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

Sponsor
Merck Sharp & Dohme LLC
Study ID
NCT01453725
Phase
PHASE3
Status
Completed

Conditions

  • Spondylitis, Ankylosing

Eligibility Criteria

Sex
ALL
Age
18 Years - 45 Years
Healthy Volunteers
Not accepted

Interventions

  • Golimumab — BIOLOGICAL
    Golimumab 50 mg SC injection every 4 weeks
  • Placebo — BIOLOGICAL
    Placebo SC injection every 4 weeks

Study Details

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.

Key Dates

Start date
Feb 13, 2012
Status verified
Jan 2019
Primary completion
Mar 11, 2014
Completion
Jan 15, 2015

Study Design

Enrollment
198 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Golimumab→Golimumab
    In Part 1, participants receive golimumab 50 mg, administered subcutaneously (SC) every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 48 weeks treatment with golimumab.)
  • Placebo Comparator: Placebo→Golimumab
    In Part 1, participants receive placebo, administered SC every 4 weeks for up to 12 weeks (16 weeks of treatment). In Part 2, participants receive golimumab 50 mg, administered SC every 4 weeks for up to 28 weeks (32 weeks of treatment). (Combined total of up to 32 weeks treatment with golimumab.)

Primary Outcome Measure

Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16 [ Time Frame: Week 16 ]

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