Phase 3
N=198
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)
Spondylitis, Ankylosing
Bottom Line
View on ClinicalTrials.gov: NCT01453725 ↗Enrolled (actual)
198
Serious AEs
2.1%
Results posted
Dec 2014
Primary outcome: Primary: Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16 — 71.1; 40.0 Percentage of Participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Golimumab (Biological); Placebo (Biological)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Merck Sharp & Dohme LLC
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16 |
71.1; 40.0 | <0.0001 sig |
| PRIMARY Percentage of Participants Who Experienced at Least One Adverse Event (AE) |
41.2; 47.0; 41.9; 54.2 | — |
| PRIMARY Percentage of Participants Who Discontinued Study Drug Due to an AE |
2.1; 1.0; 1.1; 2.1 | — |
| SECONDARY Percentage of Participants Achieving an Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16 |
56.7; 23.0 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16 |
57.7; 30.0 | <0.0001 sig |
| SECONDARY Percentage of Participants Achieving ASAS Partial Remission at Week 16 |
33.0; 18.0 | 0.0136 sig |
| SECONDARY Change From Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacroiliac (SI) Joints Score at Week 16 |
9.87; 12.66; -5.25; -0.95 | <0.0001 sig |
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.
Eligibility Criteria
Inclusion Criteria
- Active axial spondyloarthritis with disease duration ≤5 years, and chronic back pain of ≥3 month duration
- Have either an inadequate response to 30 days of optimal daily doses of at least one non-steroidal anti-inflammatory drug (NSAID) or must be unable to receive a full 30 day maximal NSAID therapy because of intolerance, toxicity or contraindications to NSAIDs
- Females of child-bearing potential must use contraception
- No history of untreated latent or active tuberculosis
Exclusion Criteria
- Fulfillment of modified New York criteria for ankylosing spondylitis
- Has ever received tumor necrosis factor (TNF)-α targeted therapy or any biological agents
- Any systemic inflammatory condition other than spondyloarthritis
- Serious infection within 2 months
- Any known malignancy or a history of malignancy within the previous 5 years
- Has or had a substance abuse (drug or alcohol) problem within the previous 2 years
Data sourced from ClinicalTrials.gov (NCT01453725). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.