Status:
COMPLETED
A Study of the Safety and Efficacy of Golimumab in Subjects With Active Ankylosing Spondylitis
Lead Sponsor:
Centocor, Inc.
Collaborating Sponsors:
Schering-Plough
Conditions:
Spondylitis, Ankylosing
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of subcutaneous injections (under the skin) of golimumab for the treatment of active ankylosing spondylitis \[AS(arthritis of the spine...
Detailed Description
Anti-tumor necrosis factor (TNF) agents have been shown to be effective treatment for patients with active ankylosing spondylitis (arthritis of the spine) who have not responded to conventional therap...
Eligibility Criteria
Inclusion
- Diagnosis of "Definite AS" (arthritis of the spine) as defined by the modified New York criteria, for at least 3 months prior to first dose of study drug
- Symptoms of active disease at screening and at baseline visits, as evidenced by both a Bath Ankylosing Spondylitis Disease Activity Index (BASDAI) score of \>= 4, and a Total Back Pain score of \>= 4 (each on a scale of 0 to 10cm)
- Inadequate response to 3 months of continuous therapy with maximal recommended doses of NSAIDs, or else unable to receive a full 3 months of maximal NSAID therapy because of intolerance, toxicity, or contraindications to non-steroidal anti-inflammatory drugs (NSAIDs)
- Stable doses of methotrexate, sulfasalazine, hydroxychloroquine, low-dose corticosteroids, and NSAIDs are permitted.
Exclusion
- Patients cannot have complete ankylosis of the spine
- No prior treatment with biologic anti-TNF agents (infliximab, etanercept, adalimumab)
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2012
Estimated Enrollment :
356 Patients enrolled
Trial Details
Trial ID
NCT00265083
Start Date
December 1 2005
End Date
January 1 2012
Last Update
July 19 2013
Active Locations (39)
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1
Paradise Valley, Arizona, United States
2
Los Angeles, California, United States
3
San Francisco, California, United States
4
Ormond Beach, Florida, United States