Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)

Summary

This two-part study was to evaluate the effect of golimumab (SCH 900259, MK-8259) in participants with active axial spondyloarthritis (axial SpA). In Part 1, participants were to receive golimumab 50 mg or matching placebo subcutaneous injections on Day 1 (Baseline) and at Weeks 4, 8, and 12. During Part 1 of the study, participants were to not know the identity of the injection. In the Part 2 extension, all participants were to receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then every 4 weeks up to Week 48. In Part 2, the participants were to be told they were receiving active study drug. The primary hypothesis of this study was that treatment with golimumab 50 mg every 4 weeks is superior to placebo as measured by the proportion of participants achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 response at Week 16.

Timeline

Start

2012-02-13

Primary completion

2014-03-11

Completion

2015-01-15

Publications

• Results Sieper J, van der Heijde D, Dougados M, Maksymowych WP, Scott BB, Boice JA, Berd Y, Bergman G, Curtis S, Tzontcheva A, Huyck S, Weng HH. A randomized, double-blind, placebo-controlled, sixteen-week study of subcutaneous golimumab in patients with active nonradiographic axial spondyloarthritis. Arthritis Rheumatol. 2015 Oct;67(10):2702-12. doi: 10.1002/art.39257.
• van der Heijde D, Dougados M, Maksymowych WP, Bergman G, Curtis SP, Tzontcheva A, Huyck S, Philip G, Sieper J. Long-term tolerability and efficacy of golimumab in active non-radiographic axial spondyloarthritis: results from open-label extension. Rheumatology (Oxford). 2022 Feb 2;61(2):617-627. doi: 10.1093/rheumatology/keab346.

Drugs

Indications