Polyangiitis (EGPA).\n2. Positive testing for ANCA-associated antibodies 3 months before screening or at screening (specifically, positive anti-myeloperoxidase antibodies, MPO-ANCA, or positive anti-proteinase 3 antibodies, PR3-ANCA).\n\nIIM Patients Inclusion Criteria:\n\n1. Diagnosed with IIM according to the 2017 ACR\u002FEULAR classification criteria (including probable or definite diagnosis, i.e., probability ≥55%), including subtypes such as Dermatomyositis (DM), Anti-Synthetase Syndrome (ASS), and Immune-Mediated Necrotizing Myopathy (IMNM).\n2. Patients in the active phase, defined as those with at least 2 of the following six core set measures being abnormal: decreased muscle strength (MMT-8 \\\u003C142), Physician Global Assessment (PhGA, 10cm VAS) ≥2cm, Patient Global Assessment (PtGA, 10cm VAS) ≥2cm, Extramuscular Disease Activity Total Score (assessed using the MDAAT scoring tool) ≥2cm, Health Assessment Questionnaire (HAQ) ≥0.25, and Creatine Kinase (CK) muscle enzyme levels ≥1.5×ULN\n\nSjögren's Syndrome (SS) Patient Inclusion Criteria:\n\n1. Diagnosed with primary Sjögren's Syndrome according to the 2016 ACR\u002FEULAR classification criteria.\n2. Positive for anti-SSA\u002FRo antibodies detected 3 months before screening or at screening.\n3. A score of ≥5 on the European League Against Rheumatism Sjögren's Syndrome Disease Activity Index (ESSDAI) at screening.\n\nExclusion Criteria:\n\n1. SLE Patients: Those with uncontrolled lupus crisis within the 8 weeks prior to screening, including rapidly progressive lupus nephritis, severe neuropsychiatric lupus, severe hemolytic anemia, severe immune thrombocytopenia, agranulocytosis, severe cardiac damage, severe lupus pneumonia, severe lupus hepatitis, and severe vasculitis, as assessed by the investigator as unsuitable to participate in this study.\n2. IIM Patients: Presence of severe rhabdomyolysis or CK levels ≥120×ULN at screening.\n3. Patients with severe asthma or Chronic Obstructive Pulmonary Disease (COPD) are eligible. Patients with mild or moderate asthma or COPD who are receiving stable treatment can also be enrolled.\n4. There has been an active infection requiring systemic treatment within 2 weeks prior to the urethral irrigation, such as infectious pneumonia, tuberculosis, etc.\n5. Positive for hepatitis B surface antigen (HBsAg), or positive for hepatitis B core antibody (HBcAb) with detectable hepatitis B virus (HBV) DNA in peripheral blood; positive for hepatitis C virus (HCV) antibody with detectable HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.\n6. Pregnant or breastfeeding women.\n7. Any condition that, in the investigator's opinion, may affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.","70 Years",{"count":161,"type":22},20,[163],"EARLY_PHASE1","This is an open clinical pharmacological translational Research Study, aiming to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of CD19 or CD19-BCMA CAR-T in patients with active SLE, SSc, AAV, IIM and pSS.",[166,167,168,169,27,170],"SLE (Systemic Lupus)","Systemic Sclerosis","ANCA Associated Vasculitis","Idiopathic Inflammatory Myopathies","Autoimmune Diseases","2026-03-04",{"date":173,"type":38},"2026-03-06",{"date":175,"type":38},"2024-09-14",{"date":177,"type":22},"2027-12-31",{"name":179,"class":151},"Nanjing Bioheng Biotech Co., Ltd.",{"id":181,"slug":182,"hasResults":12,"nctId":183,"briefTitle":184,"officialTitle":185,"acronym":4,"eligibilityCriteria":186,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":187,"enrollmentInfo":188,"targetDuration":4,"studyType":58,"phases":190,"briefSummary":191,"conditions":192,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":198,"lastUpdatePostDateStruct":199,"startDateStruct":200,"completionDateStruct":202,"leadSponsor":204,"locationsCount":46},"100611144","phase-1-an-exploratory-clinical-study-of-yts109-cell-for-rr-autoimmune-diseases-100611144","NCT07236762","An Exploratory Clinical Study of YTS109 Cell for R\u002FR Autoimmune Diseases","An Exploratory Clinical Study on the Safety and Efficacy of YTS109 Cell in Subjects With Relapsing\u002FRefractory Autoimmune Diseases","Inclusion Criteria:\n\n* Subjects must meet both the following common inclusion criteria and disease-specific inclusion criteria simultaneously to be eligible for participation in this study:\n\nCommon inclusion criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Essential Organ Function Criteria:\n\n\u003C!-- -->\n\n1. Bone marrow: Neutrophils ≥1×10\\^9\u002FL (within 2 weeks, excluding granulocyte colony-stimulating factor use); Hemoglobin ≥60 g\u002FL.\n2. Liver: ALT\u002FAST ≤3×ULN (disease-related elevations permitted). TBIL≤1.5×ULN (disease-related elevations permitted).\n3. Renal: CrCl≥30mL\u002Fmin (Cockcroft-Gault formula, excluding acute declines).\n4. Coagulation: INR\u002FPT ≤1.5×ULN.\n5. Cardiovascular: Hemodynamic stability. 3. Fertile females or males with partners of childbearing age must use medically approved contraception or abstain during and ≥12 months post- treatment. Negative serum HCG test (within 7 days pre-enrollment) for fertile females; non-lactating.\n\n4\\. Voluntary participation with signed informed consent and compliance.\n\nSpecific inclusion criteria:\n\nRelapsing and refractory systemic lupus erythematosus:\n\n1. Meeting the 2019 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for systemic lupus erythematosus (SLE);\n2. Meeting the criteria for refractory lupus nephritis (LN) or SLE-associated immune thrombocytopenia (SLE-ITP), defined as follows:\n\n\u003C!-- -->\n\n1. Refractory Lupus Nephritis:\n\n   1. Failure to achieve remission following treatment regimens comprising glucocorticoids and at least two immunosuppressive agents (including cyclophosphamide \\[CTX\\], tacrolimus, mycophenolate mofetil \\[MMF\\], and cyclosporine) and\u002For biologic agents (including rituximab, belimumab, telitacicept, etc.).\n   2. Urine protein-to-creatinine ratio (UPCR) ≥1.0 g\u002Fg or 24-hour urine protein excretion \\>1.0 g at screening.\n   3. Renal pathology must be performed within 6 months prior to the screening visit or during the screening period, demonstrating proliferative lupus nephritis (Class III or IV, with or without Class V) according to the 2003 International Society of Nephrology\u002FRenal Pathology Society (ISN\u002FRPS) criteria, with ≤50% glomerular sclerosis noted in the pathology report.\n2. Refractory SLE-Associated Immune Thrombocytopenia:\n\n   1. Failure to achieve partial remission after at least one course of methylprednisolone pulse therapy (0.5-1 g × 3-5 days) or high-dose glucocorticoids (equivalent to 1 mg\u002Fkg\u002Fday of prednisone) combined with one or more immunosuppressive agents (including biologic agents) for at least 3 months, or inability to maintain therapeutic efficacy during glucocorticoid tapering. Platelet count \\\u003C50 × 10⁹\u002FL on at least two consecutive complete blood count tests prior to enrollment. Exclusion of thrombocytopenia due to non-SLE causes, such as infection, bone marrow suppression, or hypersplenism.\n\n      Relapsing and refractory Sjögren's syndrome:\n      1. Meeting the 2002 American-European Consensus Group (AECG) criteria or the 2016 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) classification criteria for primary Sjögren's syndrome;\n      2. Having a disease activity score of EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) ≥ 6;\n      3. Testing positive for anti-SSA\u002FRo antibodies;\n      4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids in combination with any of the following immunosuppressive agents or biological agents: cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\n         Relapsing and refractory Sjogren's Syndrome:\n\n      \u003C!-- -->\n\n      1. Meeting the 2013 American College of Rheumatology (ACR) classification criteria for systemic sclerosis;\n      2. Testing positive for systemic sclerosis-related antibodies;\n      3. Presenting with diffuse cutaneous sclerosis or active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n      4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n      5. Definition of progressive condition: Demonstrating rapid skin progression (an increase in modified Rodnan skin score, mRSS, of \\>25%) or pulmonary disease progression (a 10% decrease in forced vital capacity, FVC, or a \\>5% decrease in FVC accompanied by a 15% decrease in diffusion capacity for carbon monoxide, DLCO).\n\n      Note: Meeting either criterion 4 or 5 is sufficient.\n\n      Relapsing and refractory Inflammatory Myopathy:\n      1. Meeting the 2017 European League Against Rheumatism\u002FAmerican College of Rheumatology (EULAR\u002FACR) classification criteria for inflammatory myopathies (including dermatomyositis, DM; polymyositis, PM; antisynthetase syndrome, ASS; and necrotizing myopathy, NM);\n      2. Testing positive for myositis-specific antibodies;\n      3. For patients with muscle involvement, having a Manual Muscle Testing-8 (MMT-8) score below 142 and at least two abnormal findings among the following five core measures (Physician's Global Assessment, PhGA; Patient's Global Assessment, PtGA, or extra-muscular disease activity score ≥ 2 points; Health Assessment Questionnaire, HAQ, total score ≥ 0.25; muscle enzyme levels 1.5 times the upper limit of normal range); or having an MMT-8 score ≥ 142 but presenting with active interstitial lung disease (as indicated by ground-glass opacities on high-resolution computed tomography, HRCT);\n      4. Definition of relapsing and refractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.;\n      5. Definition of progressive condition: Demonstrating worsening myositis or rapidly progressive interstitial pneumonia.