[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100447354":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":27,"centralContacts":28,"locations":27,"responsibleParty":38,"collaborators":27,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":27,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":27,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":27,"overallStatus":59,"whyStopped":27,"lastUpdateSubmitDate":60,"lastUpdatePostDateStruct":61,"startDateStruct":64,"completionDateStruct":66,"leadSponsor":68,"locationsCount":27},{"fullName":5,"class":6},"Peking Union Medical College Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Medium dose group (Adalimumab plus medium dose oral glucocorticosteroid)","EXPERIMENTAL","Patients will be given adalimumab with 30mg daily prednisone or equivalent with a fixed slow tapering plan.",[13],"Drug: Adalimumab plus different doses of oral glucocorticosteroid",{"label":15,"type":16,"description":17,"interventionNames":18},"High dose group (Adalimumab plus high dose oral glucocorticosteroid)","ACTIVE_COMPARATOR","Patients will be given adalimumab with 60mg daily prednisone or equivalent with a fixed slow tapering plan.",[13],[20],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":25},"DRUG","Adalimumab plus different doses of oral glucocorticosteroid","A loading dose of 80mg adalimumab will be given subcutaneously and then change to 40mg adalimumab every two weeks. Medium dose oral glucocorticosteroid (30mg\u002Fd prednisone or equivalent) will be given to the experimental dose group and high dose oral glucocorticosteroid (60mg\u002Fd prednisone or equivalent) will be given to the high dose group.",[15,9],[26],"Humira, prednisone",null,[29,34],{"name":30,"role":31,"phone":32,"phoneExt":27,"email":33},"Hang Song, MD","CONTACT","+8615600612346","songhang_pumch@163.com",{"name":35,"role":31,"phone":36,"phoneExt":27,"email":37},"Chan Zhao, MD","+8613810454083","zhaochan@pumch.cn",{"type":39,"investigatorFullName":27,"investigatorTitle":27,"investigatorAffiliation":27,"oldNameTitle":27,"oldOrganization":27},"SPONSOR","100447354","phase-4-efficacy-and-safety-of-adalimumab-plus-medium-dose-oral-glucocorticosteroid-for-refractory-behets-uveitis-100447354",false,"NCT05105347","Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis","Efficacy and Safety of Adalimumab Plus Medium Dose Oral Glucocorticosteroid for Refractory Behçet's Uveitis, Compared With Adalimumab Plus High Dose Oral Glucocorticosteroid, a Non-inferior, Multi-center, Randomized Controlled Trial.","Inclusion Criteria:\n\n* Behçet's disease (BD) patients fulfilling the International Criteria for Behçet's disease (ICBD) published in 2013 with recent recurrence of pan- or posterior uveitis\n* The patient should be on ≥10mg\u002Fd oral prednisone or equivalent\n\nExclusion Criteria:\n\n* Previous treatment with TNFα inhibitors within 3 months\n* Pregnancy, breast feeding women\n* Malignancy\n* Heart failure\n* Demyelinating diseases\n* Renal impairment (creatinine \\> 1.5 mg\u002Fdl)\n* Depression or other psychic disorders\n* History of acute or chronic inflammatory joint or autoimmune disease\n* Patients with severe extra-ocular involvement other than oral\u002Fgenital ulcer and skin involvement\n* Organ or bone marrow transplant recipient, cardiac failure \\> NYHA III\n* Acute liver disease with ALT or SGPT 2x above normal\n* White blood cell count \\\u003C 3500\u002Fmm\\^3\n* Platelet count \\\u003C 100000\u002Fmm\\^3\n* Hgb \\\u003C 8.5g\u002Fdl\n* T-SPOT TB: ≥200 SFCs per 10\\^6 PBMC\n* Active peptic ulcer, systemic or local infection, moderate to severe osteoporosis or other contraindications of intermediate dose corticosteroids\n* Other severe ocular diseases or intraocular surgery within 3 months\n* Media opacity precluding a clear view of the fundus\n* Positive screen test for HBV, HCV, HIV infection or syphilis\n* Body weight \\\u003C45 kg\n* Alcohol abuse or drug abuse\n* Mental impairment\n* Uncooperative attitude","ALL","18 Years","65 Years",{"count":51,"type":52},130,"ESTIMATED","INTERVENTIONAL",[55],"PHASE4","This study is a multi-center randomized non-inferiority study that aims to observe the short-term (3 months) efficacy and safety of adalimumab plus medium-dose glucocorticosteroid (30mg\u002Fd prednisone or equivalent) with slow tapering for recurrent Behçet's uveitis (BU) attack compared with adalimumab plus high-dose glucocorticosteroid (60mg\u002Fd prednisone or equivalent) with slow tapering.",[58],"Uveitis","NOT_YET_RECRUITING","2021-11-01",{"date":62,"type":63},"2021-11-03","ACTUAL",{"date":65,"type":52},"2021-11-10",{"date":67,"type":52},"2026-12-31",{"name":5,"class":6}]