Overview

This trial is active, not recruiting.

Condition spondylitis, ankylosing
Treatments golimumab, placebo
Phase phase 3
Target TNF-alpha
Sponsor Merck Sharp & Dohme Corp.
Collaborator Johnson & Johnson
Start date February 2012
End date March 2014
Trial size 200 participants
Trial identifier NCT01453725, MK-8259-006; 2011-000311-34, P07642

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Experimental)
Part 1 of the study is blinded. Participants will receive open-label golimumab beginning at Week 16 (Part 2)
golimumab
50 mg subcutaneous injection every 4 weeks
(Placebo Comparator)
Part 1 of the study is blinded. Participants will receive open-label golimumab beginning at Week 16 (Part 2)
placebo
Placebo subcutaneous injection every 4 weeks

Primary Outcomes

Measure
Number of Participants Meeting the Assessment in Ankylosing Spondylitis (ASAS) 20 Response at Week 16
time frame: Week 16

Secondary Outcomes

Measure
Number of Participants Meeting the Assessment in Ankylosing Spondylitis (ASAS) 40 Response at Week 16
time frame: Week 16
Number of Participants Achieving Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) 50 at Week 16
time frame: Week 16
Number of Participants in ASAS Partial Remission at Week 16
time frame: Week 16
Change in Spondyloarthritis Research Consortium of Canada (SPARCC) Magnetic Resonance Imaging (MRI) Sacro-iliac Joints Scoring from Baseline
time frame: Baseline and Week 16

Eligibility Criteria

Male or female participants from 18 years up to 45 years old.

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

Additional Information

Official title 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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Merck Sharp & Dohme Corp..