\n\n      Note: Meeting either criterion 4 or 5 is sufficient.\n\n      Relapsing and refractory Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis:\n      1. Meeting the 2022 American College of Rheumatology\u002FEuropean League Against Rheumatism (ACR\u002FEULAR) diagnostic criteria for ANCA-associated vasculitis, including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n      2. Testing positive for ANCA-related antibodies (either MPO-ANCA or PR3-ANCA positive).\n      3. A Birmingham Vasculitis Activity Score (BVAS) of ≥15 points (out of a total of 63 points), indicating active vasculitis.\n      4. Definition of relapsing\u002Frefractory condition: Persistence of disease activity or recurrence of disease activity after remission, despite undergoing conventional treatment for more than six months. Definition of conventional treatment: Administration of glucocorticoids and cyclophosphamide, in combination with any one or more of the following immunomodulatory agents: antimalarial drugs, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biological agents including rituximab, belimumab, telitacicept, etc.\n\n         Relapsing and refractory Antiphospholipid Syndrome:\n\n      1\\. Meeting the 2006 Sydney-revised diagnostic criteria for primary antiphospholipid syndrome; 2. Testing positive for antiphospholipid antibodies at moderate to high titers (IgG\u002FIgM antibodies against lupus anticoagulant, LA; beta-2 glycoprotein I, B2GP1; or anticardiolipin, acL, detected positive on more than two occasions within a 12-week period); 3. Definition of relapsing\u002Frefractory condition: Recurrence of thrombosis despite standard treatment with warfarin anticoagulation or alternative vitamin K antagonist (i.e., maintaining the required international normalized ratio, INR, for therapeutic management) or standard therapeutic doses of low molecular weight heparin (LMWH), in addition to previous treatment with corticosteroids and cyclophosphamide; 4. For catastrophic antiphospholipid syndrome, the following four criteria must be met: (1) involvement of three or more organs, systems, and\u002For tissues; (2) onset of symptoms within one week; (3) histological confirmation of small vessel occlusion in at least one organ or tissue; (4) presence of aPL (antiphospholipid antibodies).\n\n      Note: Meeting either criterion 3 or 4 is sufficient.\n\n      Exclusion Criteria:\n      * Subjects who meet any of the following exclusion criteria will not be admitted to the study:\n\n        1. Individuals with a severe history of drug allergies or those with an allergic constitution;\n        2. Individuals with existing or suspected uncontrolled or treatable fungal, bacterial, viral, or other infections;\n        3. Subjects with central nervous system diseases (excluding those with a history of epilepsy, psychiatric disorders, organic brain disease syndromes, cerebrovascular accidents, encephalitis, or central nervous system vasculitis resulting from the underlying disease);\n        4. Subjects whose cardiac function cannot tolerate the study interventions;\n        5. Subjects with congenital immunoglobulin deficiencies;\n        6. Subjects with a history of malignant tumors within the past five years;\n        7. Subjects with end-stage renal failure;\n        8. Subjects who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titers exceeding the upper limit of detection; subjects who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; subjects who are positive for human immunodeficiency virus (HIV) antibody; and subjects who are positive for syphilis testing;\n        9. History of symptomatic deep vein thrombosis or pulmonary embolism within the 6 months prior to screening;\n        10. Subjects with psychiatric disorders or severe cognitive dysfunction;\n        11. Subjects who have participated in other clinical trials within the past three months prior to enrollment;\n        12. Subjects who have received immunosuppressive agents with therapeutic effects on the disease within five half-lives prior to enrollment or biological agents within four weeks prior to enrollment;\n        13. Pregnant women or women planning to become pregnant;\n        14. Subjects whom the investigator believes have other reasons that preclude their inclusion in this study.","65 Years",{"count":189,"type":22},18,[135],"This study evaluates the safety and efficacy of YTS109 cells in adults with relapsed\u002Frefractory autoimmune diseases, such as Systemic Lupus Erythematosus (SLE), including LN and SLE-ITP, Sjogren's Syndrome, etc. Aproximately 18 patients aged 18-65 will receive a single infusion of YTS109 cells. The dose groups are set to commence at 3×10⁶ STAR -T cells\u002Fkg, employing a 3+3 escalation principle for dose titration. The primary objective of this study is to evaluate the safety of YTS109 cells therapy in treating recurrent\u002Frefractory autoimmune diseases, while the secondary objectives are to assess the efficacy of YTS109 cells as well as their pharmacokinetic and pharmacodynamic characteristics. The primary endpoint is observations of types, severity, and frequency of adverse events (AEs) and efficacy assessment. This single-arm, open-label trial will enroll patients across Bengbu Third People's Hospital.",[193,194,27,195,196,197],"Systemic Lupus Erythematosus","Lupus Nephritis (LN)","Inflammatory Myopathy","Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis","Antiphospholipid Syndrome","2026-03-02",{"date":171,"type":38},{"date":201,"type":38},"2025-11-24",{"date":203,"type":22},"2027-11-24",{"name":205,"class":151},"China Immunotech (Beijing) Biotechnology Co., Ltd.",{"id":207,"slug":208,"hasResults":12,"nctId":209,"briefTitle":210,"officialTitle":211,"acronym":212,"eligibilityCriteria":213,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":214,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":216,"conditions":217,"keywords":4,"overallStatus":219,"whyStopped":4,"lastUpdateSubmitDate":220,"lastUpdatePostDateStruct":221,"startDateStruct":222,"completionDateStruct":224,"leadSponsor":226,"locationsCount":46},"100443561","penn-sicca-follow-up-study-100443561","NCT05056012","Penn SICCA Follow-up Study","Penn Sjögren's International Clinical Collaborative Alliance (SICCA) Follow-up Study","PSFS","Inclusion Criteria:\n\n1. Previously participated in the SICCA study at Penn\n2. Be 18 years or older\n\n4\\. Have signed an IRB consent form agreeing to the terms of the study\n\nExclusion Criteria:\n\n1. Did not previously participate in SICCA study at Penn\n2. Under the age of 18 years",{"count":215,"type":22},220,"This study will involve the collection of follow-up data for patients who previously participated in the Sjogren's International Clinical Collaborative Alliance (SICCA) study at the University of Pennsylvania. Clinical data and specimens will be collected from subjects with objective evidence of dry eye who were or were not diagnosed with Sjogren's syndrome at the time of their initial participation in the SICCA study. Specimens will be collected from participants which will include tears, saliva, whole blood, serum, DNA and possible labial minor salivary gland biopsies when indicated. All individuals will participate in a standard evaluation protocol including an oral, ocular and physical examination, objective tests for dry eyes and dry mouth and, whenever necessary, a labial minor salivary gland biopsy. The biopsy requirement is waived for those who have already had positive lip biopsies in the past.",[218,27],"Dry Eye","NOT_YET_RECRUITING","2026-02-27",{"date":198,"type":38},{"date":223,"type":22},"2027-01",{"date":225,"type":22},"2029-01",{"name":227,"class":101},"University of Pennsylvania",{"id":229,"slug":230,"hasResults":12,"nctId":231,"briefTitle":232,"officialTitle":232,"acronym":4,"eligibilityCriteria":233,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":234,"enrollmentInfo":235,"targetDuration":237,"studyType":23,"phases":4,"briefSummary":238,"conditions":239,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":256,"lastUpdatePostDateStruct":257,"startDateStruct":259,"completionDateStruct":261,"leadSponsor":263,"locationsCount":46},"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":236,"type":22},5000,"10 Years","To facilitate clinical, basic science, and translational research projects involving the study of rheumatic diseases.",[240,241,242,243,244,197,193,245,246,247,248,249,250,251,252,253,167,254,27,255],"Rheumatic Diseases","Adult Onset Still Disease","Ankylosing Spondylitis","Psoriatic Arthritis","Reactive Arthritis","Behcet Disease","Dermatomyositis","Polymyositis","Giant Cell Arteritis","Lyme Disease","Mixed Connective Tissue Disease","Polymyalgia Rheumatica","Rheumatoid Arthritis","Sarcoidosis","Scleroderma","Undifferentiated Connective Tissue Diseases","2026-02-11",{"date":258,"type":38},"2026-02-13",{"date":260,"type":38},"2020-08-04",{"date":262,"type":22},"2030-06-01",{"name":264,"class":101},"Yale University",{"id":266,"slug":267,"hasResults":12,"nctId":268,"briefTitle":269,"officialTitle":270,"acronym":4,"eligibilityCriteria":271,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":19,"enrollmentInfo":272,"targetDuration":4,"studyType":58,"phases":274,"briefSummary":275,"conditions":276,"keywords":277,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":282,"startDateStruct":284,"completionDateStruct":286,"leadSponsor":287,"locationsCount":46},"100606821","creating-health-course-study-for-people-with-rheumatological-conditions-100606821","NCT07180537","Creating Health Course Study for People With Rheumatological Conditions","Transforming Health Habits: Evaluating an Online Wellness Program for Individuals With Rheumatological Conditions","Inclusion criteria:\n\n1. A diagnosis of one of the following: Rheumatoid Arthritis (RA), Sjogren's Syndrome, Systemic lupus erythematosus (SLE), Mixed connective tissue disease (MCTD), or Psoriatic Arthritis (PsA), as documented by their treating specialist or primary care provider, as reported by the participant.