A Study to Evaluate the Effectiveness of Infliximab and Changes in Hand and Wrist Magnetic Resonance Imaging (MRI) in Participants With Active Rheumatoid Arthritis (RA) (P08136)

Inclusion criteria

• Must have a clinical diagnosis of rheumatoid arthritis for at least 6 months
• Must have at least 6 tender joints AND 6 swollen joints
• Has a C-reactive protein ≥ 1.0 mg/L OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
• Baseline MRI must show evidence of synovitis in the wrist
• Must have screening laboratory tests within acceptable levels
• Women of childbearing potential and all men must agree to use a medically accepted method of contraception prior to entering the study and continue throughout study up to 6 weeks after study completion
• Must meet tuberculosis (TB) screening criteria
• Have received methotrexate therapy for ≥ 3 months; dose must be stable for at least 8 weeks
• If taking the a disease modifying anti-rheumatic drug (DMARD) in combination with methotrexate must be on a stable dose
• Must have a clinically acceptable 12 lead electrocardiogram (ECG)
• If taking oral corticosteroids must be on a stable dose equivalent to ≤10 mg of prednisone (or prednisolone) per day for ≥2 weeks
• If taking daily non-steroidal anti-inflammatory drug (NSAID) must be on a stable dose for ≥2 weeks; if taking NSAID on an as-needed basis must agree to discontinue use for at least 3 days and use only acetaminophen for breakthrough pain for 3 days before each MRI and clinic visit
• If received biological therapies, the last dose of these drugs was to be received ≥ 3 months prior to the baseline visit AND the reason for discontinuations was not for safety considerations OR lack of efficacy

Exclusion criteria

• Are pregnant, intend to become pregnant, or are breastfeeding
• Has inflammatory arthritis other than RA
• Has uncontrolled hypertension
• Has moderate or severe congestive heart failure
• Has a history of or current signs and/or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease
• Has a history of demyelinating disease or symptoms suggestive of multiple sclerosis or optic neuritis
• Is currently participating in another clinical study or have participated in a clinical study (e.g., laboratory or clinical evaluation) within 4 weeks
• Has history of any tumor with the exception of adequately treated basal cell carcinoma or carcinoma in situ of the cervix
• Has a history of any latent or active granulomatous infection including histoplasmosis, or coccidiomycosis
• Had a non-tuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, Pneumocystis carinii, aspergillosis) within 6 months
• Has a history of an infected joint prosthesis which has not been removed or replaced
• Has a known hypersensitivity to human immunoglobulin proteins or other components of infliximab
• Has received rituximab or natalizumab
• Has known claustrophobia or other contraindication to MRI
• Does not meet washout period guidelines for previous treatments/injections/vaccinations