Effectiveness and Safety of Yisaipu Combined With Tripterygium Wilfordii for Active RA

Phase 4 Completed 504 enrolled Peking Union Medical College Hospital

RandomizedParallel-groupQuadruple-blindTreatment

Summary

In this 24-week, multi-center, randomized, double-blind study, the investigators will evaluate the efficacy and safety profile of subcutaneously injected Yisaipu, a Tumor Necrosis Factor Receptor Fusion Protein, combined with oral Tripterygium Wilfordii for patients with active rheumatoid arthritis.

Timeline

Start: 2019-05-14
Primary completion: 2022-03-20
Completion: 2022-07-27

Outcome

Met primary endpoint

paper ACR50 was achieved in 57.1% (72/126), 41.3% (52/126), 23.0% (29/126), and 26.2% (33/126) patients PMID 37657525 ↗

paper TwHF+rhTNFR-Fc vs. other three groups, all p < 0.05 PMID 37657525 ↗

paper TwHF+rhTNFR-Fc was superior to MTX for active RA, and was more effective than MTX + rhTNFR-Fc on ACR50 PMID 37657525 ↗

Publications

Zhang X, Yang H, Zuo X, Wu L, Peng J, Li Z, Li H, Ji W, Zhang L, Li X, Dai L, Lu L, Yang N, Wei W, Shuai Z, Jiang Y, Liu Y, Lipsky PE, Chen H; YISTAR study group. Efficacy and safety of tripterygium wilfordii Hook F plus TNF inhibitor for active rheumatoid arthritis: A multicentre, randomized, double-blind, triple-dummy controlled trial. Clin Immunol. 2023 Oct;255:109749. doi: 10.1016/j.clim.2023.109749. Epub 2023 Aug 30.

Drugs

Evaluation	Drug	Modality	Dose	Route
Comparator	Methotrexate	Small molecule	15 mg	Oral
Subject	YISAIPU	Protein / enzyme biologic	50 mg	Subcutaneous
Subject	tripterygium wilfordii	Traditional medicine (herbal / TCM)	20 mg	Oral