[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100554361":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":55,"centralContacts":60,"locations":67,"responsibleParty":85,"collaborators":65,"id":87,"slug":88,"hasResults":89,"nctId":90,"briefTitle":91,"officialTitle":91,"acronym":65,"eligibilityCriteria":92,"healthyVolunteers":89,"sex":93,"minAge":94,"maxAge":95,"enrollmentInfo":96,"targetDuration":65,"studyType":99,"phases":100,"briefSummary":102,"conditions":103,"keywords":105,"overallStatus":70,"whyStopped":65,"lastUpdateSubmitDate":108,"lastUpdatePostDateStruct":109,"startDateStruct":112,"completionDateStruct":114,"leadSponsor":116,"locationsCount":117},{"fullName":5,"class":6},"Shanghai Zhongshan Hospital","OTHER",[8,18],{"label":9,"type":10,"description":11,"interventionNames":12},"The precise therapy arm","EXPERIMENTAL","Patients will be given treatment based on their clinical-molecular phenotype according to a predesigned scheme:\n\n1. Patients in constitutional type will be given treatments with GCs combined with TCZ and MTX.\n2. Patients in vascular inflammation type without IL-6 and TNF-α elevation will be given treatments with GCs combined with TOF.\n3. Patients in vascular inflammation type with IL-6 elevation will be given treatments with GCs combined with TCZ and MTX.\n4. Patients in vascular inflammation type with TNF-α elevation will be given treatments with GCs combined with ADA and MTX.",[13,14,15,16,17],"Drug: Prednisone","Drug: Methotrexate","Drug: Tocilizumab","Drug: Tofacitinib","Drug: Adalimumab",{"label":19,"type":20,"description":21,"interventionNames":22},"The traditional therapy arm","ACTIVE_COMPARATOR","Patients will be given traditional treatment based on their clinical-molecular phenotype according to a predesigned scheme.",[13,14],[24,31,37,43,49],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DRUG","Prednisone","This drug will be used in both arms. Patients' initial daily prednisone dose will be calculated according to their weights (0.6mg \\* weight(kg), maximum 50mg\u002Fday), and then tapered gradually during the study course.",[9,19],[30],"Glucocorticoids",{"type":25,"name":32,"description":33,"armGroupLabels":34,"otherNames":35},"Methotrexate","This drug will be used in the traditional arm. A dose of 15mg per week will be used.",[9,19],[36],"MTX",{"type":25,"name":38,"description":39,"armGroupLabels":40,"otherNames":41},"Tocilizumab","This drug will be used in the precise treatment arm. For patients in constitutional type a dose (8mg\u002Fkg weight) will be used every 2 weeks (iv drip) for 12 weeks, then a dose (8mg\u002Fkg weight) will be used every 4 weeks (iv drip). For patients in vascular inflammation type, a dose (8mg\u002Fkg weight) will be used every 4 weeks (iv drip).",[9],[42],"TCZ",{"type":25,"name":44,"description":45,"armGroupLabels":46,"otherNames":47},"Tofacitinib","This drug will be used in the precise treatment arm. A sustained release tablet will be used (11mg per day).",[9],[48],"TOF",{"type":25,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"Adalimumab","This drug will be used in the precise treatment arm. A dose of 40mg (ih) will used every 2 weeks.",[9],[54],"ADA",[56],{"name":57,"affiliation":58,"role":59},"Lindi Jiang, PhD","Fudan University","STUDY_CHAIR",[61],{"name":62,"role":63,"phone":64,"phoneExt":65,"email":66},"Xiufang Kong, PhD","CONTACT","+8618317070593",null,"kongxiufang2007@163.com",[68],{"facility":69,"status":70,"city":71,"state":72,"zip":73,"country":74,"countryCode":75,"cosmosGeoPoint":76,"geoPoint":81,"contacts":82},"Zhongshan Hospital, Fudan University","RECRUITING","Shanghai","Shanghai Municipality","200032","China","CN",{"type":77,"coordinates":78},"Point",[79,80],121.45806,31.22222,{"lat":80,"lon":79},[83],{"name":84,"role":63,"phone":64,"phoneExt":65,"email":66},"Xiufang