Status:
COMPLETED
Study of Subcutaneous Golimumab in Chinese Patients 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 evaluate the safety and efficacy of golimumab in Chinese patients with rheumatoid arthritis.
Detailed Description
Golimumab is a type of tumor necrosis factor (TNF)-inhibitor. TNF is a naturally occurring substance in the body, and this substance may cause long-term inflammation. Golimumab may help fight disease ...
Eligibility Criteria
Inclusion
- \- Diagnosis of rheumatoid arthritis for at least 6 months
- Be on a stable dose of methotrexate for 4 weeks
- Have at least 4 swollen and 4 tender joints
Exclusion
- Prior exposure to biologic anti-TNFalpha agents
- Inflammatory diseases other than rheumatoid arthritis
- Treatment with Disease Modifying Anti-rheumatic drug (DMARDs)/systemic immunosuppressives other than methotrexate during the 4 weeks prior to the first administration of study agent
- History of, or ongoing, chronic or recurrent infectious disease
Key Trial Info
Start Date :
September 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
264 Patients enrolled
Trial Details
Trial ID
NCT01248780
Start Date
September 1 2010
End Date
July 1 2012
Last Update
September 6 2013
Active Locations (9)
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1
Beijing, China
2
Chengdu, China
3
Hefei, China
4
Jinan, China