\n2. Must be age 18 and older, at time of consent.\n3. Must be fluent in both speaking and reading English.\n\n   \\*Study participant must be able to read and comprehend informed consent document and speak with study staff about study document content. Study staff will use discretion in determining whether the study participant can clearly communicate with staff and comprehend the study material during the consent call or prior to the call.\n4. Must have access to high-speed internet with devices capable of audio\u002Fvideo streaming.\n5. Must be willing to participate in an online health course designed to improve dietary intake and self-care routines to help improve cellular function and health, and complete online surveys over the course of a 6-month period.\n6. Individuals must pass the Short Portable Mental Status Questionnaire with scores for normal mental functioning (up to 2 errors). Cognitive impairment as measured by the SPMS Questionnaire could interfere with the completion of the online course.\n\nSCORING\\* 0-2 errors: normal mental functioning 3-4 errors: mild cognitive impairment 5-7 errors: moderate cognitive impairment 8-10 errors: severe cognitive impairment\n\n\\*Allow one more error for a subject with only a grade school education. Allow one less error for a subject with education beyond high school.\n\nSource: Pfeiffer, E. (1975). A short portable mental status questionnaire for the assessment of organic brain deficit in elderly patients. Journal of American Geriatrics Society. 23, 433-41.\n\nExclusion criteria:\n\n1. Inability to provide informed consent, including participation in a consent call conducted via Zoom with the study team during business hours (8:00 a.m. to 5:00 p.m. Central Time (Chicago)).\n2. Participation in another research study investigating an intervention (treatments, medications, diet, or exercise). Participation in observation-only studies are not excluded.\n3. Currently following a modified Paleolithic, low-fat nutrient-dense vegetarian, or Mediterranean diet with 75% OR greater reported compliance.\n4. Any diagnosis or condition that is contraindicated from starting a gentle exercise program (ex. poorly controlled diseases of the heart, kidney, or liver in the prior 12 months, or severe psychiatric disease, e.g., schizophrenia, making adherence to study procedures difficult.",{"count":273,"type":22},200,[91],"The goal of this project is to critically evaluate the effectiveness of an online health program designed to improve diet and self-care in patients with rheumatological conditions, including rheumatoid arthritis (RA), Sjogren's syndrome (SS), systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), psoriatic arthritis (PsA), Additionally, investigators will assess the program's effectiveness, as well as the challenges and facilitators involved in using an online wellness program to reduce fatigue and enhance the quality of life in patients suffering from these conditions.",[252,27,193,250,243],[278,279,280],"diet","self-care","internet course","2026-01-06",{"date":283,"type":38},"2026-01-08",{"date":285,"type":38},"2025-12-01",{"date":177,"type":22},{"name":288,"class":101},"Terry L. Wahls",{"id":290,"slug":291,"hasResults":12,"nctId":292,"briefTitle":293,"officialTitle":293,"acronym":294,"eligibilityCriteria":295,"healthyVolunteers":16,"sex":296,"minAge":4,"maxAge":4,"enrollmentInfo":297,"targetDuration":19,"studyType":23,"phases":4,"briefSummary":298,"conditions":299,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":281,"lastUpdatePostDateStruct":302,"startDateStruct":303,"completionDateStruct":305,"leadSponsor":307,"locationsCount":46},"100307028","maternal-autoimmune-disease-research-alliance-madra-registry-100307028","NCT03276923","Maternal Autoimmune Disease Research Alliance (MADRA) Registry","MADRA","Inclusion Criteria:\n\n* Desire for pregnancy within 6 months or currently pregnant\n* Women with systemic autoimmune disease, including:\n* Lupus (systemic lupus erythematosus or cutaneous lupus)\n* Antiphospholipid Syndrome or positive antiphospholipid antibodies\n* Rheumatoid Arthritis\n* Scleroderma (systemic sclerosis)\n* Sjogren's Syndrome\n* Inflammatory Arthritis (including Psoriatic Arthritis and Ankylosing Spondylitis)\n* Undifferentiated Connective Tissue Disease (UCTD)\n* Vasculitis\n* Myositis (Polymyositis or Dermatomyositis)\n* Positive Ro\u002FSSA or La\u002FSSB antibodies\n\nExclusion Criteria:\n\n* Unable to speak English\n* Unable to provide informed consent\n* Unable to travel to Duke University for follow-up visits","FEMALE",{"count":89,"type":22},"This multi-site registry, centered at Duke University, will enroll pregnant women with autoimmune and rheumatologic diseases.\n\nThe main goal of MADRA is to identify ways to improve the health of women with rheumatic diseases and their babies during pregnancy.\n\nPrior studies demonstrate the importance of increase inflammation prior to and during pregnancy on these outcomes. The future research will seek to better define these risk factors and to identify ways to may improve them.",[170,300,193,301,252,27,254],"Pregnancy Related","Cutaneous Lupus",{"date":283,"type":38},{"date":304,"type":38},"2018-01-01",{"date":306,"type":22},"2027-01-01",{"name":308,"class":101},"Duke University",{"id":310,"slug":311,"hasResults":12,"nctId":312,"briefTitle":313,"officialTitle":314,"acronym":4,"eligibilityCriteria":315,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":316,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":318,"conditions":319,"keywords":334,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":339,"startDateStruct":341,"completionDateStruct":342,"leadSponsor":344,"locationsCount":46},"100616152","generative-ai-impact-on-rheumatoid-arthritis-complications-diagnosis-100616152","NCT07301892","Generative AI Impact on Rheumatoid Arthritis Complications Diagnosis","Impact of Generative Artificial Intelligence on Diagnosing Rheumatoid Arthritis Complications","Inclusion Criteria:\n\n* Patients with an initial diagnosis of rheumatoid arthritis (RA).\n* All real-world RA inpatients admitted to our department.\n* Admission occurring within the real-world data study period.\n\nExclusion Criteria:\n\n* Patients subsequently confirmed not to have RA during the study.",{"count":317,"type":22},100,"Generative AI (GenAI) based on large language models (LLMs) is expected to improve the diagnosis and treatment of autoimmune diseases. We are studying how GenAI may affect the diagnosis of various complications of rheumatoid arthritis (RA). In a retrospective study using RA patients' EHR records, we will quantify physician adoption of GenAI predictions for RA complications and co-existing diseases. In a prospective observational study, we will assess the feasibility of using GenAI predictions as additional clinical information to help physicians make more complete diagnoses of RA complications and co-existing diseases, including complex, uncommon, or rare conditions.",[320,321,322,323,324,325,326,27,327,328,329,330,331,332,333],"Rheumatoid Arthritis (RA","Osteoporosis","Osteoarthritis","Interstitial Lung Disease","Thyroid Diseases","Cardiovascular Diseases","Pulmonary Complications","Liver Disorders","Renal Lesions","Vasculitis","Amyloidosis","Peripheral Neuropathy","Thrombosis","RA Complications",[252,335,336,337],"generative AI","large language model","Rheumatoid arthritis complications","2025-12-22",{"date":340,"type":38},"2025-12-24",{"date":146,"type":38},{"date":343,"type":22},"2026-06",{"name":345,"class":101},"Guang'anmen Hospital of China Academy of Chinese Medical Sciences",{"id":347,"slug":348,"hasResults":12,"nctId":349,"briefTitle":350,"officialTitle":351,"acronym":352,"eligibilityCriteria":353,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":354,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":355,"conditions":356,"keywords":363,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":338,"lastUpdatePostDateStruct":368,"startDateStruct":370,"completionDateStruct":372,"leadSponsor":374,"locationsCount":46},"100580823","effects-of-phytocannabinoids-on-immune-response-and-autophagy-during-chronic-immune-mediated-inflammatory-diseases-100580823","NCT06842316","Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases","In Vitro Effects of Phytocannabinoids on Immune Response and Autophagy During Chronic Immune-mediated Inflammatory Diseases","pCB-IMIDs","Inclusion Criteria:\n\n1. Male or female ≥ 18 years old\n2. Diagnosis confirmed by a rheumatologist of RA or spondyloarthropathy (with or without IBD) or psoriatic arthritis (with or without active psoriasis) or systemic lupus erythematosus or Sjögren's disease\n3. Patient who has expressed consent to participate in the study\n4. Patients affiliated to social security\n5. Treatments authorized as part of routine care: non-steroidal anti-inflammatory drugs (NSAIDs), level 1 to 3 analgesics, local corticosteroids, oral corticosteroid therapy (daily dose ≤15 mg\u002Fd), 5-aminosalicylic acid, salazopyrine, methotrexate, leflunomide, hydroxychloroquine, biotherapies and targeted therapies.