[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611748":3},{"organization":4,"armGroups":7,"interventions":10,"overallOfficials":10,"centralContacts":15,"locations":21,"responsibleParty":155,"collaborators":10,"id":157,"slug":158,"hasResults":159,"nctId":160,"briefTitle":161,"officialTitle":162,"acronym":163,"eligibilityCriteria":164,"healthyVolunteers":159,"sex":165,"minAge":166,"maxAge":10,"enrollmentInfo":167,"targetDuration":10,"studyType":170,"phases":10,"briefSummary":171,"conditions":172,"keywords":174,"overallStatus":78,"whyStopped":10,"lastUpdateSubmitDate":180,"lastUpdatePostDateStruct":181,"startDateStruct":184,"completionDateStruct":186,"leadSponsor":188,"locationsCount":189},{"fullName":5,"class":6},"Groupe français d'étude des Maladies Inflammatoires de loeil","OTHER",[8,12],{"label":9,"type":10,"description":11,"interventionNames":10},"Ustekinumab group",null,"patients who have received the Ustekinumab",{"label":13,"type":10,"description":14,"interventionNames":10},"Apremilast group","patients who have received the Apremilast",[16],{"name":17,"role":18,"phone":19,"phoneExt":10,"email":20},"DAVID SAADOUN, Professor","CONTACT","+33142178042","david.saadoun@aphp.fr",[22,39,53,66,76,91,104,114,128,138,146],{"facility":23,"status":24,"city":25,"state":10,"zip":10,"country":26,"countryCode":27,"cosmosGeoPoint":28,"geoPoint":33,"contacts":34},"CHU BORDEAUX Hôpital Saint-André - Service de médecine interne","NOT_YET_RECRUITING","Bordeaux","France","FR",{"type":29,"coordinates":30},"Point",[31,32],-0.58046,44.84124,{"lat":32,"lon":31},[35],{"name":36,"role":18,"phone":37,"phoneExt":10,"email":38},"Emmanuel RIBEIRO, MD","+33556795828","emmanuel.ribeiro@chu-bordeaux.fr",{"facility":40,"status":24,"city":41,"state":10,"zip":42,"country":26,"countryCode":27,"cosmosGeoPoint":43,"geoPoint":47,"contacts":48},"Service de médecine interne-APHP - Henri Mondor","Créteil","94000",{"type":29,"coordinates":44},[45,46],2.46569,48.79266,{"lat":46,"lon":45},[49],{"name":50,"role":18,"phone":51,"phoneExt":10,"email":52},"Nicolas LIMAL, Professor","+33149812076","nicolas.limal@aphp.fr",{"facility":54,"status":24,"city":55,"state":10,"zip":10,"country":26,"countryCode":27,"cosmosGeoPoint":56,"geoPoint":60,"contacts":61},"HOPITAL CROIX-ROUSSE - HCL - service de médecine interne","Lyon",{"type":29,"coordinates":57},[58,59],4.84789,45.74906,{"lat":59,"lon":58},[62],{"name":63,"role":18,"phone":64,"phoneExt":10,"email":65},"Nicolas Fournier, MD","+33 4 26 73 26 36","nicolas.fournier01@chu-lyon.fr",{"facility":67,"status":24,"city":55,"state":10,"zip":10,"country":26,"countryCode":27,"cosmosGeoPoint":68,"geoPoint":70,"contacts":71},"Hospices civils de Lyon",{"type":29,"coordinates":69},[58,59],{"lat":59,"lon":58},[72],{"name":73,"role":18,"phone":74,"phoneExt":10,"email":75},"Cecile lesort, MD","+33472110321","cecile.lesort@chu-lyon.fr",{"facility":77,"status":78,"city":79,"state":10,"zip":80,"country":26,"countryCode":27,"cosmosGeoPoint":81,"geoPoint":85,"contacts":86},"GHSIF