[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"inflammatory-myositis\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:inflammatory-myositis":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,71,100],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":4},"100616096","early-phase-1-clinical-study-of-bct301-cell-injection-therapy-for-refractory-autoimmune-diseases-100616096",false,"NCT07301164","Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases","A Study of BCT301 (Anti-CD19 Chemically Induced Pluripotent Stem Cell (CiPSC)-Derived CAR-iT Cells) Therapy for Refractory Autoimmune Diseases","Inclusion Criteria:\n\nGeneral Inclusion Criteria\n\n1. Voluntarily sign the informed consent form.\n2. Male or female, aged 18-80 years (inclusive), with a body weight ≥40 kg.\n3. Female participants of childbearing potential and male participants with female partners of childbearing potential must use medically approved contraceptive methods or practice abstinence during the treatment period and for at least 6 months after the end of the treatment. Female participants of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to enrollment and must not be breastfeeding.\n4. Participants currently receiving one or more of the following treatments at stable doses: glucocorticoids, antimalarials, immunosuppressants:\n\n   1. If the participant is receiving glucocorticoid therapy, the following conditions must be met: the maximum dose at screening and during the screening period is 30 mg\u002Fday of prednisone (or equivalent). The dose must have been stable for ≥7 days prior to screening, and adjustments during the screening period must not exceed 5 mg\u002Fday of prednisone (or equivalent);\n   2. If the participant is receiving antimalarials and\u002For conventional immunosuppressants: the treatment must have been initiated ≥12 weeks prior to screening. The dose must have been stable for ≥8 weeks prior to screening and remain stable during the screening period;\n   3. If biological agents (belimumab, telitacicept, rituximab, etc.) were used prior to the screening period, a washout period of at least 5 half-lives must be completed before screening.\n5. Peripheral blood B cells must show positive CD19 expression as detected by flow cytometry.\n\nDisease-Specific Inclusion Criteria\n\n1\\. Systemic Lupus Erythematosus (SLE)\n\n1. Meet the 2019 European League Against Rheumatism (EULAR)\u002FAmerican College of Rheumatology (ACR) classification criteria for SLE.\n2. Have moderate to severe disease activity at screening, with a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2000) score \\>6.\n3. Have inadequate response to conventional therapy or experience disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n4. Have positive serological autoantibody tests: positive antinuclear antibodies (ANAs) and\u002For anti-ds-DNA antibodies and\u002For anti-Sm antibodies.\n\n2\\. Systemic Sclerosis (SSc)\n\n1. Meet the 2013 EULAR\u002FACR classification criteria for SSc.\n2. Fulfill either (a) or (b) below:\n\n   1. Inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n   2. Disease progression: skin progression with a modified Rodnan Skin Score (mRSS) ≥10; and\u002For interstitial lung disease evidenced by ground-glass opacities on high-resolution computed tomography (HRCT); a decline in forced vital capacity (FVC) ≥10%, or a decline in FVC ≥5% accompanied by a decline in diffusing capacity for carbon monoxide (DLCO) ≥15%.\n3. Have positive SSc-related autoantibodies. 3. Antiphospholipid Syndrome (APS)\n\n1\\) Meet the 2006 Sydney criteria for primary antiphospholipid syndrome. 2) Have medium to high titers of antiphospholipid antibodies (lupus anticoagulant \\[LA\\], anti-β2-glycoprotein 1 \\[β2GP1\\] IgG\u002FIgM, or anti-cardiolipin \\[aCL\\] IgG\u002FIgM); 3) Fulfill either (a) or (b) below:\n\n1. Receiving standard treatment with warfarin or alternative vitamin K antagonists (maintaining target international normalized ratio \\[INR\\]), or standard therapeutic doses of low molecular weight heparin (LMWH), and\u002For glucocorticoids and immunosuppressants\u002Fbiologics (e.g., cyclophosphamide, cyclosporine, tacrolimus, rituximab, etc.).\n2. Meet all four criteria for catastrophic APS:\n\ni) Involvement of three or more organs, systems, and\u002For tissues; ii) Development of manifestations within one week; iii) Histopathological confirmation of small vessel occlusion in at least one organ or tissue; iv) Positive antiphospholipid antibodies (aPL).