[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100574295":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":12,"locations":19,"responsibleParty":244,"collaborators":10,"id":246,"slug":247,"hasResults":248,"nctId":249,"briefTitle":250,"officialTitle":250,"acronym":251,"eligibilityCriteria":252,"healthyVolunteers":248,"sex":253,"minAge":254,"maxAge":10,"enrollmentInfo":255,"targetDuration":10,"studyType":258,"phases":10,"briefSummary":259,"conditions":260,"keywords":263,"overallStatus":267,"whyStopped":10,"lastUpdateSubmitDate":268,"lastUpdatePostDateStruct":269,"startDateStruct":272,"completionDateStruct":274,"leadSponsor":276,"locationsCount":277},{"fullName":5,"class":6},"Groupe français d'étude des Maladies Inflammatoires de loeil","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":10},"Adult patients with immune-mediated inflammatory disease refractory to conventional lines of therapy",null,"Adult patients with immune-mediated inflammatory disease refractory to conventional lines of therapy.",[13],{"name":14,"role":15,"phone":16,"phoneExt":17,"email":18},"DAVID SAADOUN, Professor","CONTACT","+33142178042","+33","david.saadoun@aphp.fr",[20,37,51,65,79,93,104,118,132,146,160,174,188,203,214,223,233],{"facility":21,"status":10,"city":22,"state":10,"zip":23,"country":24,"countryCode":25,"cosmosGeoPoint":26,"geoPoint":31,"contacts":32},"Clinique Axium - Aix-en-provence","Aix-en-Provence","13100","France","FR",{"type":27,"coordinates":28},"Point",[29,30],5.44973,43.5283,{"lat":30,"lon":29},[33],{"name":34,"role":15,"phone":35,"phoneExt":10,"email":36},"Thomas SENÉ, MD","+33442957153","dr.sene.axium@almaviva-sante.com",{"facility":38,"status":10,"city":39,"state":10,"zip":40,"country":24,"countryCode":25,"cosmosGeoPoint":41,"geoPoint":45,"contacts":46},"CH Simone Veil de BLOIS","Blois","41000",{"type":27,"coordinates":42},[43,44],1.32912,47.59432,{"lat":44,"lon":43},[47],{"name":48,"role":15,"phone":49,"phoneExt":10,"email":50},"Bertrand LIOGER, MD","+33254556365","liogerb@ch-blois.fr",{"facility":52,"status":10,"city":53,"state":10,"zip":54,"country":24,"countryCode":25,"cosmosGeoPoint":55,"geoPoint":59,"contacts":60},"CHU Caen Normandie","Caen","14000",{"type":27,"coordinates":56},[57,58],-0.35912,49.18585,{"lat":58,"lon":57},[61],{"name":62,"role":15,"phone":63,"phoneExt":10,"email":64},"Hubert DE BOYSSON, Professor","+33231064678","deboysson-h@chu-caen.fr",{"facility":66,"status":10,"city":67,"state":10,"zip":68,"country":24,"countryCode":25,"cosmosGeoPoint":69,"geoPoint":73,"contacts":74},"CH du Mans","Le Mans","72037",{"type":27,"coordinates":70},[71,72],0.20251,48.0021,{"lat":72,"lon":71},[75],{"name":76,"role":15,"phone":77,"phoneExt":10,"email":78},"Pierre LOZAC'H, MD","+33243432799","plozach@ch-lemans.fr",{"facility":80,"status":10,"city":81,"state":10,"zip":82,"country":24,"countryCode":25,"cosmosGeoPoint":83,"geoPoint":87,"contacts":88},"APHM_Hôpital La Conception","Marseille","13005",{"type":27,"coordinates":84},[85,86],5.38107,43.29695,{"lat":86,"lon":85},[89],{"name":90,"role":15,"phone":91,"phoneExt":10,"email":92},"Pierre-André JARROT, MD","+33491383522","Pierre.JARROT@ap-hm.fr",{"facility":94,"status":10,"city":81,"state":10,"zip":95,"country":24,"countryCode":25,"cosmosGeoPoint":96,"geoPoint":98,"contacts":99},"APHM_Hôpital Nord","13915",{"type":27,"coordinates":97},[85,86],{"lat":86,"lon":85},[100],{"name":101,"role":15,"phone":102,"phoneExt":10,"email":103},"Brigitte Granel, Professor","+33491968711","Brigitte.granel@ap-hm.fr",{"facility":105,"status":10,"city":106,"state":10,"zip":107,"country":24,"countryCode":25,"cosmosGeoPoint":108,"geoPoint":112,"contacts":113},"GHSIF Melun","Melun","77000",{"type":27,"coordinates":109},[110,111],2.65356,48.5457,{"lat":111,"lon":110},[114],{"name":115,"role":15,"phone":116,"phoneExt":10,"email":117},"Nabil BELFEKI, MD","+33181741818","nabil.belfeki@ghsif.fr",{"facility":119,"status":10,"city":120,"state":10,"zip":121,"country":24,"countryCode":25,"cosmosGeoPoint":122,"geoPoint":126,"contacts":127},"GHI Le Raincy Montfermeil","Montfermeil","93370",{"type":27,"coordinates":123},[124,125],2.57913,48.8982,{"lat":125,"lon":124},[128],{"name":129,"role":15,"phone":130,"phoneExt":10,"email":131},"Azeddine