[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"leadSponsorName\":\"Groupe français d'étude des Maladies Inflammatoires de loeil\",\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:":121},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,4,0,[8,44,73,98],{"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":22,"studyType":23,"phases":4,"briefSummary":24,"conditions":25,"keywords":27,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100620229","upadacitinib-in-giant-cell-arteritis-gca-with-active-large-vessel-involvement-100620229",false,"NCT07354906","Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.","Prospective Observational Study Evaluating the Efficacy and Safety of Upadacitinib in Giant Cell Arteritis (GCA) With Active Large-vessel Involvement.","TILT2","Inclusion Criteria:\n\nPatients aged over 18 years; Signed informed consent; Affiliation with the French national social security system; Diagnosis of newly diagnosed or relapsing GCA according to the 2022 ACR\u002FEULAR criteria; Active aortitis related to GCA demonstrated by imaging (CT angiography, MR angiography, and\u002For PET-CT); Indication for treatment with an anti-JAK agent within the scope of the marketing authorization for GCA: failure of, intolerance to, or contraindication to tocilizumab therapy; No contraindication to JAK inhibitors.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding (for women of childbearing potential, a negative serum pregnancy test will be required); History of severe immunosuppression, HIV infection, hepatitis C virus (HCV), or positive hepatitis B surface antigen (HBsAg); Non-response to or intolerance of a previous anti-JAK treatment; Positive QuantiFERON test (QFT-TB Gold In-Tube) indicating active tuberculosis (latent tuberculosis under treatment for at least 3 weeks may be included); Receipt of live vaccines within the 3 months preceding treatment initiation; History of malignancy within the past 5 years; Severe renal impairment (creatinine clearance \\\u003C 30 mL\u002Fmin\u002F1.73 m²); Hepatic dysfunction defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) levels ≥ 5 times the upper limit of normal;\n\nAbnormal blood counts:\n\nPlatelets \\\u003C 50 × 10³\u002Fmm³; Neutropenia \\\u003C 1,000\u002Fmm³; Hemoglobin \\\u003C 8 g\u002FdL; History of thromboembolic disease; History of severe cardiovascular disease.","ALL","18 Years",{"count":20,"type":21},80,"ESTIMATED","24 Months","OBSERVATIONAL","Participants will be followed as part of the usual management of their disease. No modifications will be made (no additional visits, examinations, or questionnaires). The safety and well-being of participants will therefore remain unchanged.\n\nThe participant will be informed about the study during one of their routine care visits. The information will be provided by the investigator, and the participant's non-opposition to participation in the study will be obtained.\n\nThe participant will continue to be followed as part of their usual care.\n\nData will then be collected from the participant's medical record (including medical reports, original laboratory test results, imaging reports and medical examinations, and nursing records) for the period of participation in the research, solely for the purpose of meeting the objectives of the research.\n\nThe data collected will consist of information from the patient's medical record as part of their routine follow-up and will be strictly necessary to address the primary and secondary objectives of the study. The following data will be collected: demographic data (age, sex, weight, height); clinical data (medical history, diagnosed condition, disease activity), treatments, biological data, imaging data, and adverse events. No genetic data will be collected as part of the study. There will be no transfer of data abroad, and no additional questionnaires, examinations, or visits will be added by the research.",[26],"Giant Cell Arteritis (GCA)",[28,29,30],"Giant Cell Arteritis (GCA) .","Upadacitinib","Efficacy","NOT_YET_RECRUITING","2026-01-12",{"date":34,"type":35},"2026-01-21","ACTUAL",{"date":37,"type":21},"2026-03-01",{"date":39,"type":21},"2030-03-30",{"name":41,"class":42},"Groupe français d'étude des Maladies Inflammatoires de