[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"autoimmune-rheumatologic-disease\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:autoimmune-rheumatologic-disease":31},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,51,85,112],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":26,"conditions":27,"keywords":32,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":39,"lastUpdatePostDateStruct":40,"startDateStruct":43,"completionDateStruct":45,"leadSponsor":47,"locationsCount":50},"100629321","phase-1-controlling-hyperactive-immunity-with-long-lived-lymphocytes-100629321",false,"NCT07473154","Controlling Hyperactive Immunity With Long-lived Lymphocytes","Phase I\u002FII Study of QEL-005 in Patients With Diffuse Cutaneous Systemic Sclerosis (dcSSc) and in Patients With Difficult to Treat Rheumatoid Arthritis (D2TRA).","CHILL","Inclusion Criteria:\n\n* Participants must be at least 18 years of age at the time of signing the informed consent.\n* Up to date vaccination status and no planned vaccinations for post 3 months infusion\n* Adequate haematological, liver and renal function\n* Willing to undergo annual influenza vaccination\n* Willing to enter a 15-year follow-up\n* Eastern Cooperative Oncology Group (ECOG) performance status grade \\\u003C 3\n* Able and willing to use a highly effective method of contraception\n* Stable dose of steroid prior to screening\n\nSpecific inclusion criteria for participants with difficult to treat rheumatoid Arthritis (D2TRA) only:\n\n* Diagnosis of Rheumatoid Arthritis (RA) per 2010 ACR-EULAR criteria\n* Diagnosis of D2TRA per 2021 EULAR criteria\n* Evidence of clinically active disease a defined by validated clinical or laboratory results consistent with standard definitions of active RA\n* Evidence of inflammation in target joints used for the DAS28 CRP assessment\n\nSpecific inclusion criteria for participants with diffuse cutaneous systemic sclerosis (dcSSc) only:\n\n* Diagnosis of dcSSc as per the 2013 ACR-EULAR criteria\n* Serologically positive for antinuclear antibodies\n* Failure to respond sufficiently to immunomodulatory disease modifying anti-rheumatic drugs (DMARDs).\n* Skin involvement with a total modified Rodnan Skin Score of at least 15\n* Evidence of lung fibrosis based on imaging or pulmonary function testing\n* Evidence of active disease based on a validated SSc activity assessment\n\nExclusion Criteria:\n\n* Presence of a significant medical condition(s), or clinically significant laboratory abnormality\n* History or concern of autoimmune diseases other than those under study\n* Active infection, or recurrent chronic infection requiring intervention\n* Immunodeficiency or receiving immunoglobulin replacement therapy\n* Past or current infection with hepatitis B or C, tuberculosis, syphilis, or HIV\n* Clinically significant cardiac dysfunction or severe pulmonary impairment\n* Use of investigational agents within a pre-defined period prior to study screening\n* Received a previous cell therapy\n* Received certain B cell related experimental therapies in a clinical trial with the past year\n* Any solid organ, bone marrow or stem cell transplant\n* History of malignancy in the past 5 years\n* Receiving prohibited medication that cannot be stopped at screening","ALL","18 Years",{"count":20,"type":21},16,"ESTIMATED","INTERVENTIONAL",[24,25],"PHASE1","PHASE2","This study is a Phase 1\u002F2, open-label clinical trial to test an experimental treatment called QEL-005 in adults with two autoimmune conditions: diffuse cutaneous systemic sclerosis (dcSSc) and difficult-to-treat rheumatoid arthritis (D2TRA). The main goals are to find out whether QEL-005 is safe, how well people tolerate it, and whether it may help reduce disease activity or improve symptoms.\n\nQEL-005 is made from a participant's own white blood cells (autologous cells). These cells are collected and then changed in a laboratory using genetic methods to create specialized immune cells called CAR-T regulatory cells that target a protein on B cells called CD19. These modified cells are then given back to the participant by intravenous (IV) infusion.