[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100385590":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":47,"responsibleParty":65,"collaborators":42,"id":67,"slug":68,"hasResults":69,"nctId":70,"briefTitle":71,"officialTitle":72,"acronym":42,"eligibilityCriteria":73,"healthyVolunteers":69,"sex":74,"minAge":75,"maxAge":76,"enrollmentInfo":77,"targetDuration":42,"studyType":80,"phases":81,"briefSummary":83,"conditions":84,"keywords":87,"overallStatus":50,"whyStopped":42,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Tocilizumab","ACTIVE_COMPARATOR","This group of 20 TAK cases are prescribed with tocilizumab (Dose: 8mg\u002Fkg. qm. ivgtt.) for 24 weeks.",[13],"Biological: Tocilizumab",{"label":15,"type":16,"description":17,"interventionNames":18},"Adalimumab","EXPERIMENTAL","This group of 20 TAK cases are prescribed with adalimumab (Dose: 40mg.bim.IH.) for 24 weeks.",[19],"Biological: Adalimumab",[21,27],{"type":22,"name":9,"description":23,"armGroupLabels":24,"otherNames":25},"BIOLOGICAL","The tocilizumab group is prescribed with tocilizumab (8mg\u002Fkg.qm.ivgtt.) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).\n\nAfter 24 weeks of treatment, if the disease is alleviated (remission), then the usage of tocilizumab is maintained for another 24 weeks, otherwise (resistant), patients would be given adalimumab (40mg.bim.IH.) for 24 weeks instead.",[9],[26],"IL-6R alpha antibody",{"type":22,"name":15,"description":28,"armGroupLabels":29,"otherNames":30},"The adalimumab group is prescribed with adalimumab (40mg.bim.IH) for 24 weeks, and the disease activity is monitored in the follow-up (primary endpoint).\n\nAfter 24 weeks of treatment, if the disease is alleviated (remission), then the usage of adalimumab would be maintained for another 24 weeks, otherwise (resistant), patients would be given tocilizumab (8mg\u002Fkg.qm.ivgtt.) for 24 weeks instead.",[15],[31],"TNF-alpha antibody",[33],{"name":34,"affiliation":35,"role":36},"Lindi Jiang, PhD","Fudan University","STUDY_CHAIR",[38,44],{"name":39,"role":40,"phone":41,"phoneExt":42,"email":43},"Rongyi Chen, PhD","CONTACT","+8615221160538",null,"chenry825@hotmail.com",{"name":45,"role":40,"phone":41,"phoneExt":42,"email":46},"Lili Ma, PhD","zsh-rheum@hotmail.com",[48],{"facility":49,"status":50,"city":51,"state":52,"zip":53,"country":54,"countryCode":55,"cosmosGeoPoint":56,"geoPoint":61,"contacts":62},"Department of Rheumatology in Zhongshan hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":57,"coordinates":58},"Point",[59,60],121.45806,31.22222,{"lat":60,"lon":59},[63],{"name":34,"role":40,"phone":64,"phoneExt":42,"email":46},"+86-021-64041990",{"type":66,"investigatorFullName":42,"investigatorTitle":42,"investigatorAffiliation":42,"oldNameTitle":42,"oldOrganization":42},"SPONSOR","100385590","phase-4-a-pilot-study-in-severe-patients-with-takayasu-arteritis-100385590",false,"NCT04300686","A Pilot Study in Severe Patients With Takayasu Arteritis.","A Pilot Study in the Treatment of Severe Patients With Takayasu Arteritis With Tocilizumab and Adalimumab, Based on ECTA Cohort","Inclusion Criteria:\n\n1. age≥14 years old;\n2. active: Kerr score≥ 2;\n3. severe:\n\n   1. Blood pressure \\> 180\u002F110mmHg;\n   2. ≥ 3 branches with the stenotic rate \\> 70% involved;\n   3. high degree of organ insufficiency: NYHF III\\~IV; eGFR (MRDR) 15\\~ 60ml\u002Fmin;\n\nExclusion Criteria:\n\n1. Severe organ insufficiency;\n2. Acute or chronic active infections including tuberculosis, hepatitis virus, etc.;\n3. Other autoimmune diseases including systemic lupus erythematosus, Behcet disease, IgG4 relative disease;\n4. malignant tumors;\n5. history of severe drug allergy;\n6. successive twice relapse occurs even after the intervention adjustment ( for the benefits of patients)","ALL","14 Years","100 Years",{"count":78,"type":79},40,"ESTIMATED","INTERVENTIONAL",[82],"PHASE4","Takayasu arteritis (TAK) is a rare chronic inflammatory arteritis, which lacks an effective well-accepted intervention strategy. We classify TAK patients into 3 levels, including mild, moderate, and severe. And the biological agents tocilizumab and adalimumab are randomly prescribed in severe patients, to find out the relatively better treatment strategy, facilitating better intervention strategy in severe TAK patients.",[85,9,15,86],"Takayasu Arteritis","Treatment",[85,9,15,88],"treatment","2021-08-07",{"date":91,"type":92},"2021-08-10","ACTUAL",{"date":94,"type":92},"2020-03-01",{"date":96,"type":79},"2023-12-31",{"name":5,"class":6},1]