\n\n4\\. Inflammatory Myopathy (IM)\n\n1. Meet the 2017 EULAR\u002FACR classification criteria for inflammatory myopathy (including dermatomyositis, polymyositis, anti-synthetase syndrome, and immune-mediated necrotizing myopathy).\n2. Have positive myositis-specific autoantibodies.\n3. For participants with muscle involvement: a Manual Muscle Test-8 (MMT-8) score \\\u003C142, and at least two of the following five core abnormalities: Physician Global Assessment ≥2, Patient Global Assessment ≥2, or extramuscular disease activity score ≥2; Health Assessment Questionnaire (HAQ) total score ≥0.25; muscle enzyme levels ≥1.5 times the upper limit of normal; or MMT-8 ≥142 but with active interstitial lung disease (ground-glass opacities on HRCT).\n\n5\\. Sjögren's Syndrome (SS)\n\n1. Meet the 2016 ACR\u002FEULAR classification criteria for Sjögren's syndrome.\n2. Have a EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥5.\n3. Have positive anti-SSA\u002FRo antibodies.\n4. Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n\n6\\. Anti-Neutrophil Cytoplasmic Antibody (ANCA)-Associated Vasculitis (AAV)\n\n1. Meet the 2022 ACR\u002FEULAR classification criteria for ANCA-associated vasculitis (AAV), including microscopic polyangiitis, granulomatosis with polyangiitis, and eosinophilic granulomatosis with polyangiitis.\n2. Have a history of or currently positive ANCA.\n3. Have a Birmingham Vasculitis Activity Score (BVAS) ≥15 (total score 63).\n4. Have inadequate response to conventional therapy or disease relapse after remission. Conventional therapy includes glucocorticoids (at full or pulse doses), two or more immunosuppressants, or biologic agents for at least 6 months, including cyclophosphamide, mycophenolate mofetil, cyclosporine, tacrolimus, azathioprine, leflunomide, methotrexate, belimumab, telitacicept, and rituximab.\n\nExclusion Criteria:\n\nStudy participants who meet any of the following criteria will be excluded from the study:\n\n1. Any medical condition that, in the opinion of the investigator, would contraindicate participation in the study, such as a life-threatening illness.\n2. Decreased organ function reserve not attributable to the primary disease:\n\n   a) Neutrophil count \\\u003C1×10⁹\u002FL; lymphocyte count \\\u003C0.3×10⁹\u002FL; hemoglobin \\\u003C70 g\u002FL; platelet count \\\u003C50×10⁹\u002FL; b) Alanine aminotransferase (ALT) \\>3 × upper limit of normal (ULN); aspartate aminotransferase (AST) \\>3 × ULN; total bilirubin \\>2 × ULN; c) Creatinine clearance \\\u003C40 mL\u002Fmin; estimated glomerular filtration rate (eGFR) \\\u003C30 mL\u002Fmin\u002F1.73 m²; or serum creatinine \\>2.5 mg\u002FdL; d) Left ventricular ejection fraction (LVEF) \\\u003C45% as measured by echocardiography; e) Oxygen saturation \\\u003C92% on room air.\n3. History of alcohol or substance abuse within the past 24 weeks.\n4. History of malignancy other than B-cell lymphoma.\n5. Presence of infections including human immunodeficiency virus (HIV), hypogammaglobulinemia, T-cell deficiency, syphilis, chronic hepatitis B or C, or severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2).\n6. Known active tuberculosis (TB) infection or active bacterial infection.\n7. History of myocardial infarction, coronary angioplasty or stenting, unstable angina, clinically significant arrhythmia, or other clinically significant cardiac disease within 6 months prior to screening.\n8. Symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to screening, except in cases of antiphospholipid syndrome (APS).\n9. History of severe allergic reaction to any component of cellular therapy or other immunotherapeutic agents.\n10. Prior organ transplant requiring ongoing immunosuppressive therapy.\n11. Concurrent participation in another clinical trial that may interfere with disease assessment or study treatment.\n12. Prior treatment with CD19- and\u002For BCMA-targeted therapy or any CAR-T cell product; except in cases where prior therapy is deemed to have clearly failed (e.g., no response, short duration of response, or disease progression) as assessed by the investigator, the current disease state warrants the study treatment, and there is no clear evidence that toxicity from prior therapy would compromise the safety of the current study.\n13. Severe psychiatric disorder or significant cognitive impairment.