This is a prospective,open-labelled,multi-center,randomized clinical trial.It compares the clinical efficacy and safety of there 2 drugs in the treatment of relapse active Takayasu's arteritis patients.
In this study, 100 relapse Takayasu's arteritis patients will be enrolled. Patients are randomized into the adalimumab treatment group and tofacitinib treatment.Patients will also be treated with reduced dose of glucocorticoid at the same time. The primary end point is the percentage of patients who are in complete response at week 12 and maintain in complete response at week 78. The efficacy will be evaluated at week 12, 24, 36, 52 and 78. If the patient does not respond to one drug at week 24, then the investigator will shift the treatment to another intervention. Safety is also monitored during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
100
Adalimumab Injection injected subcutaneously every other week for 78 weeks
Tofacitinib 5 MG BID taken orally for 78 weeks
Beijing Anzhen Hospital
Beijing, China
RECRUITINGThe General Hospital of the People's Liberation Army
Beijing, China
NOT_YET_RECRUITINGBeijing Shijitan Hospital
Beijing, China
NOT_YET_RECRUITINGpercentage of patients with complete response
percentage of patients with complete response at week 78
Time frame: week 78
percentage of patients with partial response
percentage of patients with partial response at week 78
Time frame: week 78
Percentage of patients with image progression at the end of study
percentage of patients with progress disease demonstrated by CTA or Doppler at week 78
Time frame: week 78
adverse events
safety profile of both Adalimumab and Tofacitinib treatment group
Time frame: 78 weeks
intervention procedures
percentage of patients who require intervention procedures during the study period
Time frame: 78 weeks
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Beijing Xuanwu Hospital
Beijing, China
NOT_YET_RECRUITING