Treatment of Axial Spondyloarthritis by Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc Fusion Protein
Status:
Completed
Trial end date:
2016-08-28
Target enrollment:
Participant gender:
Summary
This is a randomized, double-blind, multicentral clinical trial to investigate the efficacy
and safety of Recombinant Human Tumor Necrosis Factor-α Receptor Ⅱ IgG Fc fusion protein
injection (Yisaipu®) in the treatment of active axial spondyloarthritis(SpA). The primary
purpose is to assess the different situations in maintaining treatment programme in SpA
patients with controlled inflammation by Yisaipu®. And the second purpose is to assess the
eficacy and safety of Yisaipu® in axial SpAs. The trial will include 150 patients with stable
NSAIDs therapy, and at the first stage they will receive 24-week full-dose of Yisaipu®. Then
at the second stage the patients who achieve low disease activity (LDA, ASDAS<2.1) at 24th
week will be randomizedly divided into three group: full-dose of Yisaipu® group, half-dose of
Yisaipu® group and placebo group. And the blind stage will last for 48 weeks. Patients who
complete the 72-week therapy or achieve disease-flare criteria during the blind stage would
finish the study.