A Safety and Efficacy Study of Golimumab (CNTO148) in Patients With Active Rheumatoid Arthritis (RA)

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 objective is to evaluate the pharmacokinetics of golimumab.

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 factor) a monoclonal antibody produced by mean of HuMab mouse technology. Other reasons for using the study design are as follows: the effects of golimumab given alone must be confirmed as in the case of other drugs; and golimumab may be used even in patients not on the treatment with MTX. CNTO148 50 mg group: CNTO148 50 mg SC injections every 4 weeks from the first administration until week 116 CNTO148 100 mg group: CNTO148 100 mg SC injections every 4 weeks from the first administration until week 116. Placebo group: Placebo SC injections every 4 weeks from the first administration until week 12 and then CNTO148 50mg SC injections every 4 weeks from week 16 until week 116

Inclusion Criteria:

• 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 Criteria:

• 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