Melun","RECRUITING","Melun","77000",{"type":29,"coordinates":82},[83,84],2.65356,48.5457,{"lat":84,"lon":83},[87],{"name":88,"role":18,"phone":89,"phoneExt":10,"email":90},"Nabil BELFEKI, MD","+33181741818","nabil.belfeki@ghsif.fr",{"facility":92,"status":24,"city":93,"state":10,"zip":10,"country":26,"countryCode":27,"cosmosGeoPoint":94,"geoPoint":98,"contacts":99},"AP-HP-Hôpital COCHIN","Paris",{"type":29,"coordinates":95},[96,97],2.3488,48.85341,{"lat":97,"lon":96},[100],{"name":101,"role":18,"phone":102,"phoneExt":10,"email":103},"Sarah Guegan, MD","+33158411809","sarah.guegan@aphp.fr",{"facility":105,"status":24,"city":93,"state":10,"zip":10,"country":26,"countryCode":27,"cosmosGeoPoint":106,"geoPoint":108,"contacts":109},"service de dermatologie - APHP - St Louis",{"type":29,"coordinates":107},[96,97],{"lat":97,"lon":96},[110],{"name":111,"role":18,"phone":112,"phoneExt":10,"email":113},"Thibault Mahevas, MD","+33142499733","thibault.mahevas@aphp.fr",{"facility":115,"status":24,"city":116,"state":10,"zip":117,"country":26,"countryCode":27,"cosmosGeoPoint":118,"geoPoint":122,"contacts":123},"CHU Rouen_Hôpital Charles Nicolle","Rouen","76000",{"type":29,"coordinates":119},[120,121],1.09932,49.44313,{"lat":121,"lon":120},[124],{"name":125,"role":18,"phone":126,"phoneExt":10,"email":127},"Mathilde LECLERQ, MD","+332 32 88 73 96","Mathilde.Leclercq@chu-rouen.fr",{"facility":129,"status":24,"city":116,"state":10,"zip":10,"country":26,"countryCode":27,"cosmosGeoPoint":130,"geoPoint":132,"contacts":133},"CHU de Rouen - service dermatologie",{"type":29,"coordinates":131},[120,121],{"lat":121,"lon":120},[134],{"name":135,"role":18,"phone":136,"phoneExt":10,"email":137},"Vivien Hebert, MD","+332326841","Vivien.hebert@chu-rouen.fr",{"facility":139,"status":140,"city":93,"state":141,"zip":142,"country":26,"countryCode":27,"cosmosGeoPoint":143,"geoPoint":145,"contacts":10},"APHP_Hopital Lariboisière","ACTIVE_NOT_RECRUITING","Île-de-France Region","75010",{"type":29,"coordinates":144},[96,97],{"lat":97,"lon":96},{"facility":147,"status":78,"city":93,"state":141,"zip":148,"country":26,"countryCode":27,"cosmosGeoPoint":149,"geoPoint":151,"contacts":152},"APHP_ Hôpital Pitié-Salpêtrière","75013",{"type":29,"coordinates":150},[96,97],{"lat":97,"lon":96},[153],{"name":154,"role":18,"phone":19,"phoneExt":10,"email":20},"David Saadoun, Professor",{"type":156,"investigatorFullName":10,"investigatorTitle":10,"investigatorAffiliation":10,"oldNameTitle":10,"oldOrganization":10},"SPONSOR","100611748","ustekinumab-in-behets-syndrome-study-100611748",false,"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","ALL","18 Years",{"count":168,"type":169},208,"ESTIMATED","OBSERVATIONAL","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.",[173],"Behçet's Syndrome (BS)",[175,176,177,178,179],"Behçet's syndrome","biosimilar","ustekinumab","refractory","apremilast","2025-11-17",{"date":182,"type":183},"2025-11-24","ACTUAL",{"date":185,"type":183},"2025-09-01",{"date":187,"type":169},"2029-12-31",{"name":5,"class":6},11]