\n\nTo take part, eligible participants will first have a procedure called leukapheresis, where some of their white blood cells are removed from the blood. The study team will use these cells to manufacture QEL005. After QEL005 is ready, participants will receive an IV infusion of their modified cells, stay in hospital overnight for monitoring, and will then be followed closely in the clinic.\n\nThroughout the trial, participants will have regular safety checks, which may include blood tests, imaging scans, questionnaires about symptoms and daily functioning, and biopsies taken from involved tissues, to help understand how QEL005 is working in the body. Detailed follow up will be for 1 year after QEL-005 infusion, and there is long-term follow up for a total of 15 years, which is standard for cell therapies. The information from this Phase 1\u002F2 study will help determine an appropriate dose and dosing schedule of QEL005 for future studies.",[28,29,30,31],"Diffuse Cutaneous Systemic Sclerosis","Rheumatoid Arthritis (RA)","Systemic Sclerosis (SSc)","Autoimmune Rheumatologic Disease",[33,34,35,36,37],"Regulatory T cells","Autologous","Genetically modified cells","Treg","Chimeric antigen receptor (CAR)","RECRUITING","2026-06-29",{"date":41,"type":42},"2026-06-30","ACTUAL",{"date":44,"type":42},"2026-04-10",{"date":46,"type":21},"2028-08",{"name":48,"class":49},"Quell Therapeutics Limited","INDUSTRY",6,{"id":52,"slug":53,"hasResults":11,"nctId":54,"briefTitle":55,"officialTitle":56,"acronym":57,"eligibilityCriteria":58,"healthyVolunteers":59,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":4,"studyType":22,"phases":64,"briefSummary":66,"conditions":67,"keywords":68,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":74,"lastUpdatePostDateStruct":75,"startDateStruct":77,"completionDateStruct":79,"leadSponsor":81,"locationsCount":84},"100612378","phase-4-immunogenicity-and-safety-of-menb-vaccine-in-pediatric-patients-with-autoimmune-rheumatic-diseases-100612378","NCT07252804","Immunogenicity and Safety of MenB Vaccine in Pediatric Patients With Autoimmune Rheumatic Diseases","Short- and Long-Term Immunogenicity and Safety of Meningococcal Group B Vaccine in Children and Adolescents With Autoimmune Rheumatic Diseases","MENB-PARD","Inclusion Criteria:\n\n* Participants must be between 2 and 25 years of age with no prior history of MenB-4C vaccination.\n* Patients classified with autoimmune rheumatic diseases will be invited to participate.\n\nPatients with JIA must meet the classification criteria of the International League of Associations for Rheumatology; patients with JSLE, the American College of Rheumatology criteria; and those with JDM, the Bohan \\& Peter criteria.\n\nExclusion Criteria:\n\n* History of any reaction or hypersensitivity to any vaccine component;\n* Acute infectious disease and\u002For fever at the time of vaccination;\n* Pregnancy or breastfeeding;\n* History of Guillain-Barré syndrome;\n* Participants who fail to attend evaluation visits and laboratory sample collection; hospitalization at study inclusion;\n* Transfusion of blood products within 6 months prior to the study;\n* Application of any vaccine within one month prior to each dose.",true,"2 Years","25 Years",{"count":63,"type":21},263,[65],"PHASE4","The goal of this clinical trial is to evaluate the humoral immunogenicity of the meningococcal B vaccine (MenB-4C) in pediatric patients with autoimmune rheumatic diseases (ARDs), compared to age- and sex-matched non-immunosuppressed controls.\n\nThe main questions it aims to answer are:\n\n* To assess the influence of treatment on the response to the MenB-4C vaccine in patients with ARDs;\n* To evaluate the impact of the MenB-4C vaccine on disease activity in patients with ARDs;\n* To evaluate the safety of the MenB-4C vaccine in pediatric patients with ARDs and controls.\n* To evaluate the association between physical activity levels and immunogenicity after vaccination.