\n\nExclusion Criteria:\n\n1. Patient who received intravenous corticosteroid therapy less than 4 weeks ago\n2. Patient receiving oral corticosteroid therapy with a daily dose \\>15 mg\u002Fday\n3. Consumption of CBD and\u002For recreational cannabis and\u002For positive saliva test for cannabis consumption and\u002For CBD\n4. Pregnant and lactating women\n5. Persons under guardianship or curatorship",{"count":317,"type":22},"Cannabis, in addition to its psychotropic properties, could have anti-inflammatory and immunomodulatory effects. Phytocannabinoids (pCBs) are a group of molecules naturally secreted by the cannabis plant. The major pCBs are cannabidiol (CBD) and Δ9-tetrahydrocannabinol Δ9 (THC). Only THC has psychotropic effects, which CBD does not have. Alongside these two main components, there is a wide variety of other molecules, such as other pCBs and terpenes which could increase the effects on immune system through synergistic interactions between these different compounds (\"entourage effect\").In vivo, pCBs essentially interfere with the endocannabinoid system, acting on many ubiquitous receptors, present on a significant number of different cell types. Numerous published studies show that pCBs have immunomodulatory and anti-inflammatory properties by acting on several of these receptors, whether through modulation of the immune response of different cell types, effects on cytokine networks, reduction of innate and adaptive responses and\u002For impact on cell survival or death (autophagy, proliferation\u002F apoptosis). The Immune-Mediated Inflammatory Diseases (IMIDs) affect 5 to 7% of the general population in Western countries, involve different organs (joints, skin, digestive tract) but share the same inflammatory mechanisms resulting from a dysregulation of the immune response. Our research focuses on the identification of the most effective phytochemical profile of pCBs, allowing an optimal effect on chronic inflammatory pathologies of interest among immune-mediated chronic inflammatory diseases (IMIDs). The pCB-IMIDs project is therefore part of an innovative translational project, around new therapeutic applications of medical cannabis (CannAppIMIDs). In our study, we will include 100 patients with one of IMIDs among Rheumatoid Arthritis, spondylarthritis, psoriatic arthritis, Sjogren disease and systemic lupus, at different stage and with different treatments. After patient's consent we will collect for research purposes an additional 40 ml of blood during a routine care blood test. Mononuclear and polynucleated blood cells will be exposed in vitro to different full-spectrum pCB extracts (full spectrum extract) including a CBD dominant and low THC extract (\\\u003C0.2%), 1 dominant THC extract, 1 balanced THC\u002FCBD extract and 1 dominant CBG extract. In this cross-sectional study, our objective will be to assess the biological effects of different pCB compositions on inflammatory profiles (concentrations of pro and anti-inflammatory cytokines and chemokines) and modulations of expression profiles (autophagy, apoptosis, and cannabinoid receptor expression profile).",[357,358,359,360,361,27,362],"Inflammatory Disorder of Immune System","Spondylitis, Ankylosing","Arthritis, Rheumatoid","Arthritis, Psoriatic","Inflammatory Bowel Diseases","Lupus Erythematosus, Systemic",[364,365,366,367],"IMIDs","phytocanabinoid","inflammatory effect","blood cells",{"date":369,"type":38},"2025-12-30",{"date":371,"type":38},"2025-04-10",{"date":373,"type":22},"2027-04-09",{"name":375,"class":101},"Centre Hospitalier Régional d'Orléans",{"id":377,"slug":378,"hasResults":12,"nctId":379,"briefTitle":380,"officialTitle":381,"acronym":4,"eligibilityCriteria":382,"healthyVolunteers":16,"sex":17,"minAge":54,"maxAge":383,"enrollmentInfo":384,"targetDuration":4,"studyType":58,"phases":385,"briefSummary":386,"conditions":387,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":388,"lastUpdatePostDateStruct":389,"startDateStruct":390,"completionDateStruct":392,"leadSponsor":393,"locationsCount":46},"100597748","phase-1-analyse-of-inflammatory-activity-of-sjgrens-syndrome-on-68ga-fapi-pet-ct-100597748","NCT07062523","Analyse of Inflammatory Activity of Sjögren's Syndrome on 68Ga-FAPI PET-CT","Application of [68Ga]Ga-FAPI-04 PET\u002FCT in the Assessment of Inflammatory Activity in Sjögren's Syndrome","Inclusion Criteria:\n\n* Age 18-80 years;\n* Fulfillment of the 2016 ACR-EULAR Classification Criteria for pSS at enrollment. OR diagnosis of a solid tumor scheduled for FAPI PET imaging\n\nExclusion Criteria:\n\n* Combined with tumors or other connective tissue diseases (for SS group);\n* Patients who are currently using hormones\u002Fbiological agents (for both groups)；\n* Pregnancy or lactation","80 Years",{"count":57,"type":22},[135,60],"Sjögren's syndrome (SS) is a chronic autoimmune disease primarily affecting the salivary and lacrimal glands, leading to symptoms of dryness. Assessing the inflammatory activity is crucial for guiding treatment. Fibroblast activation protein (FAPI) PET is an emerging imaging technique increasingly used for evaluating various inflammations and tumors. Thus this prospective study is going to investigate the uptake characteristics of FAPI PET in Sjögren's syndrome and evaluate its potential in assessing inflammatory activity to guide clinical treatment. A control group of tumor patients undergoing FAPI PET imaging will be included to compare FAPI uptake patterns between autoimmune inflammation and neoplasia.",[27],"2025-11-23",{"date":285,"type":38},{"date":391,"type":38},"2024-07-01",{"date":285,"type":22},{"name":394,"class":101},"Peking Union Medical College Hospital",{"id":396,"slug":397,"hasResults":12,"nctId":398,"briefTitle":399,"officialTitle":400,"acronym":401,"eligibilityCriteria":402,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":383,"enrollmentInfo":403,"targetDuration":4,"studyType":58,"phases":404,"briefSummary":405,"conditions":406,"keywords":408,"overallStatus":219,"whyStopped":4,"lastUpdateSubmitDate":409,"lastUpdatePostDateStruct":410,"startDateStruct":412,"completionDateStruct":414,"leadSponsor":416,"locationsCount":4},"100538928","phase-1-r-2487-in-patients-with-sjogrens-syndrome-ss-100538928","NCT06297213","R-2487 in Patients With Sjogren's Syndrome (SS)","A Single and Repeat Dosing Study of the Safety, Drug Exposure and Clinical Activity of R-2487 in Patients With Sjogren's Syndrome (SS)","R-2487-SS-01","Inclusion Criteria:\n\n* Diagnosis of SS according to American-European Consensus Group Criteria\n* Able to provide informed consent\n* Subjects receiving prednisone (10 mg or less\u002Fday) must be on a stable dose for more than 2 weeks\n* All male and female subjects who are biologically capable of having children must agree to use medically acceptable method of birth control for the duration of the study. All female subjects who are biologically capable of having children must have a negative pregnancy test result before administration of investigational product.\n* The use of probiotics prior to study enrollment is accepted; however, during the course of the study, the use of probiotics is forbidden.\n\nExclusion Criteria:\n\n* No known active overlapping or associated other autoimmune disease\n* Prior allogenic or autologous bone marrow or organ transplantation\n* Subjects with prior irradiation to the head and neck, including radioactive iodine treatment for hyperthyroidism\n* Subjects who have a present malignancy or previous malignancy within the last 5 years prior to screening (except documented history of cured non-metastatic squamous or basal cell skin carcinoma or cervical carcinoma in situ). Subjects who had a screening procedure that is suspicious for malignancy, and in whom the possibility of malignancy cannot be reasonably excluded following additional clinical, laboratory or other diagnostic evaluations.