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Tripterygium Glycoside Tablets Combined With Conventional Synthetic Disease-Modifying Antirheumatic Drugs for
Liu Lv1, Tuoran Wang2, Jing Lv3
1Department of Rheumatology, Dongzhimen Hospital Affiliated to Beijing University of Chinese Medicine, Beijing, China.
JMIR Research Protocols
|April 27, 2026
Summary
Tripterygium glycoside tablets (TGTs) show promise for rheumatoid arthritis (RA). This study evaluated TGT combinations with other disease-modifying antirheumatic drugs (csDMARDs), providing evidence for optimal RA treatment strategies.
Area of Science:
- Rheumatology
- Pharmacology
- Traditional Chinese Medicine
Background:
- Tripterygium glycoside tablets (TGTs), a traditional Chinese medicine, are a cost-effective option for rheumatoid arthritis (RA).
- Limited evidence exists on optimal combinations of TGTs with conventional synthetic disease-modifying antirheumatic drugs (csDMARDs) like methotrexate, leflunomide, and hydroxychloroquine.
- This study focuses on moderately active RA patients.
Purpose of the Study:
- To evaluate the clinical efficacy and safety of TGT-based combination regimens for RA treatment.
- To explore clinical characteristics of TGTs.
- To identify optimal combination therapy through a randomized controlled trial (RCT) using multicenter data.
Main Methods:
- A multicenter, open-label RCT involving 188 participants (47 per group) from 3 hospitals.
- Patients were randomized to TGT monotherapy, TGT plus methotrexate, TGT plus leflunomide, or TGT plus hydroxychloroquine.
- Primary outcome: American College of Rheumatology 20% improvement response rate; secondary outcomes included DAS28, CDAI, SDAI, pain VAS, global assessments, quality of life, and HAQ-DI over 12 weeks.
Main Results:
- Participant recruitment occurred from September 2024 to December 2025, with 181 patients enrolled.
- Data collection is complete; data cleaning is in progress.
- Statistical analyses are pending; primary results are expected by the end of 2026.
Conclusions:
- The trial utilizes multicenter clinical data to offer robust evidence on TGT combinations for moderately active RA.
- Findings will inform the efficacy and safety of TGT-based regimens in RA management.
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