Evaluating the Safety and Effectiveness of Tofacitinib Compared to Methotrexate with Prednisone in Adults with Active Takayasus Arteritis

What this Trial Is About

This research aims to compare the effectiveness and safety of two treatments, tofacitinib and methotrexate, in patients with Takayasus arteritis, a chronic inflammation of large blood vessels including the aorta and its branches. Current treatments with glucocorticoids and immunosuppressants often do not fully control the disease or prevent relapses, so this study seeks to find better options. The trial is a randomized controlled study sponsored by Shanghai Zhongshan Hospital focusing on active phase patients aged 18 to 65 years. Participants will be randomly assigned to receive either tofacitinib tablets 5 mg twice daily or methotrexate tablets 15 mg once weekly, both for 12 months. Both groups will also receive prednisone with an initial dose and a tapering schedule based on disease activity. The prednisone dose starts high and is gradually reduced over 12 months if patients meet criteria for inactive disease, following specific tapering steps during the first and second half of the year. During the study, participants will be monitored regularly to assess treatment effectiveness, remission rates, relapse-free survival, glucocorticoid dosage, and side effects over 12 months. The primary outcome is the effectiveness rate after 6 months of treatment. Safety and other secondary outcomes will also be tracked. The study involves clinical evaluations, laboratory tests, and disease activity assessments to measure how well the treatments work and their safety.

Comparison of Tofacitinib and Methotrexate in Takayasu's Arteritis