\n* Subjects with positive results for human immunodeficiency virus (HIV), hepatitis A virus (HAV), hepatitis B virus (HBV), or hepatitis C virus (HCV)\n* Subjects with active viral, bacterial, or fungal infection, or history of severe opportunistic infection within the preceding 3 months, or COVID-19 infection in the past 3 months\n* Subjects with evidence of active or latent tuberculosis\n* Active infection of the salivary or lacrimal glands\n* Prior immunotherapy, biologics, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to the first dose of R-2487 DP\n* Pregnant or breastfeeding women\n* Current clinical findings of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, cardiac, endocrine, neurological, or cerebral disease with laboratory values as following:\n\nHemoglobin level \\\u003C 9.0 g\u002FdL\n\nAbsolute white blood cell (WBC) count of \\\u003C3.0×109\u002FL (\\\u003C3000\u002Fmm3), or absolute neutrophil count of \\\u003C1.2×109\u002FL (\\\u003C1200\u002Fmm3), or absolute lymphocyte count of \\\u003C0.8×109\u002FL (\\\u003C800\u002Fmm3).\n\nThrombocytopenia, defined by platelet count \\\u003C100×109\u002FL (\\\u003C100,000\u002Fmm3)\n\nChronic kidney disease defined as Estimated glomerular filtration rate (eGFR) \\\u003C60 mL\u002Fmin\u002F1.73m2, based on the age appropriate calculation.\n\nProteinuria ≥3+.\n\nTotal bilirubin (T-bili), aspartate aminotransferase (AST), alanine aminotransferase (ALT) more than 1.5 times upper limit of normal (ULN).\n\nPreviously diagnosed hepatic cirrhosis (Child Pugh A or higher) or previously diagnosed significant liver fibrosis (\\> F3)\n\n* Any form of vaccination in the last 30 days, to include but not limited to influenza, COVID, shingles, tetanus, hepatitis, pneumonia, HPV, DPT, MMR, and polio.\n* Subjects should not receive any of the following medications:\n\nRituximab or belimumab within 6 months prior to Day 1 Abatacept within 3 months prior to Day 1 Infliximab, Adalimumab, Certolizumab, Tocilizumab, Cyclosporine, or Mycophenolate mofetil within 2 months prior to Day 1 Etanercept, Anakinra, Immunoglobulin, or blood products within 28 days prior to Day 1\n\n* Prior immunotherapy, including systemic corticosteroids, such prednisone, biologics, Janus kinase (JAK) inhibitors (such as tofacitinib, or upadacitinib), ozanimod, or investigational therapy must have completed at least 5 half-lives or 30 days, whichever is longer, prior to Day 0, unless otherwise specified. In the case of cell-depleting therapies, such as B or T cell depletion, cell counts must have recovered to acceptable or baseline levels (use of licensed agents for indications not listed in the package insert is permitted).",{"count":133,"type":22},[135],"The goal of this study is to determine the safety and tolerability of orally taken probiotic (R-2487) in patients with Sjogren's Syndrome.\n\nPatients will take an oral dosage of probiotic (R-2487) and physicians will assess and measure their Sjogren's Syndrome. Blood and fecal evaluations of inflammation and assessment of probiotic (R-2487) on fecal level will also be measured.",[27,138,407],"Sjögren Syndrome, Unspecified",[27],"2025-08-27",{"date":411,"type":38},"2025-09-04",{"date":413,"type":22},"2026-06-01",{"date":415,"type":22},"2028-08-30",{"name":417,"class":151},"Rise Therapeutics LLC",{"id":419,"slug":420,"hasResults":12,"nctId":421,"briefTitle":422,"officialTitle":423,"acronym":424,"eligibilityCriteria":425,"healthyVolunteers":12,"sex":17,"minAge":4,"maxAge":4,"enrollmentInfo":426,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":428,"conditions":429,"keywords":435,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":445,"lastUpdatePostDateStruct":446,"startDateStruct":448,"completionDateStruct":450,"leadSponsor":452,"locationsCount":454},"100508736","armenian-nationwide-registry-of-systemic-autoimmune-and-autoinflammatory-diseases-100508736","NCT05904301","Armenian NAtionwide REGistry of Systemic Autoimmune and Autoinflammatory Diseases","Armenian Nationwide Registry of Systemic Autoimmune and Autoinflammatory Diseases","NAREG","Inclusion Criteria:\n\n1. Patients with a confirmed diagnosis of at least one of following autoimmune systemic diseases:\n\n   Behcet disease, ANCA -positive vasculitis, Takayasu arteritis, Giant cell arteritis, Systemic sclerosis, Sjogren syndrome, Rheumatoid arthritis, Spondylarthritis (psoriatic, ankylosing, crohn's related), Angioedema hereditary and acquired, Pediatric dermatology, Autoinflammatory diseases (hereditary and acquired), Unexplained infertility, Immune thrombocytopenic purpura\u002F Autoimmune hemolytic anemia (ITP, AHA), Primary anti-phospholipid syndrome (APS), Celiac disease.\n2. Age: major and minor\n3. Patients who have been informed and provided with written informed consent to participate Or consent from legal representative\n\nExclusion Criteria:\n\n1. Patients refusing to participate in the registry\n2. Non-consent from legal representative\n3. Breastfeeding or pregnant patients",{"count":427,"type":22},800,"Longitudinal prospective multicenter Armenian registry of systemic autoimmune, autoinflammatory diseases with constitution of bio-banking.",[245,430,431,248,27,252,432,433,434],"Antineutrophil Cytoplasmic Antibody (ANCA) Positive Vasculitis","Takayasu Arteritis","Hereditary and Acquired Angioedema","Primary Antiphospholipid Syndrome","Celiac Disease",[436,437,438,439,440,441,442,443,444],"arthritis","autoimmune","systemic","autoinflammatory","Behcet","Takayasu","Giant Cell","Angioedema","APS","2025-04-04",{"date":447,"type":38},"2025-04-08",{"date":449,"type":38},"2023-06-21",{"date":451,"type":22},"2028-06-30",{"name":453,"class":101},"Santé Arménie French-Armenian Research Center",6,{"id":456,"slug":457,"hasResults":12,"nctId":458,"briefTitle":459,"officialTitle":460,"acronym":461,"eligibilityCriteria":462,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":463,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":465,"conditions":466,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":468,"lastUpdatePostDateStruct":469,"startDateStruct":471,"completionDateStruct":473,"leadSponsor":475,"locationsCount":46},"100510534","assessment-of-physician-consideration-of-epros-from-patients-with-gout-rheumatoid-arthritis-sjogrens-syndrome-or-systemic-lupus-on-the-frequency-of-therapeutic-adjustments-100510534","NCT05927688","Assessment of Physician Consideration of EPRO's, from Patients with Gout, Rheumatoid Arthritis, Sjogren's Syndrome or Systemic Lupus, on the Frequency of Therapeutic Adjustments","Assessment of Physician Consideration of Electronic Patient Reported Outcomes, from Patients with Gout, Rheumatoid Arthritis, Sjogren's Syndrome or Systemic Lupus Erythematosus, on the Frequency of Therapeutic Adjustments","CAPTAIN","Inclusion Criteria:\n\n* Men or women of at least 18 years of age\n* Diagnosed with (at least) one of the following autoimmune diseases:\n\n  * Rheumatoid arthritis (RA) according to the 2010 EULAR\u002FACR classification criteria,\n  * Gout according to the 2015 EULAR\u002FACR classification criteria,\n  * Systemic lupus erythematosus according to the 2019 EULAR\u002FACR classification criteria\n  * Sjogren's Syndrome according to the 2016 EULAR\u002FACR classification criteria\n* According to local regulations, patient has expressed his\u002Fher non-opposition (for France) or has provided written informed consent (for Switzerland and Germany) to participate in the study\n* Patient has access to the internet, a functioning email address and a mobile phone number\n* Patient physically and mentally able to use a computer tool connected to the Internet\n* Only in Switzerland \\& Germany : patient is covered by a health insurance plan\n\nExclusion Criteria:\n\n* Any neurodegenerative disease that alters cognitive faculties\n* Refractory cancer\n* Patients who do not have access to the Internet and\u002For do not master its use in the context of this protocol\n* Unwillingness or inability to adhere to study protocol (language barriers, cognitive disorders…) Subject who is compulsorily detained for psychiatric treatment\n* Patient who cannot be followed for 2 years by the investigating physician\n* Patient over the age of legal majority who is protected, or deprived of liberty by judicial or administrative decision (vulnerable subject)\n* Patient with an estimated life expectancy shorter than 1 year",{"count":464,"type":22},352,"Inflammatory rheumatic diseases affect 1% of the population. Treatment of such diseases should be based on disease activity, safety issues and other patient characteristics such as comorbidities (EULAR, 2022), leading to a higher risk of cardiovascular diseases. To this end, the general treat-to-target approach, as recommended in the EULAR guidance, may require several successive treatment lines based on updates to the patients' profile and close monitoring as the keystone of its implementation.\n\nRegular feedback from patients could be used to fuel such strategies. This feedback can be collected using an ePRO (electronic Patient Reported Outcome). The purpose of this study is therefore to assess patient management using the information provided by patients through e-PROs, which will transfer the data provided by the patient to the physician and will notify the investigators via email when a patient has completed a form (no data interpretation or alerts).