[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"primary-sjgrens-syndrome\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:primary-sjgrens-syndrome":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,45,74,101],{"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":28,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":33,"lastUpdatePostDateStruct":34,"startDateStruct":37,"completionDateStruct":39,"leadSponsor":41,"locationsCount":44},"100591369","phase-2-efficacy-and-safety-of-imvt-1402-in-adult-participants-with-primary-sjogrens-disease-with-moderate-to-severe-systemic-disease-activity-100591369",false,"NCT06979531","Efficacy and Safety of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity","A Phase 2b, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Efficacy, Safety, and Tolerability of IMVT-1402 in Adult Participants With Primary Sjogren's Disease With Moderate to Severe Systemic Disease Activity","Inclusion Criteria:\n\n* Participants with a diagnosis of primary SjD for at least 12 months prior to the Screening Visit and meet classification criteria for primary SjS according to the 2016 American College of Rheumatology\u002F European League Against Rheumatism Classification Criteria for Primary Sjogren's Syndrome at the time of screening.\n* Participants with moderate to severe systemic disease activity as determined by a clinESSDAI total score ≥ 5 at the Screening Visit.\n* Participants are seropositive for antibodies to Sjogren's Syndrome A (SSA)\u002FAnti-Sjogren's Syndrome A (Ro) at the Screening Visit.\n* Participants have residual salivary flow as measured by stimulated whole salivary flow rate ≥ 0.01 milliliters per minute (mL\u002Fmin) at the Screening Visit.\n\nAdditional inclusion criteria are defined in the protocol.\n\nExclusion Criteria:\n\n* Participants with a diagnosis of secondary SjD, inadequately treated fibromyalgia, other confirmed connective tissue, rheumatic, or systemic inflammatory autoimmune disease including but not limited to, rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, dermatomyositis, or polymyositis, that in the opinion of the Investigator, is likely to interfere with the ability to assess primary SjD manifestations.\n* Participants with a history of clinically significant monoclonal gammopathy, including but not limited to monoclonal gammopathy of undetermined significance, history of multiple myeloma or non-Hodgkin's lymphoma, or have an active malignancy or history of malignancy within 5 years prior to the Screening Visit.\n\nAdditional exclusion criteria are defined in the protocol.","ALL","18 Years","74 Years",{"count":20,"type":21},180,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a Phase 2b, multicenter, randomized, double-blinded, placebo-controlled study to assess the efficacy and safety of IMVT-1402 in adult participants with moderate to severe systemic primary Sjogren's disease (SjD).",[27],"Primary Sjögren's Syndrome",[29,30,31],"Sjogren Disease","IMVT-1402","Imeroprubart","RECRUITING","2026-06-05",{"date":35,"type":36},"2026-06-08","ACTUAL",{"date":38,"type":36},"2025-06-30",{"date":40,"type":21},"2029-07",{"name":42,"class":43},"Immunovant Sciences GmbH","INDUSTRY",121,{"id":46,"slug":47,"hasResults":11,"nctId":48,"briefTitle":49,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":4,"briefSummary":55,"conditions":56,"keywords":57,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":73},"100286048","autoreactive-anti-rossa-ige-to-determine-primary-sjgrens-syndromes-disease-activity-100286048","NCT03003572","Autoreactive Anti-Ro\u002FSSA IgE To Determine Primary SjögRen's Syndrome's Disease Activity","I GET DRY","Inclusion Criteria:\n\n* Primary Sjögren's syndrome according to the American-European Consensus Criteria)\n* Informed and having signed the study consent form\n\nExclusion Criteria:\n\n* Secondary Sjögren's syndrome\n* Other systemic autoimmune disease (e.g. rheumatoid arthritis, AntiNeutrophil Antibodies (ANCA) -associated vasculitis, mixed connective tissue disease…)\n* Incapacity or refusal to sign the informed consent form\n* Incapacity or refusal to perform the follow-up examinations required by the study\n* Has received abatacept, sifalimumab, rontalizumab, anifrolumab, belimumab, Tumor Necrosis Factor (TNF) antagonists or interferon during the 6 months prior to the inclusion\n* Has any current signs or symptoms of active infection",{"count":53,"type":21},185,"OBSERVATIONAL","Primary Sjögren's syndrome (pSS) can affect various organs, sometimes leads to life-threatening conditions and is always responsible for a decreased quality of life. Its evolution is chronic, with flares and relapses, and the need for reliable biomarkers to be carried out routinely is major in patients' follow-up. Because of the existence of autoreactive immunoglobulins E (IgE) in autoimmune diseases, the recently described role for anti-Ro\u002FSSA antibodies in inducing interferon alpha (IFNα) signaling and the specific pharmacologic properties of IgE, anti-Ro\u002FSSA IgE should be an interesting biomarker to determine pSS's activity. The aim of the study is to evaluate whether the proportion of anti-Ro\u002FSSA IgE positive patients is higher in patients with active disease (i.e. Eular Sjögren Syndrome Disease Activity Index≥ 