Status:
COMPLETED
A Study of Safety and Effectiveness of Golimumab in Participants With Active Rheumatoid Arthritis Despite Methotrexate Therapy
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 assess the clinical effectiveness and safety of golimumab intravenous (IV) infusions every 12 weeks with or without Methotrexate (MTX), compared with MTX alone, in pati...
Detailed Description
This is a Phase III, double blind (neither investigator nor participant knows the treatment received), placebo-controlled (an inactive substance that is compared with the study medication to test whet...
Eligibility Criteria
Inclusion
- \- Must have a diagnosis of active rheumatoid arthritis (RA) (according to the revised 1987 criteria of the ARA (American Rheumatism Association) with at least 4 swollen and 4 tender joints for at least 3 months prior to screening - Have been treated with and tolerated methotrexate (MTX) at a dose of at least 15 mg per week for at least 3 months prior to screening - Have been on a stable MTX dose of greater than or equal to 15 mg per week and less than or eual to 25 mg per week for at least 4 weeks prior to screening - If using non steroidal anti-inflammatory agents (such as naproxen) or other pain relievers for RA, must be on a stable dose for at least 2 weeks prior to the first administration of study agent
Exclusion
- \- Participants having known hypersensitivity (severe allergy) to human immunoglobulin proteins or other components of golimumab - Having known clinically serious adverse reaction to a biologic anti-TNF agent - Have had history of latent or active granulomatous infection, including tuberculosis, histoplasmosis, or coccidioidomycosis, prior to screening
Key Trial Info
Start Date :
September 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2009
Estimated Enrollment :
643 Patients enrolled
Trial Details
Trial ID
NCT00361335
Start Date
September 1 2006
End Date
September 1 2009
Last Update
July 29 2014
Active Locations (72)
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1
Peoria, Arizona, United States
2
Aventura, Florida, United States
3
Orlando, Florida, United States
4
Tampa, Florida, United States