\n\nThe hypothesis is that the more physicians are provided with insights into their patients' health, the more they will function in a treat-to-target approach and the more often they will tend to adjust their patients' treatments.",[467,252,27,193],"Gout","2025-03-10",{"date":470,"type":38},"2025-03-12",{"date":472,"type":38},"2023-07-18",{"date":474,"type":22},"2027-07",{"name":476,"class":101},"University Hospital, Strasbourg, France",{"id":478,"slug":479,"hasResults":12,"nctId":480,"briefTitle":481,"officialTitle":482,"acronym":4,"eligibilityCriteria":483,"healthyVolunteers":16,"sex":17,"minAge":484,"maxAge":55,"enrollmentInfo":485,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":486,"conditions":487,"keywords":489,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":498,"lastUpdatePostDateStruct":499,"startDateStruct":501,"completionDateStruct":503,"leadSponsor":505,"locationsCount":46},"100575372","exosomes-proteomic-for-sjogrens-syndrome-and-dry-eye-syndrome-100575372","NCT06771427","Exosomes Proteomic for Sjogren's Syndrome and Dry Eye Syndrome","Systemic Proteomic Analysis of Plasma Exosomes to Explore the Immunomodulation Reflected to Sjogren's Syndrome and Dry Eye Syndrome","Dry eye syndrome\n\nInclusion Criteria: aged between 20 and 75 years Schirmer's test less than 10 mm\u002F5 min Exclusion Criteria: Pregnancy With eye inflammation or infectious eye disease Accepted operation of eye Sjögren's syndrome\n\nInclusion Criteria: primary or secondary SS aged between 20 and 75 years fulfilled the 2002 American-European Consensus Criteria for SS (AECG) had no abnormal findings of immune, liver, kidney, or blood function evaluations.\n\nExclusion Criteria: a history of alcohol abuse, diabetes mellitus, or major life-threatening condition pregnancy or breastfeeding steroid pulse therapy within three months prior to the commencement of our study.\n\nnon AIDDES Healthy Controls\n\nInclusion Criteria: aged between 20 and 75 years without any Chronic disease Exclusion Criteria: any Sjögren's syndrome or Dry eye syndrome.","20 Years",{"count":215,"type":22},"By analyzing the differential proteins in exosomes, this study aims to understand the pathological mechanisms of SJS and DES, identify potential diagnostic and therapeutic methods, and advance the diagnosis and treatment of these diseases.",[488,27,70],"Dry Eye Syndrome (DES)",[490,491,70,492,493,494,495,496,497],"Dry eye syndrome","Sjögren's syndrome","Chinese herbal tea","Nourishing Yin and Moistening Dryness","Exosome","GB20","BL2","proteomics","2025-01-15",{"date":500,"type":38},"2025-01-17",{"date":502,"type":38},"2025-01-16",{"date":504,"type":22},"2026-12-31",{"name":506,"class":507},"Taipei Veterans General Hospital, Taiwan","OTHER_GOV",{"id":509,"slug":510,"hasResults":12,"nctId":511,"briefTitle":512,"officialTitle":513,"acronym":4,"eligibilityCriteria":514,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":187,"enrollmentInfo":515,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":517,"conditions":518,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":524,"lastUpdatePostDateStruct":525,"startDateStruct":527,"completionDateStruct":529,"leadSponsor":531,"locationsCount":46},"100542214","rheumatology-diet-study-100542214","NCT06339957","Rheumatology Diet Study","Title of Study: Eating Habits and Symptom Severity in Autoimmune Diseases: a Patient Survey","Inclusion Criteria:\n\n* Adults (over 18 years old) patients\n* established UCF Health patients\n* diagnosed with rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis, dermatomyositis\u002Fpolymyositis, Sjogren's Syndrome, systemic lupus erythematous, scleroderma, osteoarthritis, or fibromyalgia.\n\nExclusion Criteria:\n\n* UCF Students, Faculty or Staff\n* Children or Young Adults Under the age of 18\n* Adults over 65\n* Pregnant Women\n* Prisoners\n* Adults to Unable to Consent",{"count":516,"type":22},500,"This study aims to collect information on rheumatology patients' dietary habits, autoimmune disease activity, dietary changes, disease symptom improvements, and perceptions on their dietary habits and how it affects their autoimmune disease. The main objective is to see if rheumatology patients change their dietary habits after their diagnosis of an autoimmune disease and if it subjectively improved their disease symptoms. It will also look at rheumatology patients' expectations for their rheumatologist when it comes to dietary advice and what resources they used to choose their new dietary habits. The study also seeks to measure the interest that rheumatology patients have in pursuing dietary changes as a means of controlling the symptoms of their autoimmune disease. It is expected that patients who changed their eating habits to healthier diets such as a Mediterranean diet would report less severe autoimmune disease symptoms. There are limited dietary recommendations for the management of many rheumatological diseases, so this study seeks to assess rheumatology patients' willingness to try dietary modifications, what improvements they had, and why they decide to make these changes in light of limited information.",[519,520,170,252,243,242,521,27,522,254,523],"Diet Habit","Rheumatologic Disease","Dermatomyositis\u002Fpolymyositis","Systemic Lupus Erythematous","Fibromyalgia","2024-12-03",{"date":526,"type":38},"2024-12-06",{"date":528,"type":38},"2024-03-01",{"date":530,"type":22},"2025-07-01",{"name":532,"class":101},"University of Central Florida",{"id":534,"slug":535,"hasResults":12,"nctId":536,"briefTitle":537,"officialTitle":537,"acronym":538,"eligibilityCriteria":539,"healthyVolunteers":12,"sex":17,"minAge":540,"maxAge":541,"enrollmentInfo":542,"targetDuration":4,"studyType":58,"phases":543,"briefSummary":544,"conditions":545,"keywords":547,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":549,"lastUpdatePostDateStruct":550,"startDateStruct":552,"completionDateStruct":554,"leadSponsor":556,"locationsCount":46},"100548991","phase-1-sequential-car-t-cells-targeting-bcmacd19-in-patients-with-relapsed-refractory-autoimmune-diseases-100548991","NCT06428188","Sequential CAR-T Cells Targeting BCMA\u002FCD19 in Patients With Relapsed\u002F Refractory Autoimmune Diseases","BAH247","Inclusion Criteria:\n\n* Expected survival time ≥3 months;\n* Subjects with recurrent\u002Frefractory autoimmune diseases who have failed standard treatment or lack effective treatment, Including but not limited to systemic lupus erythematosus, idiopathic inflammatory myopathy, systemic sclerosis, IGG4-associated diseases, primary Sjogren's syndrome, rheumatoid arthritis, connective tissue disease-associated interstitial lung disease, immune thrombocytopenia, primary biliary cholangitis, etc.\n* Histological evidence of non-suppurative destructive cholangitis and small bile duct destruction.\n* Liver and kidney function, cardiopulmonary function meet the following requirements:\n* Creatinine ≤1.5×ULN; (2) Electrocardiogram showed no clinically significant abnormal bands;\n* Blood oxygen saturation \\>91% in non-oxygen state;\n* Total bilirubin ≤2×ULN; ALT and AST≤2.5 x ULN; ALT and AST abnormalities due to disease, such as liver infiltration or bile duct obstruction, were determined to be less than 5×ULN. If Gilbert syndrome is diagnosed, the total bilirubin index can be relaxed to ≤3.0×ULN and the direct bilirubin ≤1.5×ULN.\n* No serious mental disorders;\n* Can understand this test and have signed the informed consent.\n\nExclusion Criteria:\n\n* Malignant tumors other than R\u002FR AID disease in the 5 years prior to screening, except for adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and breast ductal carcinoma in situ after radical surgery;\n* Hepatitis B surface antigen (HBsAg) positive; Hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer detection is not within the normal reference value range; Hepatitis C virus (HCV) Antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive; Human immunodeficiency virus (HIV) Antibody positive; Syphilis positive;\n* Serious heart disease, including but not limited to unstable angina, myocardial infarction or bypass or stent surgery (within 6 months prior to screening), congestive heart failure (NYHA classification ≥III), and severe arrhythmia;\n* Systemic diseases that are deemed unstable by researchers: including but not limited to severe liver, kidney, or metabolic diseases that require drug treatment;\n* Active or uncontrollable infections (except mild genitourinary and upper respiratory tract infections) that require systemic treatment within 7 days prior to administration;\n* Pregnant or lactating women, and female subjects who plan pregnancy within 2 years after cell transfusion or male subjects whose partners plan pregnancy within 2 years after cell transfusion;\n* Patients who received CAR-T therapy or other gene-modified cell therapy before screening;\n* Participated in other clinical studies 1 month before screening;\n* Evidence of central nervous system invasion during subject screening;\n* Mental patients with depression or suicidal thoughts;\n* Situations considered unsuitable for inclusion by other researchers.","21 Years","90 Years",{"count":57,"type":22},[135,60],"This is an open, single-arm, clinical study to evaluate the efficacy and safety of chimeric antigen receptor T cell immunotherapy (CAR-T) targeting BCMA or CD19 or both sequentially in the treatment of Relapsed\u002F Refractory Autoimmune Disease such as Sjogren's Syndrome or Systemic Lupus Erythematosus and other Autoimmune Disease.",[170,193,546,27],"Systemic Lupus Erythematosus Acute",[27,193,170,548],"CAR-T","2024-11-04",{"date":551,"type":38},"2024-11-05",{"date":553,"type":38},"2024-05-29",{"date":555,"type":22},"2026-12-28",{"name":557,"class":101},"Essen Biotech",{"id":559,"slug":560,"hasResults":12,"nctId":561,"briefTitle":562,"officialTitle":563,"acronym":564,"eligibilityCriteria":565,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":541,"enrollmentInfo":566,"targetDuration":4,"studyType":58,"phases":568,"briefSummary":569,"conditions":570,"keywords":574,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":576,"lastUpdatePostDateStruct":577,"startDateStruct":579,"completionDateStruct":581,"leadSponsor":583,"locationsCount":46},"100542995","phase-1-fourth-gen-car-t-cells-targeting-bcmacd19-for-refractory-systemic-lupus-erythematosus-sle-100542995","NCT06350110","Fourth-gen CAR T Cells Targeting BCMA\u002FCD19 for Refractory Systemic Lupus Erythematosus (SLE)","T-cell Infusion Targeting BCMA and CD19 for Refractory\u002FRelapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement","BAH242","Inclusion Criteria:\n\n* 18-90 years old;\n* Total score ≥ 10 on the EULAR\u002FACR 2019 SLE classification criteria.