Status:
COMPLETED
Effect of Golimumab in Participants With Active Axial Spondyloarthritis (P07642, MK-8259-006)
Lead Sponsor:
Merck Sharp & Dohme LLC
Collaborating Sponsors:
Johnson & Johnson
Conditions:
Spondylitis, Ankylosing
Eligibility:
All Genders
18-45 years
Phase:
PHASE3
Brief 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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 13 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 15 2015
Estimated Enrollment :
198 Patients enrolled
Trial Details
Trial ID
NCT01453725
Start Date
February 13 2012
End Date
January 15 2015
Last Update
February 6 2019
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