\n\nParticipants will:\n\nReceive the MenB-4C vaccine (Bexsero©), administered intramuscularly in the deltoid muscle, in a 2-dose schedule (0.5 mL each), 1 month apart.\n\nAll participants will have blood samples collected immediately before vaccination at the baseline visit (D0), then receive the first vaccine dose on the same day (D0). The second dose will be administered 4 weeks after the first dose (D28). Blood samples will be collected on D0, D28, and D56. A final sample will be collected one year after the last dose (D208) to evaluate the persistence of immune response.\n\nAt study entry and one month after each dose, patients will also be assessed for clinical and laboratory disease activity using disease-specific indices and scores.\n\n* Juvenile Systemic lupus erythematosus (JSLE): Systemic lupus erythematosus disease activity index 2000 (SLEDAI-2K) (CBC, anti-dsDNA, complement, urinalysis, protein\u002Fcreatinine ratio)\n* Juvenile Idiopatic Arthritis (JIA): Juvenile Arthritis Disease Activity Score (JADAS) (ESR, CRP)\n* Juvenile dermatomyositis (JDM): Manual Muscle Testing (MMT) e Childhood Myositis Assessment Scale (CMAS): (CPK, transaminases, LDH)\n\nResearcher will also perform analysis in:\n\nHumoral immunogenicity will be assessed using serum bactericidal activity (SBA) assay with exogenous complement (baby rabbit, Pel Freez) against four test strains: H44\u002F76 (fHBP), 5\u002F99 (NadA), NZ98\u002F254 (PorA), and M10713 (NHBA), from blood samples collected at D0, D28, D56, and D208. SBA assays will be conducted at the Immunology Center of the Adolfo Lutz Institute, São Paulo. Exogenous complement will be added to serially diluted serum samples, followed by the addition of a bacterial suspension. The humoral response rate induced by the vaccine, or seroconversion, will be defined by the bactericidal titer (the dilution that results in 50% bacterial killing within 60 minutes compared to the control), with titers ≥ 1:4 considered bactericidal. The geometric mean titers will be calculated using the exponential of the mean of the log-transformed concentrations.\n\nImmunosuppressive treatments (NSAIDs, prednisone\u002Fprednisolone, intra-articular steroids, hydroxychloroquine, methotrexate, azathioprine, leflunomide, cyclosporine, tacrolimus, mycophenolate mofetil, and biologics \\[anti-TNF, tocilizumab, abatacept, belimumab, rituximab\\]) will be recorded sistematicaly.\n\nPhysical activity levels will be assessed using validated, age-appropriate methods.",[31],[69,70,71,72,73],"Meningococcal B vaccine","Autoimmune Rheumatic Diseases","Rheumatology","Pediatric Rheumatology","Infectious Disease Prevention","2026-04-14",{"date":76,"type":42},"2026-04-20",{"date":78,"type":42},"2026-02-19",{"date":80,"type":21},"2027-12-30",{"name":82,"class":83},"University of Sao Paulo General Hospital","OTHER",2,{"id":86,"slug":87,"hasResults":11,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":91,"eligibilityCriteria":92,"healthyVolunteers":59,"sex":17,"minAge":60,"maxAge":61,"enrollmentInfo":93,"targetDuration":4,"studyType":22,"phases":95,"briefSummary":96,"conditions":97,"keywords":98,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":104,"lastUpdatePostDateStruct":105,"startDateStruct":107,"completionDateStruct":109,"leadSponsor":110,"locationsCount":111},"100612377","phase-4-safety-and-immunogenicity-of-pcv20-in-pediatric-patients-with-autoimmune-rheumatic-diseases-100612377","NCT07252791","Safety and Immunogenicity of PCV20 in Pediatric Patients With Autoimmune Rheumatic Diseases","Safety and Immunogenicity of the 20-valent Pneumococcal Conjugate Vaccine (PCV20) in Children and Adolescents With Autoimmune Rheumatic Diseases","PCV20-PARD","Inclusion Criteria:\n\n* Age 2-25 years\n* Diagnosis of JIA, jSLE, or JDM by validated classification criteria\n* Clinically stable\n* Informed consent\u002Fassent\n\nExclusion Criteria:\n\n* Acute infection or fever at vaccination\n* Severe allergic reaction to vaccine components\n* Recent blood transfusion (\\\u003C6 months)\n* Other vaccine within 4 weeks prior at the time of inclusion\n* Pregnancy or breastfeeding\n* Prior