Status:
COMPLETED
A Study of the Safety and Efficacy of Golimumab in Subjects With Rheumatoid Arthritis That Are Methotrexate-naive
Lead Sponsor:
Centocor, Inc.
Collaborating Sponsors:
Schering-Plough
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of golimumab, alone or in combination with methotrexate, as compared to methotrexate alone in rheumatoid arthritis subjects who have no...
Detailed Description
Golimumab is a fully human protein (antibody) which binds to tumor necrosis factor (TNFa). TNFa is increased in patients with rheumatoid arthritis (RA), and plays a major role in causing the joint pai...
Eligibility Criteria
Inclusion
- Have a diagnosis of rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ACR) for at least 3 months prior to first administration of study agent
- Are methotrexate (MTX)-naïve (ie, have not received more than 3 weekly doses of MTX for RA at any time)
- Have active RA as defined by persistent disease activity with at least 4 swollen and 4 tender joints, at the time of screening and baseline, and at least 2 of the following 4 criteria: a) C-reactive protein (CRP) \>=1.5 mg/dL at screening or erythrocyte sedimentation rate (ESR) by Westergren method of \>= 28 mm in the first hour at screening or baseline, b)Morning stiffness of \>= 30 minutes at screening and baseline, c)Bone erosion by x-ray and/or MRI prior to first administration of study agent, d)Anti-cyclic citrullinated peptide (anti-CCP) antibody-positive or rheumatoid factor (RF) positive at screening
- If using oral corticosteroids, must be on a stable dose equivalent to \<= 10 mg of prednisone/day for at least 2 weeks prior to first administration of study agent.
Exclusion
- Can not have inflammatory diseases other than RA that might confound the evaluation of the benefit of golimumab therapy
- No treatment with disease-modifying anti-rheumatic drugs (DMARDs)/systemic immunosuppressives during the 4 weeks prior to the first administration of study agent
- No prior treatment with biologic anti-TNF drugs (infliximab, etanercept, adalimumab)
- No history of, or ongoing, chronic or recurrent infectious disease
- No serious infection within 2 months prior to first administration of study agent.
Key Trial Info
Start Date :
December 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2012
Estimated Enrollment :
637 Patients enrolled
Trial Details
Trial ID
NCT00264537
Start Date
December 1 2005
End Date
June 1 2012
Last Update
September 5 2014
Active Locations (75)
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1
Birmingham, Alabama, United States
2
Mobile, Alabama, United States
3
Upland, California, United States
4
Jacksonville, Florida, United States