[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100513236":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":33,"centralContacts":38,"locations":48,"responsibleParty":65,"collaborators":67,"id":69,"slug":70,"hasResults":71,"nctId":72,"briefTitle":73,"officialTitle":74,"acronym":32,"eligibilityCriteria":75,"healthyVolunteers":71,"sex":76,"minAge":77,"maxAge":78,"enrollmentInfo":79,"targetDuration":32,"studyType":82,"phases":83,"briefSummary":85,"conditions":86,"keywords":88,"overallStatus":51,"whyStopped":32,"lastUpdateSubmitDate":91,"lastUpdatePostDateStruct":92,"startDateStruct":95,"completionDateStruct":97,"leadSponsor":99,"locationsCount":100},{"fullName":5,"class":6},"Chinese SLE Treatment And Research Group","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Placebo arm","PLACEBO_COMPARATOR","Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the placebo of Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)",[13],"Other: Placebo of Telitacicept",{"label":15,"type":16,"description":17,"interventionNames":18},"Telitacicept treatment arm","EXPERIMENTAL","Patients with active AAV will be treated with Rituximab and glucocorticoid to induce remission. And the Telitacicept would be given 80 mg every week subcutaneously for 12 months. Glucocorticoid would be tapered as recommended by 2022 EULAR AAV recommendation (as protocol of PEXIVAS study)",[19],"Drug: Telitacicept",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","Telitacicept","Patient will be treated with Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months",[15],[27],"Taiai for commercial name",{"type":6,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo of Telitacicept","Patient will be treated with placebo of Telitacicept (Taiai the commercial name) 80 mg every week subcutaneously for 12 months",[9],null,[34],{"name":35,"affiliation":36,"role":37},"Jing Li, MD","Peking Unione Mdecial College Hospital","PRINCIPAL_INVESTIGATOR",[39,44],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},"Yunjiao Yang, MD","CONTACT","86-13671313079","yangyunjiao81@163.com",{"name":45,"role":41,"phone":46,"phoneExt":32,"email":47},"Hanqi Wang, RN","86-15810927696","lijing6515@pumch.cn",[49],{"facility":50,"status":51,"city":52,"state":32,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Peking Union Medical College Hospital","RECRUITING","Beijing","100730","China","CN",{"type":57,"coordinates":58},"Point",[59,60],116.39723,39.9075,{"lat":60,"lon":59},[63,64],{"name":40,"role":41,"phone":42,"phoneExt":32,"email":43},{"name":45,"role":41,"phone":46,"phoneExt":32,"email":47},{"type":66,"investigatorFullName":32,"investigatorTitle":32,"investigatorAffiliation":32,"oldNameTitle":32,"oldOrganization":32},"SPONSOR",[68],{"name":50,"class":6},"100513236","phase-4-efficacy-and-safety-for-rituximab-combined-with-telitacicept-in-the-treatment-of-anca-associated-vasculitis-ttcaavrem-100513236",false,"NCT05962840","Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis (TTCAAVREM)","A Prospective, Randomized, Single-blinded Placebo-controlled, Single Center Clinical Study of the Efficacy and Safety for Rituximab Combined With Telitacicept in the Treatment of ANCA-associated Vasculitis","Inclusion Criteria:\n\n1. Patients age 18 to 65 years, both genders can be included.\n2. Patients who are newly diagnosed or relapsing granulomatosis with polyangiitis or microscopic polyangiitis must fulfill the 2022 ACR\u002FEULAR classification criteria of GPA or MPA.\n3. Patients have severe active AAV according to the 2021 ACR\u002Fvasculitis foundation definition.\n4. Patients have to be PR3-ANCA-positive at diagnosis or during the course of their disease.\n\nExclusion Criteria:\n\n1. Patients who had been treated with Rituximab but had to stop due to adverse events or intolerance.\n2. Patients who had other autoimmune diseases.\n3. Patients with severe liver dysfunction (defined as the 2-folds elevation of normal upper limit or Child grade III), heart failure or ESRD (eGFR\\\u003C30ml\u002Fmin).\n4. Patients who are pregnant or have planned for pregnancy in next 2 years.\n5. Patients with uncontrolled sever hypertension, diabetes, active bacteria or fungal infection.\n6. Patients with active hepatitis virus infection as well as patients who have active mycobacteria infection.\n7. Patients with malignancy.\n8. Patients who are not eligible according to the judge of the principal investigators.","ALL","18 Years","65 Years",{"count":80,"type":81},40,"ESTIMATED","INTERVENTIONAL",[84],"PHASE4","This study is a prospective, open-labelled, randomized, controlled, single-center clinical trial. The aim of this study is to investigate the remission rate of patients treated with Telitacicept combined with Rituximab in remission-induction and Telitacicept alone in remission-maintain treatment.",[87],"ANCA Associated Vasculitis",[23,89,90],"relapse rate","remission maintain treatment","2023-07-19",{"date":93,"type":94},"2023-07-27","ACTUAL",{"date":96,"type":94},"2023-06-29",{"date":98,"type":81},"2026-12-31",{"name":5,"class":6},1]