Accepted for/Published in: JMIR Research Protocols
Date Submitted: Nov 6, 2025
Date Accepted: Mar 27, 2026
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Best evidence for tripterygium glycoside tablets (TGTs) combined with csDMARDs for treating rheumatoid arthritis：study protocol for a prospective, multicenter, open-label, randomized controlled trial
ABSTRACT
Background:
Tripterygium glycoside tablets (TGTs), a csDMARD based on traditional Chinese medicines, have shown promise as a cost-effective alternative for rheumatoid arthritis (RA), but there is limited evidence on the optimal combination with other csDMARDs (methotrexate [MTX], leflunomide [LEF], hydroxychloroquine [HCQ]). This study evaluates the 12-week efficacy and safety of TGTs-based regimens in RA patients with moderate disease activity (DAS28 3.2-5.1).
Objective:
The clinical efficacy and safety of the csDMARDs combination regimen mainly based on Tripterygium glycosides tablets in the treatment of rheumatoid arthritis (RA) were evaluated using multi-center clinical data. and explore the clinical characteristics of Tripterygium wilfordii and the optimal combination therapy based on randomized controlled trials.
Methods:
This multicenter, open-label, randomized controlled trial (RCT) recruited 188 participants (47 per group) from 3 Chinese hospitals. Eligible patients (age 18-65 years, DAS28 3.2-5.1, no planned childbearing) were stratified by study center and randomized 1:1:1:1:1 to TGTs monotherapy, TGTs+MTX, TGTs+LEF or TGTs+HCQ. The primary endpoints were ACR20 remission rate and DAS28 remission rate; secondary endpoints included clinical disease activity index (CDAI), simplified disease activity index (SDAI), pain VAS (0 ~ 10 points). Patient General Assessment (PGA) and Medical Doctor General Assessment (MDGA). Quality of Life (SF-36), Health Assessment Questionnaire-Disability Index (HAQ-DI). All enrolled patients will be followed up every 4 weeks for a total of 12 weeks. Adverse events will be recorded during the observation period of the study. All patients randomized in this study will be included in the intention-to-treat analysis.
Results:
Recruitment for this study began on September 1, 2024, and is scheduled to end on December 31, 2025. To date, 102 participants have been enrolled, among whom 35 have completed the intervention and post-treatment assessment (TGTs monotherapy: n=16, TGTs+MTX: n=15, TGTs+LEF: n=15, TGTs+HCQ: n=13). After the plan is announced, data compilation and analysis will be carried out. It is expected that the results will be published in relevant journals in 2026.
Conclusions:
This pilot trial utilized multi-center clinical data to evaluate the clinical efficacy and safety of the csDMARDs combination regimen mainly based on Tripterygium wilfordii Tablets in the treatment of rheumatoid arthritis (RA), explore the clinical characteristics of Tripterygium wilfordii Tablets and the optimal combination therapy, and provide evidence-based medical evidence for the risk-benefit ratio of combination therapy with Tripterygium wilfordii tablets in the treatment of RA. Clinical Trial: Chinese Clinical Trial Registry ChiCTR2400088173
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