PCV20",{"count":94,"type":21},114,[65],"This clinical trial evaluates the immunogenicity (humoral and cellular) and safety of the 20-valent pneumococcal conjugate vaccine (PCV20) in children, adolescents, and young adults aged 2-25 years with autoimmune rheumatic diseases (ARDs). All participants will receive PCV20 according to prior vaccine history. Antibody titers, opsonophagocytic activity, cellular immune responses, and adverse events will be measured up to 6 months post-vaccination. Effects of immunosuppressive therapy and physical activity levels related vaccine response will also be assessed.",[31],[99,100,101,72,102,103],"Pneumococcal Conjugate Vaccine","PCV20","Autoimmune Diseases","Immunogenicity","Vaccine Safety","2026-03-02",{"date":106,"type":42},"2026-03-04",{"date":108,"type":42},"2026-01-16",{"date":80,"type":21},{"name":82,"class":83},1,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":116,"acronym":117,"eligibilityCriteria":118,"healthyVolunteers":11,"sex":17,"minAge":119,"maxAge":18,"enrollmentInfo":120,"targetDuration":4,"studyType":122,"phases":4,"briefSummary":123,"conditions":124,"keywords":4,"overallStatus":38,"whyStopped":4,"lastUpdateSubmitDate":143,"lastUpdatePostDateStruct":144,"startDateStruct":146,"completionDateStruct":148,"leadSponsor":150,"locationsCount":111},"100431799","conception-of-a-diagnosis-prognosis-and-therapeutic-decision-tool-for-patients-with-autoimmunity-and-inflammation-100431799","NCT04902807","Conception of a Diagnosis, Prognosis and Therapeutic Decision Tool for Patients With Autoimmunity and Inflammation","ATRACTion","Inclusion Criteria for controls (patients relatives and unrelated subjects):\n\n* Individuals aged\\\u003C18 y\u002Fo.\n* Individuals \\> 6 kg\n* Individuals not affected by an immune-related disease or not affected by cancer\n* Individuals whose parents have signed an enlightened consent.\n\nInclusion criteria for patients\n\n* Individuals with health insurance.\n* Patients treated at Necker hospital with PIDs and autoimmunity\u002Finflammation related to known genetic defects (cytopenia, Enteropathy Inflammatory bowel disease (IBD), Systemic Lupus Erythematosus (SLE), Juvenile Idiopathic Arthritis (JIA), Familial Hemophagocytic Lymphohistiocytosis (FHL), chronic EBV infection associated (Ca-EBV) with EBV-infected T and\u002For Natural Killer (NK) cells and with a high risk to develop macrophage activation syndrome similar to FHL. See table below for diagnosis inclusion criteria.\n* Individuals aged\\\u003C18 y\u002Fo.\n* Individuals \\> 9 kg\n* Patients whose parents have signed an enlightened consent.\n\nExclusion Criteria:\n\n* Intake of antibiotics within 2 weeks prior inclusion\n* Absence of parent's or child consent form\n* Cytotoxic cancer treatments\n* antiviral treatments (HIV, hepatitis …)\n* Short term life-threatening conditions\n* Individuals placed under judicial protection","1 Year",{"count":121,"type":21},500,"OBSERVATIONAL","The main objective of this study is to generate diagnosis and therapeutic-decision tools through the identification of molecular causes of PIDs with autoimmunity\u002Finflammation and the variability in disease outcome at the transcriptional level using a combination of omics signatures (transcriptomics, epigenomics, proteomics, metagenomics, metabolomics and lipidomics).",[125,126,101,127,128,129,130,31,131,132,133,134,135,136,137,138,139,140,141,142],"Autoimmune Lymphoproliferative Syndrome","Autoimmune Cytopenia","Autoimmune Anemia","Autoimmune Thrombocytopenia","Autoimmune Hepatitis","Autoimmune Diabetes","Systemic Lupus Erythematosus","Juvenile Idiopathic Arthritis","Hemophagocytic Lymphohistiocytoses","EBV Lymphoproliferation","RAS-Associated Autoimmune Leucoproliferative Disease","Primary Immunodeficiency","APECED","IPEX","BENTA","Enteropathy, Autoimmune","Combined Immunodeficiency","IBD","2025-09-02",{"date":145,"type":42},"2025-09-08",{"date":147,"type":42},"2021-09-07",{"date":149,"type":21},"2026-06",{"name":151,"class":152},"Institut National de la Santé Et de la Recherche Médicale, France","OTHER_GOV"]