5). All consecutive patients with pSS (new or already known diagnosis) will be included, Anti-Ro\u002FSSA IgE titers will be determined, the disease's features will be collected (including Eular Sjögren Syndrome Disease Activity Index\u002FEular Sjogren's Syndrome Patient Reported Index).",[27],[58,59,60,61,62],"Sjögren's syndrome","Immunoglobulin E","Anti-Ro\u002FSSA","Autoimmune disease","Biomarker","2026-05-05",{"date":65,"type":36},"2026-05-06",{"date":67,"type":36},"2018-03-27",{"date":69,"type":21},"2027-06",{"name":71,"class":72},"Centre Hospitalier Universitaire de Saint Etienne","OTHER",8,{"id":75,"slug":76,"hasResults":11,"nctId":77,"briefTitle":78,"officialTitle":79,"acronym":4,"eligibilityCriteria":80,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":81,"enrollmentInfo":82,"targetDuration":4,"studyType":22,"phases":84,"briefSummary":86,"conditions":87,"keywords":88,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":94,"completionDateStruct":96,"leadSponsor":98,"locationsCount":100},"100437812","phase-4-the-efficacy-and-safety-of-iguratimod-igu-in-the-treatment-of-primary-sjgrens-syndrome-100437812","NCT04981145","The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome","The Efficacy and Safety of Iguratimod (IGU) in the Treatment of Primary Sjögren's Syndrome: a Multi-center, Prospective, Open Study","Inclusion Criteria:\n\n* Diagnosed with pSS by meeting the 2016 ACR\u002FEULAR Classification Criteria.\n* The patient complained of dry mouth and eyes.\n* Positive anti-SSA\u002FRo-60 antibody at screening.\n* IgG≥16 g\u002FL.\n* No hormone, immunosuppressant, biological agents or other treatments were received within 4 weeks before screening;\n* Pregnancy test of is negative. Use effective contraceptives during the trial (female)\n* Those who did not participate in any drug trial within 12 weeks before enrollment\n\nExclusion Criteria:\n\n* Pregnant or lactating or planning to get pregnant during the duration of the study.\n* Complicated with other CTD\n* Complicated with malignancy\n* mental illness, a history of alcohol abuse, immunodeficiency, uncontrolled infections, and drug or other substance abuse\n* serious systemic damage, glucocorticoids, other immunosuppressants and biological agents should be added to control the condition: Heart, liver (transaminase\u002Fbilirubin \\>1.5 times the upper normal limit), kidney (Cr≥133mmol\u002FL), lung (FVC % \\\u003C 60%), blood (white blood cell \\\u003C3×109\u002FL, HGB\\\u003C80g\u002FL, PLT\\\u003C80×109\u002FL), etc.\n* Fundus\u002Fvisual field lesions;\n* Allergic to any component of the study drug (IGU and\u002For HCQ);\n* the investigator considers the patient to be unsuitable for entry into the study","70 Years",{"count":83,"type":21},78,[85],"PHASE4","A multi-center, prospective, open-label, randomized controlled study of efficacy and safety of Iguratimod in patients with Primary Sjögren's syndrome",[27],[89,58,90],"Primary Sjögren's syndrome","Iguratimod","2024-10-11",{"date":93,"type":36},"2024-10-16",{"date":95,"type":36},"2022-01-14",{"date":97,"type":21},"2025-07",{"name":99,"class":72},"Second Affiliated Hospital, School of Medicine, Zhejiang University",1,{"id":102,"slug":103,"hasResults":11,"nctId":104,"briefTitle":105,"officialTitle":106,"acronym":107,"eligibilityCriteria":108,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":109,"targetDuration":111,"studyType":54,"phases":4,"briefSummary":112,"conditions":113,"keywords":114,"overallStatus":32,"whyStopped":4,"lastUpdateSubmitDate":117,"lastUpdatePostDateStruct":118,"startDateStruct":120,"completionDateStruct":122,"leadSponsor":124,"locationsCount":100},"100288887","the-assess-national-multi-center-prospective-cohort-100288887","NCT03040583","The ASSESS National Multi-center Prospective Cohort","Assessment of Systemic Complications (Signs) and Evolution From Patients With Sjögren's Syndrome (ASSESS)","ASSESS","Inclusion Criteria:\n\n* aged of 18 years or more\n* Primary Sjögren's Syndrome Patients who have already participated to the study ASSESS\n\nExclusion Criteria:\n\n* secondary Sjögren's Syndrome (SJ) associated with other autoimmune diseases",{"count":110,"type":21},395,"20 Years","The ASSESS national multi-center prospective cohort (Assessment of Systemic complications (Signs) and Evolution in Sjögren's Syndrome \"SS\") was set up in 2006 thanks to a grant of the French Ministry of Health. Fifteen centers for autoimmune diseases consecutively included consecutive patients with Primary Sjögren's Syndrome \"pSS\" fulfilling American-European Consensus Criteria (AECG) between 2006 and 2009. The study was approved by the Ethics Committee of Bichat Hospital in 2006. All patients gave their informed written consent. This study was followed for 5 years with the grant of the French Ministry of Health and this study will be extended for 20 years by French Society of Rheumatology (SFR). On an annual basis for a duration of 20 years, a thorough standardized paper case report form (CRF) was filled prospectively by clinicians.",[27],[115,116],"Primary Sjögren's syndrome (PSS)","auto-immune diseases","2020-03-12",{"date":119,"type":36},"2020-03-13",{"date":121,"type":4},"2016-09",{"date":123,"type":21},"2030-09",{"name":125,"class":72},"Assistance Publique - Hôpitaux de Paris"]