Status:
COMPLETED
A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)
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 DMARD (Disease-modifying antirheumatic drugs) therapy. Another o...
Detailed Description
This study is designed as a placebo-controlled study of golimumab monotherapy for the purpose of demonstrating the safety and effectiveness of golimumab, a new, fully human anti-TNF (Tumor necrosis fa...
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 who have previously not responded to at least one DMARD (before informed consent is obtained)
- Patients who, if they are on the treatment with a DMARD, the DMARD can be washed out for at least 4 weeks before the first administration
- Patients having at least 6 swollen joints and 6 tender joints at the time of registration and immediately before the first injection
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 :
October 1 2011
Estimated Enrollment :
311 Patients enrolled
Trial Details
Trial ID
NCT00771251
Start Date
May 1 2008
End Date
October 1 2011
Last Update
November 3 2015
Active Locations (67)
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1
Asahikawa, Japan
2
Ayauta, Japan
3
Azumino, Japan
4
Chiba, Japan