[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100630764":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":36,"centralContacts":40,"locations":45,"responsibleParty":59,"collaborators":23,"id":62,"slug":63,"hasResults":64,"nctId":65,"briefTitle":66,"officialTitle":67,"acronym":23,"eligibilityCriteria":68,"healthyVolunteers":64,"sex":69,"minAge":70,"maxAge":23,"enrollmentInfo":71,"targetDuration":23,"studyType":74,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":48,"whyStopped":23,"lastUpdateSubmitDate":87,"lastUpdatePostDateStruct":88,"startDateStruct":91,"completionDateStruct":93,"leadSponsor":95,"locationsCount":96},{"fullName":5,"class":6},"Marmara University","OTHER",[8],{"label":9,"type":10,"description":11,"interventionNames":12},"Biologic Treatment Withdrawal","EXPERIMENTAL","Patients with Takayasu arteritis in sustained clinical and radiologic remission who have received biologic therapy for at least 3 years will undergo a predefined 3-month biologic dose tapering protocol followed by complete treatment discontinuation and a 12-month follow-up period to evaluate remission maintenance and relapse rates.",[13,14,15,16],"Drug: Tociliuzumab","Drug: Infliximab","Drug: Adalimumab","Drug: Certolizumab Pegol",[18,24,28,32],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":23},"DRUG","Tociliuzumab","Dose tapering of tocilizumab followed by complete treatment discontinuation after a 3-month tapering period in patients with Takayasu arteritis in sustained clinical and radiologic remission.",[9],null,{"type":19,"name":25,"description":26,"armGroupLabels":27,"otherNames":23},"Infliximab","Dose tapering of infliximab followed by treatment discontinuation after a predefined 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.",[9],{"type":19,"name":29,"description":30,"armGroupLabels":31,"otherNames":23},"Adalimumab","Dose tapering of adalimumab followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.",[9],{"type":19,"name":33,"description":34,"armGroupLabels":35,"otherNames":23},"Certolizumab Pegol","Dose tapering of certolizumab pegol followed by treatment discontinuation after a 3-month tapering protocol in patients with Takayasu arteritis in sustained remission.",[9],[37],{"name":38,"affiliation":5,"role":39},"Fatma Alibaz-Oner, MD","PRINCIPAL_INVESTIGATOR",[41],{"name":38,"role":42,"phone":43,"phoneExt":23,"email":44},"CONTACT","05326368554","falibaz@gmail.com",[46],{"facility":47,"status":48,"city":49,"state":23,"zip":23,"country":50,"countryCode":23,"cosmosGeoPoint":51,"geoPoint":56,"contacts":57},"Marmara University Pendik Training and Research Hospital","RECRUITING","Istanbul","Turkey (Türkiye)",{"type":52,"coordinates":53},"Point",[54,55],28.94966,41.01384,{"lat":55,"lon":54},[58],{"name":38,"role":42,"phone":23,"phoneExt":43,"email":44},{"type":39,"investigatorFullName":60,"investigatorTitle":61,"investigatorAffiliation":5,"oldNameTitle":23,"oldOrganization":23},"Fatma Alibaz Oner","Professor of Rheumatology","100630764","biologic-treatment-withdrawal-in-takayasu-arteritis-patients-in-sustained-remission-100630764",false,"NCT07491913","Biologic Treatment Withdrawal in Takayasu Arteritis Patients in Sustained Remission","Cessation of Biologic Treatment in Patients With Takayasu Arteritis in Sustained Remission","Inclusion Criteria:\n\n* Diagnosis of Takayasu arteritis according to the 2022 American College of Rheumatology\u002FEULAR classification criteria\n* Treatment with biologic therapy (TNF inhibitors or tocilizumab) for at least 3 years\n* Sustained clinical, laboratory, and radiologic remission\n* No change in treatment during the previous 12 months\n* No glucocorticoid use within the previous 6 months\n* Ability and willingness to provide written informed consent\n\nExclusion Criteria:\n\n* Presence of other active inflammatory diseases requiring biologic therapy (e.g., inflammatory bowel disease, ankylosing spondylitis)\n* Inability to attend scheduled follow-up visits after treatment tapering and discontinuation\n* Pregnancy or planning pregnancy during the study period","ALL","18 Years",{"count":72,"type":73},40,"ESTIMATED","INTERVENTIONAL",[76],"NA","Takayasu arteritis is a chronic large-vessel vasculitis affecting the aorta and its major branches. Biologic therapies such as tumor necrosis factor inhibitors and tocilizumab are commonly used in patients with refractory or relapsing disease. However, there is limited evidence regarding the optimal duration of biologic therapy and the safety of treatment discontinuation in patients who achieve sustained remission.\n\nThis prospective study aims to evaluate the outcomes of planned biologic treatment withdrawal in patients with Takayasu arteritis who have been in long-standing clinical and radiologic remission and have received biologic therapy for at least three years. Eligible patients will undergo a predefined 3-month dose tapering protocol. Patients who remain relapse-free during this period will discontinue biologic therapy and will be followed for 12 months.\n\nThe primary objective of the study is to determine the proportion of patients who maintain remission after biologic treatment withdrawal. Secondary objectives include evaluating the rate and timing of disease relapse during the tapering phase and the post-withdrawal follow-up period.",[79],"Takayasu Arteritis",[81,82,83,84,85,86],"Takayasu arteritis","Biologic therapy withdrawal","Treatment discontinuation","TNF inhibitors","Tocilizumab","Large vessel vasculitis","2026-03-18",{"date":89,"type":90},"2026-03-25","ACTUAL",{"date":92,"type":90},"2025-06-15",{"date":94,"type":73},"2027-12-15",{"name":5,"class":6},1]