loeil","OTHER",14,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":54,"conditions":55,"keywords":57,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":64,"lastUpdatePostDateStruct":65,"startDateStruct":67,"completionDateStruct":69,"leadSponsor":71,"locationsCount":72},"100611748","ustekinumab-in-behets-syndrome-study-100611748","NCT07244614","Ustekinumab in BEhçet's Syndrome STudy","Observational Study Assessing the Biosimilar of Ustekinumab in Active Mucocutaneous Behçet's Syndrome Refractory or Intolerant to Conventional Approaches","USBEST","Inclusion Criteria:\n\n* Age ≥ 18 years old;\n* Non-opposition to study;\n* Use of contraceptive measures;\n* Fulfillment of the international classification criteria for Behçet's disease, revised in 2013;\n* Indication for ustekinumab or apremilast within the standard of care of mucocutaneous Behçet's syndrome\n* For ustekinumab cohort: Active mucocutaneous manifestations of Behçet's syndrome that are recurrent, intolerant or refractory to colchicine or apremilast, including oral ulcers, genital ulcers, skin lesions (e.g., pseudofolliculitis), and\u002For inflammatory arthralgia\u002Farthritis.\n* For apremilast cohort: recurrent active mucocutaneous manifestations of Behçet's syndrome naïve of treatment.\n\nDue to its fluctuant characteristics over time, active oral ulcers are defined as two or more oral ulcers over the month preceding inclusion and must have occurred at least three times in the previous 12-month period, despite the previous use of colchicine\n\nExclusion Criteria:\n\n* Pregnancy;\n* Previous treatment failure to ustekinumab;\n* Contraindications to ustekinumab, such as:\n* Active chronic infections (e.g., active tuberculosis, replicative hepatitis B, HIV, etc.) or malignancies;\n* Live vaccins in the past 3 months;\n* Severe renal impairment (CrCl \\\u003C30mL\u002Fmin\u002F1,73m²)\n* Severe hepatic impairment (transaminases 5 times the upper normal values)\n* Severe cytopenias:\n\nPlatelets \\\u003C 50 x 103\u002Fmm3 Neutrophils \\\u003C 1000\u002Fmm3 Hemoglobin \\\u003C 8 g\u002FDl",{"count":53,"type":21},208,"This non-interventional study is an observational cohort with parallel groups aiming primarily to describe the success of biosimilar of ustekinumab in Behçet's syndrome in whom conventional approaches have failed or are not suitable well tolerated, and then to compare with patients receiving apremilast within routine care.\n\nUstekinumab previously prescribed subcutaneously at 90 mg on Week 0, 4, 12 and 20 within the standard of care.\n\nFollowing non-opposition to participate, patients data will be collected, which will comprise data of the 3-month interval medical visits, except for the first month of treatment, in which the short-term tolerance of treatments is usually assessed (ie, baseline visit, then week 4, 12, 24, 36 and 52). Clinical examination, biological tests and relevant clinical scores (BDCAF, BSAS and PhGA) data that were performed within routine care. No changes to patients' usual care will be made (no additional visits, additional examinations or questionnaires), their safety and well-being remaining therefore unchanged. Data will be collected from the participant's medical record (containing medical reports and examinations, biological tests, nursing records, etc.), for the period of participation in the research, with the only purpose of meeting the objectives of the research. Data will be collected using an electronic 'eCRF observation book on the REDCap platform. The following data will be collected: demographic data (age, sex, weight, height); clinical data (history of the disease, pathology diagnosed, activity of the pathology), treatments, biological data, adverse events. No genetic data will be collected as part of the study. No data will be transferred abroad. No additional questionnaires, examinations or visits will be added by the research. Activity indexes for BS will be calculated as part of routine care. The number, duration and intensity of oral ulcers of patients will be verified by the nurse or the site investigator according to the routine care.