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.
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Presence of organ failure;
undergoing haemodialysis or major surgery (grade III and above) within 3 months;
the presence of other autoimmune diseases;
severe, progressive organ damage;
Parallel
Prednisone
DrugThis 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/day), and then tapered gradually during the study course.
Methotrexate
DrugThis drug will be used in the traditional arm. A dose of 15mg per week will be used.
Tocilizumab
DrugThis drug will be used in the precise treatment arm. For patients in constitutional type a dose (8mg/kg weight) will be used every 2 weeks (iv drip) for 12 weeks, then a dose (8mg/kg weight) will be used every 4 weeks (iv drip). For patients in vascular inflammation type, a dose (8mg/kg weight) will be used every 4 weeks (iv drip).
Tofacitinib
DrugThis drug will be used in the precise treatment arm. A sustained release tablet will be used (11mg per day).
Adalimumab
DrugThis drug will be used in the precise treatment arm. A dose of 40mg (ih) will used every 2 weeks.
Effectiveness rate
Effectiveness is defined if patients meet the following three in criteria ①-④ and criteria ⑤. * No systemic symptoms such as fever, malaise, or wasting; * No new onset of vascular symptoms and signs; * Normal blood sedimentation (in case of abnormality, it is necessary to exclude non-disease active factors and to review and evaluate with the review value); ④ Imaging: no progression of primary vascular lesions or new vascular lesions; ⑤ Glucocorticoids are reduced to 7.5mg/day and maintained for at least 4 weeks.
Effectiveness rate
* No systemic symptoms such as fever, malaise, or wasting; * No new onset of vascular symptoms and signs; * Normal blood sedimentation (in case of abnormality, it is necessary to exclude non-disease active factors and to review and evaluate with the review value); ④ Imaging: no progression of primary vascular lesions or new vascular lesions; ⑤ Glucocorticoids are reduced to 5mg/day and maintained for at least 4 weeks.
Relapse rate
The relapse is defined as disease re-activation after remission. Disease activity is assessed according to NIH criteria. NIH≥2 is considered active status. NIH criteria includes: * Systemic symptoms, such as fever, skeletal and muscular symptoms; * Blood sedimentation (erythrocyte sedimentation rate, ESR) \>20mm/H; ③ Characteristics of vascular ischaemia or inflammation: e.g. intermittent claudication, diminished or absent pulse, vascular murmur, vascular pain blood pressure asymmetry; ④Abnormalities of angiography.
Time to the first relapse
The first time to develop relapse during 12 months' treatment.
Adverse events
The occurrence of adverse events and the corresponding rate.
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