NCT01453725

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

A Multicenter, Randomized, Double-blind, Placebo-controlled Study of the Effect of Golimumab Administered Subcutaneously in Subjects With Active Axial Spondyloarthritis (Protocol No. P07642, Also Known as MK-8259-006-02).

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 198 (actual)
• Sponsor: Merck Sharp & Dohme LLC · Industry
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Spondylitis, Ankylosing

Interventions

Type	Name	Description
BIOLOGICAL	Golimumab	Golimumab 50 mg SC injection every 4 weeks
BIOLOGICAL	Placebo	Placebo SC injection every 4 weeks

Timeline

• Start date: 2012-02-13
• Primary completion: 2014-03-11
• Completion: 2015-01-15
• First posted: 2011-10-18
• Last updated: 2019-02-06
• Results posted: 2014-12-18