\n\nPatients' data with active mucocutaneous Behçet's manifestations with an indication of starting apremilast within standard of care (according to AMM and PNDS) will be retrospectively collected in order to establish a retrospective cohort for comparative purposes.",[56],"Behçet's Syndrome (BS)",[58,59,60,61,62],"Behçet's syndrome","biosimilar","ustekinumab","refractory","apremilast","RECRUITING","2025-11-17",{"date":66,"type":35},"2025-11-24",{"date":68,"type":35},"2025-09-01",{"date":70,"type":21},"2029-12-31",{"name":41,"class":42},11,{"id":74,"slug":75,"hasResults":11,"nctId":76,"briefTitle":77,"officialTitle":77,"acronym":78,"eligibilityCriteria":79,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":80,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":81,"conditions":82,"keywords":85,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":92,"completionDateStruct":94,"leadSponsor":96,"locationsCount":97},"100574295","prospective-observational-study-evaluating-the-safety-and-efficacy-of-immunomodulatory-therapies-in-refractory-inflammatory-and-autoimmune-diseases-100574295","NCT06757426","Prospective Observational Study Evaluating the Safety and Efficacy of Immunomodulatory Therapies in Refractory Inflammatory and Autoimmune Diseases","ARIES","Inclusion Criteria:\n\n1. Patients over 18 years\n2. Enrolled in the French national social security system\n3. Diagnosis of an inflammatory\u002Fautoimmune disease meeting internationally accepted classification criteria;\n4. Clinical activity of their disease with biological and\u002For radiological signs, refractory to conventional therapeutic lines, requiring a new treatment as an addition or replacement according to clinical judgment.\n5. No formal contraindication to the new therapeutic class.\n\nExclusion Criteria:\n\n1. Pregnancy or breast-feeding (for women of childbearing potential, a negative serum pregnancy test will be required);\n2. History of severe immunosuppression, HIV or HBsAg positive.\n3. Positive QuantiFERON test result (QFT-TBGIn-Tube) for active tuberculosis (latent tuberculosis under treatment may be included).\n4. Have received live vaccines in the 3 months preceding the start of treatment.\n5. History of malignant tumor within the last 5 years.\n6. Severe renal insufficiency (creatinine clearance \\\u003C30mL\u002Fmin\u002F1.73m²)\n7. Liver dysfunction defined by aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 5 times the upper limit of normal.\n8. Blood count abnormality:\n\n   * Platelets \\\u003C 50 x 103\u002Fmm3\n   * Neutropenia \\\u003C 1000\u002Fmm3\n   * Hemoglobin \\\u003C 8 g\u002FdL",{"count":20,"type":21},"Inflammatory and\u002For autoimmune diseases represent a very broad group of diseases with highly variable clinical features, including - but not limited to - systemic connectivites and vasculitides. As these diseases are rare and heterogeneous, it is difficult to conduct randomized clinical trials in this setting. Refractory cases are therefore treated with drugs that are already available on the market for other indications in more frequent and clinically homogeneous diseases, such as inflammatory rheumatism and haematological malignancies.\n\nPrescribing treatments from other specialties (e.g. rheumatology and oncohaematology) is a reality in the clinical practice of internists and immunologists, often representing an excellent solution for difficult-to-treat inflammatory and\u002For autoimmune diseases. As these molecules are prescribed without the availability of standardized data, it is essential to collect them prospectively to better characterize the efficacy and tolerability of these new therapeutic options in severe inflammatory and\u002For autoimmune diseases.",[83,84],"Autoimmune Diseases","Inflammatory Diseases",[86,87,88],"autoimmune","inflamatory disease","Refraction","2024-12-26",{"date":91,"type":35},"2025-01-03",{"date":93,"type":21},"2025-01-15",{"date":95,"type":21},"2028-07-15",{"name":41,"class":42},17,{"id":99,"slug":100,"hasResults":11,"nctId":101,"briefTitle":102,"officialTitle":103,"acronym":104,"eligibilityCriteria":105,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":106,"targetDuration":4,"studyType":23,"phases":4,"briefSummary":107,"conditions":108,"keywords":110,"overallStatus":63,"whyStopped":4,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":115,"completionDateStruct":117,"leadSponsor":119,"locationsCount":120},"100536914","tocilizumab-in-aortitis-in-gca-tilt-100536914","NCT06271018","TocILizumab in aorTitis in GCA (TILT)","Prospective, Observational Study Assessing Safety and Efficacy of Biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) With Active Aortitis","TILT","Inclusion Criteria:\n\n* Patients ≥18 years\n* Signed informed consent\n* Affiliation with the French national social security system\n* Adequate and effective contraceptive measures\n* For women of childbearing age, a negative serum pregnancy test.