\n* SELENA-SLEDAI≥8.\n* Patients with CD19+ B-cell.\n* Hemoglobin≥85 g\u002FL.\n* WBC≥2.5×10\\^9\u002FL.\n* NEUT≥1×10\\^9\u002FL.\n* BPC≥50×10\\^9\u002FL.\n* AST\u002FALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL\u002Fmin; blood bilirubin ≤2.0 mg\u002Fdl; echocardiography indicates that the ejection fraction is ≥50%.\n* Adequate venous access for apheresis, and no other contraindications for leukapheresis.\n* Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline.\n* Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.\n* Agree to attend follow-up visits as required.\n* Voluntary participation and informed consent signed by the patient or his\u002Fher legal\u002Fauthorized representative.\n\nExclusion Criteria:\n\n* Renal disease: severe lupus nephritis (serum creatinine \\> 2.5 mg\u002FdL or 221 μmol\u002FL) within 8 weeks --Prior to leukapheresis, or subjects who need hemodialysis.\n* CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident \\[CVA\\], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts.\n* Patients with serious lesions and a history of present illness of vital organs such as the heart, liver,kidney blood and endocrine system.\n* Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;\n* Received immunosuppressive therapy within 1 week prior to leukapheresis.\n* Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus.\n* Patients with syphilis infection.\n* The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening.\n* Received live vaccine treatment within 4 weeks prior to screening.\n* Severe allergies or hypersensitivity.\n* Contraindication to cyclophosphamide in combination with fludarabine.\n* Subjects who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the infusion.\n* Cannula or drainage tubes other than central venous catheters.\n* Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment;\n* Subjects with prior CD19 or BCMA-targeted therapy.\n* Participated in any clinical study within 3 months prior to enrollment.\n* Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS\\>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer.",{"count":567,"type":22},75,[135,60],"This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.",[193,571,170,196,572,573,167,169,27],"Lupus Nephritis","Granulomatous Polyangiitis","Microscopic Polyangiitis",[575],"CAR-T Cell Therapy","2024-10-11",{"date":578,"type":38},"2024-10-15",{"date":580,"type":38},"2024-07-10",{"date":582,"type":22},"2025-12-28",{"name":557,"class":101},{"id":585,"slug":586,"hasResults":12,"nctId":587,"briefTitle":588,"officialTitle":589,"acronym":4,"eligibilityCriteria":590,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":187,"enrollmentInfo":591,"targetDuration":4,"studyType":58,"phases":592,"briefSummary":593,"conditions":594,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":595,"lastUpdatePostDateStruct":596,"startDateStruct":598,"completionDateStruct":600,"leadSponsor":602,"locationsCount":46},"100545265","an-clinical-study-of-yts109-cell-injection-in-subjects-with-recurrentrefractory-autoimmune-disease-100545265","NCT06379646","An Clinical Study of YTS109 Cell Injection in Subjects With Recurrent\u002FRefractory Autoimmune Disease","An Exploratory Clinical Study of the Safety and Efficacy of YTS109 Cell Injection in Subjects With Recurrent\u002FRefractory Autoimmune Disease","Inclusion Criteria:\n\n1. Age ranges from 18 to 65 years old (including threshold), regardless of gender.\n2. Positive expression of CD19 on peripheral blood B cells determined by flow cytometry.\n3. The functions of important organs meet the following requirements:\n\n   1. Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×109\u002FL; Hemoglobin ≥60g\u002FL;\n   2. Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;\n   3. Renal function: creatinine clearance (CrCl) ≥30 ml\u002Fminute;\n   4. Coagulation function: International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN;\n   5. Heart function: good hemodynamic stability;\n4. Female subjects with fertility and male subjects whose partners are women of childbearing age are required to use medically approved contraception or abstinence during the study treatment period and at least 6 months after the end ofthe study treatment period; Female subjects of childbearing age tested negative for serum HCG within 7 days before enrollment in the study and were not in lactation.\n5. Voluntarily participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.\n\nSpecific inclusion criteria:\n\nRecurrent refractory systemic lupus erythematosus\n\n1. Complies with the classification standards of the 2019 European Union Against Rheumatology\u002FAmerican Society of Rheumatology (EULAR\u002FACR) SLE;\n2. Disease activity score SELENA SLEDAI≥6 with at least one Injima Lupus Assessment Group Index (BILAG-2004) category A (severe presentation) or two Category B (moderate presentation) organ scores, or both; Or disease activity score SELENA SLEDAI score ≥8;\n3. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.\n\nRecurrent refractory sjogren's syndrome\n\n1. Meet the 2002 AECG criteria for primary Sjogren's syndrome or the 2016 ACR\u002FEULAR classification criteria;\n2. Disease activity ESSDAI≥6;\n3. Positive anti-SSA \u002FRo antibody;\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.\n\nRelapsing refractory\u002Fprogressive diffuse systemic sclerosis\n\n1. Meet the 2013 ACR classification criteria for systemic sclerosis;\n2. Positive antibodies related to systemic sclerosis;\n3. Diffuse sclerosis of the skin or active interstitial pneumonia (HRCT suggests ground glass exudation);\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept\n5. Definition of progression: rapid skin progression (mRSS increase \\>25%); Or progression of lung disease (a 10% reduction in FVC, or a more than 5% reduction in FVC with a 15% reduction in DLCO).\n6. Note: Articles 4 and 5 satisfy one or the other.\n\nRecurrent refractory\u002Fprogressive inflammatory myopathy:\n\n1. Meet the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (including DM, PM, ASS and NM);\n2. Positive myositis antibody;\n3. Patients with muscle involvement had an MMT-8 score of less than 142 and abnormal findings on at least two of the following five core measures (PhGA, PtGA, extra-muscular disease activity score ≥2; HAQ total score ≥0.25; Muscle enzyme levels were 1.5 times the upper limit of the normal range); Or MMT-8≥142 with active interstitial lung disease (HRCT suggests ground glass exudation);\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept\n5. Definition of progressive: myositis aggravation or rapid progression of interstitial pneumonia.\n\nNote: Clauses 4 and 5 satisfy one or the other.\n\nRecurrent\u002Frefractory ANCA-associated vasculitis:\n\n1. Meet the 2022ACR\u002FEULAR diagnostic criteria for ANCA vasculitis, including microscopic polyvasculitis, granulomatous polyvasculitis, and eosinophilic granulomatous polyvasculitis.\n2. Anca-associated antibody positive (MPO-ANCA or PR3-ANCA positive);\n3. Birmingham vasculitis activity score (BVAS) ≥15 points (total 63 points), indicating vasculitis disease activity;\n4. Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.\n\nRecurrent refractory\u002Fcatastrophic antiphospholipid syndrome:\n\n1. Meet the diagnostic criteria for primary antiphospholipid syndrome as revised in Sydney 2006;\n2. Positive titers of phospholipid antibodies (IgG\u002FIgM of LA, B2GP1 or acL, more than two positive tests within 12 weeks);\n3. Definition of relapse resistance: standard therapy with warfarin anticoagulant or replacement vitamin K antagonists (i.e., maintenance of the INR required for treatment) or with standard therapeutic dose of low molecular weight heparin (LMWH), as well as treatment of recurrent thrombosis with past hormones and cyclophosphamide;\n4. Catastrophic antiphospholipid syndrome needs to meet the following four criteria: (1) involvement of three or more organs, systems and\u002For tissues; (2) Symptoms appear within 1 week; (3) Histologically confirmed obstruction of small blood vessels in at least one organ or tissue; (4) aPL was positive.\n\nNote: Clauses 3 and 4 satisfy one or the other.