This is a prospective, double-blinded, single center, randomized clinical trial. It compares the clinical efficacy and safety of thees 2 drugs in the treatment of active Takayasu's arteritis patients.
In this study, 40 Takayasu's arteritis patients with active disease will be enrolled. Patients are randomized into the tofacitinib treatment group and prednisolone treatment group. Patients will follow the same reduction steps for prednisolone and its placebo. The primary end point is the percentage of patients who are in complete response at week 24. The efficacy will be evaluated at week 4, 12 and 24. Safety is also monitored during the study.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
Tofacitinib 5 MG BID taken orally for 24 weeks
Prednisolone taken daily according to preset tapering protocol
Placebo of tofacitinib 5mg BID taken orally for 24 weeks
Peking Union Medical College Hospital
Beijing, China
RECRUITINGPercentage of patients with complete response
Percentage of patients with complete response at week 24
Time frame: week 24
Percentage of patients with partial response
Percentage of patients with partial response at week 24
Time frame: week 24
Percentage of patients with adverse events due to treatment of tofacitinib
Percentage of patients with adverse events due to treatment of tofacitinib at week 24
Time frame: 24 weeks
Percentage of patients with adverse events due to treatment of prednisolone
Percentage of patients with adverse events due to treatment of prednisolone at week 24
Time frame: 24 weeks
Percentage of patients with progression, no change, and improvement in vessel image at the end of study
Percentage of patients with progress disease, stable disease, and improved disease demonstrated by CTA, MRI or Doppler at week 24
Time frame: week 24
Intervention procedures
Percentage of patients who require intervention procedures during the study period
Time frame: 24 weeks
Complication of Takayasu's arteritis
Complication of Takayasu's arteritis happened during 24 weeks
Time frame: 24 weeks
Glucocorticoid toxicity index
Glucocorticoid toxicity index at week 24 which indicate the toxicity of prednisolone.
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Placebo of prednisolone taken daily according to preset tapering protocol for 24 weeks
Time frame: week 24