\n* Diagnosis of GCA according to 2022 ACR\u002FEULAR criteria\n* Active newly diagnosed or relapsing Aortitis related to GCA proved by imaging (Tep-scan, angio-CT or magnetic resonance imaging angiography)\n* No neoplasia\n* No contraindication to Tocilizumab\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding ;\n* History of severe immunosuppression, HIV or HBsAg positive\n* Non response or intolerance to previous therapy with tocilizumab\n* Positive QuantiFERON test result (QFT-TBGIn-Tube)\n* Have received live vaccines within 3 months prior to the start of the trial\n* History of malignancy in the last 5 years\n* Severe renal impairment (creatinine clearance \\\u003C30mL\u002Fmin\u002F1.73m²)\n* Liver dysfunction defined as aspartate transaminase (AST) or alanine transaminase (ALT) levels ≥ 5 at the upper limit of normal\n* Blood count abnormality:\n\n  * Platelet count \\\u003C 50 x 10.3\u002Fmm3\n  * Neutropenia \\\u003C 1000\u002Fmm3\n  * Hemoglobin \\\u003C 8 g\u002Fdl",{"count":20,"type":21},"This is a french multicenter observational study assessing safety and efficacy of biosimilar of Tocilizumab in Giant Cell Arteritis (GCA) with active aortitis, including 14 reference centers from the Groupe d'Etude Français des vascularites des gros vaisseaux (GEFA).\n\nGiant Cell Arteritis (GCA), formerly known as temporal arteritis, is the most common form of systemic vasculitis in patients aged ≥ 50 years. GCA is defined by granulomatous arteritis that affects large#sized and medium#sized blood vessels with a predisposition to affect the cranial arteries. Aortitis accounted for more than 50% of GCA patients with the new imaging techniques. Aortitis is typically diagnosed using imaging tests such as magnetic resonance imaging (MRI) or Computed Tomography (CT) scans. Aortitis is an inflammation of the aorta, leading to a range of symptoms such as fever, weight loss, fatigue, and chest pain. In severe cases, aortic aneurysms or aortic dissection can occur, which can be life-threatening.\n\nMultiple reports have demonstrated the presence of abnormal pro-inflammatory cytokine production in large-vessel vasculitis patients, particularly those with GCA, including interleukin-1 (IL-1), IL-6, IL-18, tumor necrosis factor-α (TNF-α), and interferon-γ, by T lymphocytes and macrophages. IL-6 has been implicated as a crucial cytokine in the pathogenesis of aortitis and targeting its signaling has shown promising results in treating the condition. IL-6 inhibitors such as tocilizumab have been found to effectively reduce disease activity and improve clinical outcomes in GCA patients.\n\nThe GIACTA study (GiAnt cell arteritis roActemra (tocilizumab) study) was a randomized, double-blind, placebo-controlled trial that evaluated the efficacy and safety of tocilizumab in the treatment of GCA. The study included 251 patients with newly diagnosed or relapsing GCA and found that treatment with tocilizumab significantly increased the proportion of patients who achieved sustained remission from GCA at 52 weeks, compared to placebo. Additionally, tocilizumab was associated with a lower incidence of disease flares and a reduced need for glucocorticoid therapy.\n\nFollowing the positive results of the GIACTA study, tocilizumab was approved for the treatment of GCA in adults with active disease, including aortitis, who have not responded to glucocorticoids, or for whom glucocorticoid therapy is not appropriate, by regulatory agencies around the world, including the US Food and Drug Administration and the European Medicines Agency.\n\nHowever, the efficacy of IL-6 inhibitors on aorta inflammation as assessed by modern and powerful imaging techniques has never been specifically studied in GCA.\n\nThis observational study will provide important informations on the impact of Tyenne® (tocilizumab) associated with short term low dose steroids on clinical manifestations and vessel inflammation and damage in aortitis of GCA.",[109,26],"Aortitis",[26,109,111],"Tocilizumab","2024-12-18",{"date":114,"type":35},"2024-12-20",{"date":116,"type":35},"2024-03-27",{"date":118,"type":21},"2028-03-27",{"name":41,"class":42},1,""]