Status:
COMPLETED
An Efficacy and Safety Study of CNTO 148 Subcutaneous Injection Compared With Placebo in Patients With Active Rheumatoid Arthritis
Lead Sponsor:
Centocor, Inc.
Collaborating Sponsors:
Centocor BV
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
Multicenter, randomized, double-blind, placebo-controlled, 5-arm, dose-ranging study to assess the efficacy of subcutaneous injections of Golimumab (CNTO 148), 50 or 100 mg, at either 2- or 4- week in...
Detailed Description
This is an experimental medical research study. The purpose of this study is to determine if Golimumab is safe and effective in the treatment of rheumatoid arthritis. Subjects will receive subcutaneo...
Eligibility Criteria
Inclusion
- Diagnosis of RA according to the American College of Rheumatology criteria for at least 3 months prior to screening
- Have active Rheumatoid Arthritis at the time of screening and at baseline, as defined by 6 or more swollen joints and 6 or more tender joints and additional laboratory criteria
Exclusion
- Have other inflammatory diseases, including but not limited to ankylosing spondylitis, systemic lupus erythematosus, Lyme disease
- Received disease-modifying antirheumatic drugs (\[DMARDs\] eg, D penicillamine, hydroxychloroquine, chloroquine, oral or parenteral gold, interleukin \[IL\]-1 receptor antagonist \[anakinra\], azathioprine, sulphasalazine, agents other than MTX) within 4 weeks prior to the first study dose
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2006
Estimated Enrollment :
172 Patients enrolled
Trial Details
Trial ID
NCT00207714
Start Date
November 1 2003
End Date
February 1 2006
Last Update
October 18 2012
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