Status:
COMPLETED
A Safety and Efficacy Study of Golimumab (CNTO 148) in Patients With Active Rheumatoid Arthritis Despite Methotrexate Therapy
Lead Sponsor:
Janssen Pharmaceutical K.K.
Collaborating Sponsors:
Tanabe Pharma Corporation
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
20-74 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of golimumab in patients with active rheumatoid arthritis despite Methotrexate therapy. Another objective is to evaluate the pharm...
Detailed Description
This clinical study is scheduled to be performed for the purpose of evaluating the safety and effectiveness of golimumab (CNTO148) administered in combination with stable dose (6-8mg/week) of methotre...
Eligibility Criteria
Inclusion
- Patients diagnosed with rheumatoid arthritis at least 3 months prior to registration and who are definitely identified as having rheumatoid arthritis, at the time of informed consent, according to the criteria for classification established by the American College of Rheumatology (1987)
- Patients in whom MTX therapy (\>= 6 mg/week) was started more than 3 months before the first administration and who have been treated with MTX at a stable dose (6-8 mg/week) for at least 4 weeks before the first administration
- Patients having at least 4 swollen joints and at least 4 tender joints at the time of registration and immediately before the first administration.
Exclusion
- Patients with a history of hypersensitivity to human immunoglobulin proteins or other ingredients of golimumab
- Patients who have previously experienced or are suffering from any of the following diseases: (i) Collagen diseases other than rheumatoid arthritis, (ii) Latent or active granulomatous infections such as histoplasmosis and coccidioidomycosis, (iii) Felty syndrome, etc
- Patients with a severe, advanced, or poorly controlled disease in any of the kidney, liver, blood, gastrointestinal system, endocrine system, lung, heart, nervous system, psychiatric system, and brain.
Key Trial Info
Start Date :
May 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
269 Patients enrolled
Trial Details
Trial ID
NCT00727987
Start Date
May 1 2008
End Date
December 1 2011
Last Update
May 23 2013
Active Locations (65)
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1
Asahi, Japan
2
Asahikawa, Japan
3
Azumino, Japan
4
Chiba, Japan