Comparison of Tofacitinib and Prednisolone in the Treatment of Active Takayasu's Arteritis (TOFGCTAK)
Takayasu Arteritis
About this trial
This is an interventional treatment trial for Takayasu Arteritis focused on measuring Tofacitinib, prednisolone
Eligibility Criteria
Inclusion Criteria: Patients aged between 18-65 years old; Fulfilled the classification criteria of Takayasu's arteritis by ACR 1990; Active TAK: defined by the definition of active disease in the recommendations released by EULAR in 2018 or Kerr's criteria by NIH; Patients who signed the informed consent form. Exclusion Criteria: Patients who failed or intolerant to either tofacitinib or its similar drugs; Patients with severe liver disease defined by the serum ALT or AST elevated more than 2 times the upper limits; Not well controlled diabetes; Moderate and severe hyperlipedimia; Patients with history of thrombus; Uncontrolled heart failure od renal dysfunction (eGFR <30ml/min); Patients with active infection, including tuberculosis, hepatitis B and C, HIV infection, bacterial or fungal infection; Upper GI bleeding happened in 3 months before enrollment; Refractory hypertension; Pregnant or intended to be pregnant recently; Severe coronary artery involvement demonstrated by CTA; Severe cranial or cervical or renal artery diseases that need surgery; Patients that should not be included judged by the investigator.
Sites / Locations
- Peking Union Medical College HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Tofacitinib group
Prednisolone group
Tofacitinib 5mg BID taken orally for 24 weeks and placebo of prednisolone taken daily according to preset tapering protocol during same period
Prednisolone taken daily according to preset tapering protocol and placebo of tofacitinib 5mg BID taken orally for 24 weeks