Study of Wangbi Granules with Methotrexate and Tofacitinib for Rheumatoid Arthritis Post-Marketing Re-evaluation to Improve Treatment and Remission

What this Trial Is About

Researchers are evaluating the use of Wangbi granules in patients with rheumatoid arthritis who have low disease activity after receiving standard treatments of methotrexate and tofacitinib citrate. This phase 4 randomized controlled trial aims to observe the degree of clinical remission and provide evidence to improve treatment outcomes by combining traditional Chinese medicine with Western medicine. The study is sponsored by China-Japan Friendship Hospital and focuses on enhancing remission depth and care quality for rheumatoid arthritis. Participants are randomly assigned to one of two groups one receiving methotrexate and tofacitinib plus Wangbi granules, and the other receiving methotrexate and tofacitinib plus a Wangbi granules simulant. Both groups take their assigned treatments three times daily for a treatment course of three months. The study uses a triple-blind design to assess the effects of the combination therapies over the treatment period. During the study, participants will be monitored over 12 weeks, with evaluations including the Disease Activity Score 28 DAS28, Fatigue Scale-14, and a visual analogue scale to measure symptoms and treatment response. Researchers will assess clinical remission, fatigue levels, and pain or discomfort. Safety and adherence will be tracked, and participants are followed through the studys duration, which ends in March 2026.

Post-marketing Re-evaluation of WangBi Granules for Rheumatoid Arthritis