Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642 AM2)
| Status: | Completed |
|---|---|
| Conditions: | Neurology, Orthopedic |
| Therapuetic Areas: | Neurology, Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 45 |
| Updated: | 11/23/2013 |
| Start Date: | February 2012 |
| End Date: | January 2015 |
| Contact: | Toll Free Number |
| Phone: | 1-888-577-8839 |
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-8259-006-00).
This two-part study will evaluate the effect of golimumab in participants with active axial
spondyloarthritis. In Part 1, participants will 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 will not know the identity of the injection. In the Part 2 extension all
participants receive golimumab 50 mg subcutaneous injections beginning on Week 16 and then
every 4 weeks up to Week 48. In Part 2 the participants will be told they are receiving
active study drug.
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)
- 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
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