\n14. Pregnancy, lactation, or planned pregnancy.\n15. Any other condition that, in the judgment of the investigator, would make the participant unsuitable for enrollment in this clinical trial.","ALL","18 Years","80 Years",{"count":20,"type":21},10,"ESTIMATED","INTERVENTIONAL",[24],"EARLY_PHASE1","This study primarily involves the use of BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells, for the treatment of patients with refractory autoimmune diseases, aiming to evaluate its safety, tolerability, and dose-limiting toxicities(DLT), and to determine the recommended therapeutic dose for further investigation. Additionally, the study assesses the efficacy of BCT301 cell injection in refractory autoimmune diseases, as well as the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in study participants.",[27,28,29,30,31,32],"System Lupus Erythematosus","Systemic Sclerosis (SSc)","Inflammatory Myositis","Antiphospholipid Syndrome","ANCA Associated Vasculitis","Sjogren Syndrome","NOT_YET_RECRUITING","2025-12-09",{"date":36,"type":37},"2025-12-24","ACTUAL",{"date":39,"type":21},"2025-12-11",{"date":41,"type":21},"2028-12-31",{"name":43,"class":44},"Peking University Third Hospital","OTHER",{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":50,"acronym":51,"eligibilityCriteria":52,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":53,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":56,"conditions":57,"keywords":4,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":61,"lastUpdatePostDateStruct":62,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":70},"100474179","follow-up-of-patients-with-inflammatory-myopathies-associated-with-a-biobank-100474179","NCT05454527","Follow-up of Patients With Inflammatory Myopathies Associated With a Biobank","Follow-up of a Cohort of Patients With Inflammatory Myopathies Associated With a Biobank: MASC 2 Project (Myositis, Muscles, DNA\u002FRNA Serum Cells)","MASC2","Inclusion Criteria:\n\n* Age ≥ 18 years\n* Suspicion of Myositis defined according to reference classifications: Dermatomyositis (DM), polymyositis (PM) defined as early as 1975 by Bohan and Peter, inclusion myositis (IM) according to the criteria of Griggs et al, 1995 and autoimmune necrotizing myopathy (ANM) by Hoogendijk et al, in 2004 and iatrogenic (e.g. drug-induced) myositis.\n* No opposition from patients to the use of their data\n* Signature of consents for the constitution of the biobank and the genetic analyses\n\nExclusion Criteria:\n\n* Patients under AME\n* Patients under legal protection",{"count":54,"type":21},4000,"OBSERVATIONAL","Myositis are rare diseases for which the development of a cohort associated with a bank of biological samples (biobank) will allow for the conduct of researches to better delineate the underlying pathophysiology and find cures. This prospective cohort of patients with myositis will allow for identification of factors favouring the occurrence of myositis, whether they are constitutional (genetic) or acquired (environmental or drug). Different subgroups of myositis used for prognostication will be identified based on clinico-demographical variables, the nature of the organs involved beyond peripheral muscles (cardiac, diaphragm) and biomarkers abnormalities",[29,58,59],"Idiopathic Inflammatory Myositis","Drug-induced Inflammatory Myositis","RECRUITING","2025-04-22",{"date":63,"type":37},"2025-04-23",{"date":65,"type":37},"2022-10-26",{"date":67,"type":21},"2057-10-26",{"name":69,"class":44},"Assistance Publique - Hôpitaux de Paris",2,{"id":72,"slug":73,"hasResults":11,"nctId":74,"briefTitle":75,"officialTitle":76,"acronym":77,"eligibilityCriteria":78,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":79,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":81,"conditions":82,"keywords":86,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":90,"lastUpdatePostDateStruct":91,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":99},"100565491","rare-autoimmune-self-management-programme-development-100565491","NCT06642870","Rare AutoImmune SElf-management Programme Development","Rare Autoimmune Self-management Programme Development","RAISE","Inclusion Criteria:\n\n1. Diagnosis of a rare rheumatic condition made by hospital doctor or secondary care: including lupus, systemic vasculitis, myositis, Sjogren syndrome (participant self-report)\n2. Ability to give informed