Efficacy and Safety of IBI303 in Adult Patients With Active Ankylosing Spondylitis

Summary

Study of the efficacy and safety of IBI303 compared with adalimumab in adult patients with ankylosing spondylitis (AS) who have had an inadequate response to or who are intolerant to one or more nonsteroidal anti-inflammatory drugs (NSAIDs)

Timeline

Start

2016-09-22

Primary completion

2018-01-22

Completion

2018-03-16

Publications

• Results Huang F, Gu J, Zhu P, Bao C, Xu J, Xu H, Wu H, Wang G, Shi Q, Andhivarothai N, Anderson J, Pangan AL. Efficacy and safety of adalimumab in Chinese adults with active ankylosing spondylitis: results of a randomised, controlled trial. Ann Rheum Dis. 2014 Mar;73(3):587-94. doi: 10.1136/annrheumdis-2012-202533. Epub 2013 Mar 8.
• Xu H, Li Z, Wu J, Xing Q, Shi G, Li J, Liu X, Wu L, Li X, Tan W, He D, Bi L, Li H, Xiao Z, Shuai Z, Li X, Wang Y, Luo L, Zheng Y, Xiao W, Wu X, Zhou L, Li T, Qian L, Zhou H, Lu S, Zheng S, Xiong Y, Wang X, Wang Y, Wu X. IBI303, a biosimilar to adalimumab, for the treatment of patients with ankylosing spondylitis in China: a randomised, double-blind, phase 3 equivalence trial. Lancet Rheumatol. 2019 Sep;1(1):e35-e43. doi: 10.1016/S2665-9913(19)30013-X. Epub 2019 Aug 28.

Drugs

Indications

No indication recorded.