Safety and Efficacy Study of Prefilled Liquid Etanercept(Yisaipu) for Active Ankylosing Spondylitis

Summary

This randomized, double-blind, phase III parallel-group non-inferiority study aimed to investigate the efficacy and safety of prefilled liquid etanercept (Yisaipu) versus lyophilized etanercept powder (Yisaipu) in active ankylosing spondylitis patients.

Timeline

Start

2014-03-06

Primary completion

2015-07-13

Completion

2015-07-20

Publications

• Zhao D, He D, Bi L, Wu H, Liu Y, Wu Z, Li Y, Wang G, Li X, Bao C, Jiang L, Zhang Z, Xiao W, Tong G, Wang D, Huang F. Safety and Efficacy of Prefilled Liquid Etanercept-Biosimilar Yisaipu for Active Ankylosing Spondylitis: A Multi-Center Phase III Trial. Rheumatol Ther. 2021 Mar;8(1):361-374. doi: 10.1007/s40744-021-00276-1. Epub 2021 Feb 9.

Drugs

Indications