consent (with translation support if needed)\n\nExclusion Criteria:\n\n\\-",{"count":80,"type":21},360,"The rare autoimmune rheumatic diseases (RAIRDs) are life-long multi-system diseases that are life or organ threatening. RAIRDs can impair quality of life similar to chronic diseases such as heart failure. The aim of the study is to explore content and structure of a support programme for people with RAIRDs in focus groups and survey meetings.",[83,84,29,28,85,32],"Systemic Lupus Erthematosus","Systemic Vasculitis","ANCA Associated Vasculitis (AAV)",[87,88,89],"Rare autoimmune rheumatic diseases","Self-management","Psychological support","2024-10-14",{"date":92,"type":37},"2024-10-15",{"date":94,"type":21},"2024-10",{"date":96,"type":21},"2026-04",{"name":98,"class":44},"University of the West of England",1,{"id":101,"slug":102,"hasResults":11,"nctId":103,"briefTitle":104,"officialTitle":104,"acronym":105,"eligibilityCriteria":106,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":107,"enrollmentInfo":108,"targetDuration":4,"studyType":55,"phases":4,"briefSummary":110,"conditions":111,"keywords":117,"overallStatus":60,"whyStopped":4,"lastUpdateSubmitDate":121,"lastUpdatePostDateStruct":122,"startDateStruct":124,"completionDateStruct":126,"leadSponsor":128,"locationsCount":99},"100561659","role-of-platelets-in-the-pathophysiology-of-systemic-lupus-100561659","NCT06593041","ROLE of PLATELETS in the PATHOPHYSIOLOGY of SYSTEMIC LUPUS","PLAQUETTOLUP","Inclusion Criteria:\n\n* Patients between 18 and 70 years of age\n* Patient affiliated to a health insurance scheme (beneficiary or beneficiary's beneficiary)\n* Patient able to understand the aims and risks of research\n* Patient having signed and dated an informed consent form\n* Patient for whom the diagnosis of at least one of the following pathologies has been confirmed:\n* Systemic lupus erythematosus meeting ACR\u002FEULAR 20195 classification criteria.\n* Systemic scleroderma meeting ACR\u002FEULAR 20136 classification criteria.\n* ANCA vasculitis according to EULAR\u002FACR 2022.7-9 classification criteria.\n* Inflammatory myositis according to EULAR\u002FACR 201710 classification criteria.\n* Gougerot-Sjögren syndrome according to EULAR\u002FACR 2016 classification criteria11.\n* Rheumatoid arthritis according to ACR\u002FEULAR 201012 classification criteria.\n\nExclusion Criteria:\n\n* Patient in exclusion period (determined by a previous or current study)\n* Inability to give patient informed consent (patient in emergency or immediate life-threatening situation)\n* Patient under court protection\n* Patient under guardianship or curatorship","70 Years",{"count":109,"type":21},450,"Blood platelets, well known for their role in hemostasis, are abnormally activated in patients suffering from systemic lupus erythematosus (SLE), but also from other immunomediated diseases (scleroderma, vasculitis, myositis, Gougerot-Sjögren's and rheumatoid arthritis) in cases of high disease activity. Once activated, platelets express adhesion molecules such as P-selectin on their surface, enabling them to interact physically with immune cells. In a recent work, we identified that activated platelets from lupus patients interact with regulatory T cells and block their regulatory function, thus participating in the deregulated activation of the immune system in SLE. In addition, inhibition of platelet-immune cell interactions by an anti-P-selectin antibody improved LES symptoms in two mouse models.\n\nThe aim of this work is to investigate other potential platelet-immune cell interactions in patients with SLE, in comparison with other autoimmune diseases (systemic scleroderma, ANCA vasculitides, inflammatory myositis, Gougerot-Sjögren syndrome and rheumatoid arthritis).\n\nThis study could lead to a better understanding of the role of platelets in the pathophysiology of autoimmune diseases, identify new biomarkers of activity, and assess the potential of new therapeutic avenues in these diseases, such as platelet targeting.",[112,113,114,29,115,116],"Systemic Lupus Erythematosus","Systemic Scleroderma Meeting","ANCA Vasculitis","Gougerot-Sjögren Syndrome","Rheumatoid Arthritis",[118,119,120],"PLATELETS","PATHOPHYSIOLOGY","SYSTEMIC LUPUS","2024-09-09",{"date":123,"type":37},"2024-09-19",{"date":125,"type":37},"2024-01-09",{"date":127,"type":21},"2029-01-09",{"name":129,"class":44},"University Hospital, Strasbourg, France"]