DELLAL, MD","+33141708000","azeddine.dellal@ght-gpne.fr",{"facility":133,"status":10,"city":134,"state":10,"zip":135,"country":24,"countryCode":25,"cosmosGeoPoint":136,"geoPoint":140,"contacts":141},"CHU Nantes - Hotel-Dieu","Nantes","44000",{"type":27,"coordinates":137},[138,139],-1.55336,47.21725,{"lat":139,"lon":138},[142],{"name":143,"role":15,"phone":144,"phoneExt":10,"email":145},"Olivier Espitia, Professor","+33240083379","Olivier.espitia@chu-nantes.fr",{"facility":147,"status":10,"city":148,"state":10,"zip":149,"country":24,"countryCode":25,"cosmosGeoPoint":150,"geoPoint":154,"contacts":155},"CHU Rouen_Hôpital Charles Nicolle","Rouen","76000",{"type":27,"coordinates":151},[152,153],1.09932,49.44313,{"lat":153,"lon":152},[156],{"name":157,"role":15,"phone":158,"phoneExt":10,"email":159},"Mathilde LECLERQ, MD","+332 32 88 73 96","Mathilde.Leclercq@chu-rouen.fr",{"facility":161,"status":10,"city":162,"state":10,"zip":163,"country":24,"countryCode":25,"cosmosGeoPoint":164,"geoPoint":168,"contacts":169},"Clinique Saint-Exupéry","Saint-Exupéry","31400",{"type":27,"coordinates":165},[166,167],-0.10243,44.62612,{"lat":167,"lon":166},[170],{"name":171,"role":15,"phone":172,"phoneExt":10,"email":173},"Martin Michaud, MD","+33561173330","Martin.MICHAUD@clinique-saint-exupery.com",{"facility":175,"status":10,"city":176,"state":10,"zip":177,"country":24,"countryCode":25,"cosmosGeoPoint":178,"geoPoint":182,"contacts":183},"CHRU de Tours_Hôpital Bretenneau","Tours","37000",{"type":27,"coordinates":179},[180,181],0.70398,47.39484,{"lat":181,"lon":180},[184],{"name":185,"role":15,"phone":186,"phoneExt":10,"email":187},"Julie Magnant, MD","+33218370878","J.MAGNANT@chu-tours.fr",{"facility":189,"status":10,"city":190,"state":191,"zip":192,"country":24,"countryCode":25,"cosmosGeoPoint":193,"geoPoint":197,"contacts":198},"APHP_Hopital Lariboisière","Paris","Île-de-France Region","75010",{"type":27,"coordinates":194},[195,196],2.3488,48.85341,{"lat":196,"lon":195},[199],{"name":200,"role":15,"phone":201,"phoneExt":10,"email":202},"Chloé Comarmond, MD","+33149958127","chloe.comarmondortoli@aphp.fr",{"facility":204,"status":10,"city":190,"state":191,"zip":205,"country":24,"countryCode":25,"cosmosGeoPoint":206,"geoPoint":208,"contacts":209},"APHP_Hôpital St Antoine","75012",{"type":27,"coordinates":207},[195,196],{"lat":196,"lon":195},[210],{"name":211,"role":15,"phone":212,"phoneExt":10,"email":213},"Arsene Mekinian, Professor","+33149282153","arsene.mekinian@aphp.fr",{"facility":215,"status":10,"city":190,"state":191,"zip":216,"country":24,"countryCode":25,"cosmosGeoPoint":217,"geoPoint":219,"contacts":220},"APHP_ Hôpital Pitié-Salpêtrière","75013",{"type":27,"coordinates":218},[195,196],{"lat":196,"lon":195},[221],{"name":222,"role":15,"phone":16,"phoneExt":10,"email":18},"David Saadoun, Professor",{"facility":224,"status":10,"city":190,"state":191,"zip":225,"country":24,"countryCode":25,"cosmosGeoPoint":226,"geoPoint":228,"contacts":229},"APHP_Hôpital Bichat","75018",{"type":27,"coordinates":227},[195,196],{"lat":196,"lon":195},[230],{"name":231,"role":15,"phone":232,"phoneExt":10,"email":10},"Karim Sacre, Professor","+330140258705",{"facility":234,"status":10,"city":190,"state":191,"zip":235,"country":24,"countryCode":25,"cosmosGeoPoint":236,"geoPoint":238,"contacts":239},"APHP_Hopital Ambroise Paré","92100",{"type":27,"coordinates":237},[195,196],{"lat":196,"lon":195},[240],{"name":241,"role":15,"phone":242,"phoneExt":10,"email":243},"Salim TRAD, Professor","+33149095496","salim.trad@aphp.fr",{"type":245,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100574295","prospective-observational-study-evaluating-the-safety-and-efficacy-of-immunomodulatory-therapies-in-refractory-inflammatory-and-autoimmune-diseases-100574295",false,"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","ALL","18 Years",{"count":256,"type":257},80,"ESTIMATED","OBSERVATIONAL","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.",[261,262],"Autoimmune Diseases","Inflammatory Diseases",[264,265,266],"autoimmune","inflamatory disease","Refraction","NOT_YET_RECRUITING","2024-12-26",{"date":270,"type":271},"2025-01-03","ACTUAL",{"date":273,"type":257},"2025-01-15",{"date":275,"type":257},"2028-07-15",{"name":5,"class":6},17]