Kong, PhD.",{"type":86,"investigatorFullName":65,"investigatorTitle":65,"investigatorAffiliation":65,"oldNameTitle":65,"oldOrganization":65},"SPONSOR","100554361","phase-4-a-randomized-controlled-open-label-multicenter-clinical-trial-comparing-the-efficacy-and-safety-of-a-precision-treatment-regimen-based-on-clinical-molecular-phenotypes-with-a-conventional-treatment-regimen-in-the-treatment-of-patients-with-active-takayasus-arteritis-100554361",false,"NCT06498089","A Randomized, Controlled, Open-label, Multicenter Clinical Trial Comparing the Efficacy and Safety of a Precision Treatment Regimen Based on Clinical-molecular Phenotypes with a Conventional Treatment Regimen in the Treatment of Patients with Active Takayasu's Arteritis","Inclusion Criteria:\n\n1\\) Meet the 2022 ACR\u002FEULAR classification criteria for aortitis; 2) Women or men aged 18-65 years; 4) Be in active disease: a National Institutes of Health (NIH) score of ≥2; 5) Females with negative serum or urine pregnancy test results and no plans to have children during the clinical trial; (6) If the patient is taking prednisone or its equivalent, the pre-enrolment dose does not exceed 0.6 mg\u002Fkg\u002Fday and the dose has been stable for at least 4 weeks; 7) If the patient is receiving other medications for aortitis that are inconsistent with the assigned regimen, discontinuation is required for ≥4 weeks for methotrexate, azathioprine, mycophenolate mofetil, cyclosporine, and tacrolimus; for leflunomide, discontinuation is required for 11 days if elimination methods are used (kolexanil or activated charcoal), or ≥8 weeks if elimination is not used; for cyclophosphamide, discontinuation is required for ≥6 months; for biologics, stopping for ≥ 3 weeks is required for etanercept, ≥ 4 weeks for IL-6 receptor antagonists and tumour necrosis factor inhibitors, and ≥ 6 months for rituximab.\n\n8)For patients with no obvious active tuberculosis lesions but elevated T-spot, it is recommended that infectious specialists evaluate them, and preventive anti-tuberculosis therapy should be performed first if necessary. After T-spot declines, researchers will assess the relevant risks before deciding whether they are suitable to participate in this study, and continue preventive anti-tuberculosis therapy for a total of 9 months.\n\n9)For patients with HBV, if the viral replication was detected, it is recommended to take anti-viral treatment for 2-4 weeks, and researchers will evaluate whether they are suitable to participate in this study when no DNA replication is detected.\n\nExclusion Criteria:\n\n1. Presence of organ failure;\n2. undergoing haemodialysis or major surgery (grade III and above) within 3 months;\n3. the presence of other autoimmune diseases;\n4. severe, progressive organ damage;\n5. Subjects with other comorbidities that may result in the need for additional moderate to high doses of glucocorticoids (prednisone ≥ 10 mg\u002Fday or equivalent doses of prednisone equivalents) during the study period;\n6. Have a history of malignancy;\n7. Have any serious acute or chronic infection, including hepatitis B surface antigen positive, active tuberculosis.","ALL","18 Years","65 Years",{"count":97,"type":98},124,"ESTIMATED","INTERVENTIONAL",[101],"PHASE4","This study aimed to compare the efficacy and safety of a precision treatment regimen based on clinical-molecular phenotypes with a conventional treatment regimen in the treatment of patients with active Takayasu's arteritis based on a randomized, controlled, open-label, multicenter study.",[104],"Takayasu Arteritis",[106,107],"Precise treatment","Clinical-molecular phenotype","2024-10-15",{"date":110,"type":111},"2024-10-17","ACTUAL",{"date":113,"type":111},"2024-06-28",{"date":115,"type":98},"2027-06-30",{"name":5,"class":6},1]