\n\nExclusion Criteria:\n\n1. People with severe drug allergy or allergic constitution;\n2. the presence or suspicion of fungal, bacterial, viral or other infections that cannot be controlled or require treatment;\n3. Subjects with central nervous system disorders (excluding pre-existing epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis as a result of the disease);\n4. Patients with cardiac dysfunction;\n5. Subjects with congenital immunoglobulin deficiency;\n6. History of malignant tumor in recent five years;\n7. Subjects with end-stage renal failure;\n8. Subjects with hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb) positive and peripheral blood HBV DNA titer higher than the upper limit of detection; Hepatitis C virus (HCV) antibody positive and peripheral blood HCV RNA positive; Human immunodeficiency virus (HIV) antibody positive; Syphilis positive;\n9. Mental illness and severe cognitive impairment;\n10. Participants who had participated in other clinical trials within 3 months before enrollment;\n11. The duration of use of immunosuppressants that have therapeutic effects on the disease before enrollment was within five half-lives or biologics within four weeks;\n12. A woman who is pregnant or planning to become pregnant;\n13. The investigators believe that there are also subjects who could not be included in the study for other reasons.",{"count":454,"type":22},[91],"An exploratory clinical study of the safety and efficacy of YTS109 cell injection in subjects with recurrent\u002Frefractory autoimmune disease",[193,167,195,196,197,27],"2024-08-27",{"date":597,"type":38},"2024-08-29",{"date":599,"type":38},"2024-04-24",{"date":601,"type":22},"2026-04-21",{"name":205,"class":151},{"id":604,"slug":605,"hasResults":12,"nctId":606,"briefTitle":607,"officialTitle":608,"acronym":4,"eligibilityCriteria":609,"healthyVolunteers":16,"sex":17,"minAge":484,"maxAge":159,"enrollmentInfo":610,"targetDuration":4,"studyType":58,"phases":611,"briefSummary":612,"conditions":613,"keywords":4,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":614,"lastUpdatePostDateStruct":615,"startDateStruct":617,"completionDateStruct":619,"leadSponsor":621,"locationsCount":46},"100557281","functional-analysis-of-salivary-glands-and-correlation-with-sialoscintigraphy-in-sjogrens-syndrome-100557281","NCT06536075","Functional Analysis of Salivary Glands and Correlation With Sialoscintigraphy in Sjogren's Syndrome","Functional Analysis and Antigen Presentation in Striated Ductal Cells of Salivary Glands and Correlation With Sialoscintigraphy in Patients and Animal Models of Sjogren's Syndrome","Inclusion Criteria:\n\n* Nomogram: no sicca symptoms\n* Sicca: already receiving sialoscintigraphy\n\nExclusion Criteria (generally):\n\n* pregnancy\n* breast feeding\n* HIV\n* cancer with active treatment\n\n(for nomogram)\n\n* chronic illness needed regular follow-up\n* Use anti-histamine, diuretics, anti-depressants, psychotropic medications, anxiolytics or NSAIDs that interfering saliva secretion\n* smoking in recent one year\n* Positive profiles for anti-SSA or anti-ENA",{"count":57,"type":22},[91],"Sjögren's syndrome is a complex autoimmune disorder. The investigators hypothesize that striated ductal cells may function as non-professional antigen-presenting cells in Sjögren's syndrome. However, there are currently no established methods to assess the functional status of striated ductal cells or their relationship with clinical presentations. To address this knowledge gap, the investigators aim to investigate the potential of sialoscintigraphy, a non-invasive imaging technique, to evaluate the functional status of striated ductal cells. The sodium iodide symporter (NIS), predominantly expressed in striated ductal cells, facilitates the transport of technetium-99m, a radiotracer used in sialoscintigraphy. The investigators hypothesize that the expression level of NIS, as evaluated through sialoscintigraphy, may serve as an indicator of striated ductal cell function and potentially correlate with clinical manifestations in Sjögren's syndrome. However, the literature and our preliminary data lead us to hypothesize that age and the specific major salivary gland being evaluated may introduce confounding factors in the interpretation of sialoscintigraphy results. The investigators therefore proposed to 1) establish a nomogram of sialoscintigraphy stratified by age and specific salivary glands. The investigators will recruit healthy volunteers to receive sialoscintigraphy for the nomogram; 2) associate the expression level of NIS in the striated ductal cells from the major salivary glands with sialoscintigraphy, markers of antigen presentation, and disease manifestations of Sjögren's syndrome. The outcomes will help further applications of sialoscintigraphy in Sjögren's syndrome and formulate hypotheses to explore the pathological mechanisms underlying Sjögren's syndrome.",[27],"2024-08-04",{"date":616,"type":38},"2024-08-06",{"date":618,"type":38},"2023-09-01",{"date":620,"type":22},"2025-08-01",{"name":622,"class":101},"National Taiwan University Hospital",{"id":624,"slug":625,"hasResults":12,"nctId":626,"briefTitle":627,"officialTitle":627,"acronym":628,"eligibilityCriteria":629,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":19,"enrollmentInfo":630,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":632,"conditions":633,"keywords":635,"overallStatus":219,"whyStopped":4,"lastUpdateSubmitDate":640,"lastUpdatePostDateStruct":641,"startDateStruct":643,"completionDateStruct":645,"leadSponsor":647,"locationsCount":4},"100556886","diagnostic-interest-of-the-buccal-schirmer-test-in-xerostomia-during-sjgrens-syndrome-xerodiag-100556886","NCT06530940","Diagnostic Interest of the Buccal Schirmer Test in Xerostomia During Sjögren's Syndrome: XERODIAG","XERODIAG","Inclusion Criteria:\n\n* Included patients meet the following criteria:\n* age over 18 years\n* diagnosis of Sjogren's syndrome meeting the ACR\u002FEULAR 2016 criteria.\n\nExclusion Criteria:\n\n* These include:\n* Cognitive or dementia disorders\n* Pregnancy",{"count":631,"type":22},180,"Xerostomia is a common and very bothersome manifestation that impairs the quality of life in Sjogren's syndrome. Its diagnosis mainly relies on the measurement of salivary flow (SF). Performing this test is unpleasant for the patient, lacks precision, can be influenced by certain conditions, and requires good patient cooperation. Other alternatives such as the buccal Schirmer test can be used. The aim of this study is to demonstrate the non-inferiority of the buccal Schirmer test compared to SF measurement. This is a diagnostic study comparing a group of patients (n=90) with Sjogren's syndrome (SS) and normal SF (≥0.1 ml\u002Fminute) to a group of patients with SS and decreased SF (\\\u003C0.1 ml\u002Fminute).",[27,67,634],"Diagnosis",[636,637,638,639],"xerostomia","sjogren's syndrom","salivary flow","oral schirmer test","2024-07-31",{"date":642,"type":38},"2024-08-02",{"date":644,"type":22},"2024-08-19",{"date":646,"type":22},"2024-12-31",{"name":648,"class":101},"University Tunis El Manar",{"id":650,"slug":651,"hasResults":12,"nctId":652,"briefTitle":653,"officialTitle":653,"acronym":4,"eligibilityCriteria":654,"healthyVolunteers":12,"sex":17,"minAge":54,"maxAge":4,"enrollmentInfo":655,"targetDuration":656,"studyType":23,"phases":4,"briefSummary":657,"conditions":658,"keywords":659,"overallStatus":34,"whyStopped":4,"lastUpdateSubmitDate":662,"lastUpdatePostDateStruct":663,"startDateStruct":665,"completionDateStruct":667,"leadSponsor":669,"locationsCount":46},"100546964","reliability-validity-and-responsiveness-of-the-turkish-version-of-eating-assessment-tool-10-for-patients-with-primer-sjgrens-syndrome-100546964","NCT06401811","Reliability, Validity, and Responsiveness of the Turkish Version of Eating Assessment Tool-10 for Patients With Primer Sjögren's Syndrome","Inclusion Criteria:\n\n* Patients diagnosed with Primary Sjögren's Syndrome\n* 18 years or older\n\nExclusion Criteria:\n\n* Patients with Secondary Sjögren's Syndrome,\n* Patients who are diagnosed with other uncontrolled\u002Fclinically important diseases (chronic obstructive pulmonary disease, congestive heart failure, endocrine system diseases, neurological, psychological diseases, etc.),\n* Individuals who do not agree to participate in the study and do not give written consent will be excluded from the study.",{"count":317,"type":22},"3 Months","Evaluations will be made by researchers following the guidance of individuals with primary Sjögren's Syndrome who receive diagnosis, routine medical care, and treatment management.\n\nIn addition, for the reliability of the Turkish Eating Assessment Tool-10, the Turkish Eating Assessment Tool-10 will be repeated on patients at least one-fifth of the number of individuals included, after one week.\n\nFor the sensitivity of the scale, an exercise that is routinely applied in the Rheumatological Rehabilitation Unit of Hacettepe University Faculty of Physical Therapy and Rehabilitation will be invited and after 3 months, the same evaluations as applied in the first measurement will be made again on individuals at least one-fifth of the number of individuals included.",[27],[660,661],"Primer Sjogren's Syndrome","swallowing disorder","2024-06-24",{"date":664,"type":38},"2024-06-25",{"date":666,"type":38},"2024-06-04",{"date":668,"type":22},"2024-11-30",{"name":670,"class":101},"Kahramanmaras Sutcu Imam University"]