To assess the relative risk for serious infection in infliximab-treated patients within the first 22 weeks after initiation of therapy in a population of patients with rheumatoid arthritis (RA) reflective of the demographics (severity of RA, background disease-modifying anti-rheumatic drugs, concomitant diseases) seen in clinical practice.

Ages Eligible for Study:  18 Years and above,  Genders Eligible for Study:  Both

Criteria

Inclusion Criteria

• 18 years or older
• diagnosis of RA at least 3 months before screening using revised 2000 criteria of the American Rheumatism Association
• active RA (at least 6 swollen and 6 tender joints due to RA)
• concomitant MTX treatment of 25 mg/kg for > 3 months stable dose for at least 4 weeks prior to week 0 stable dose of other concomitant medications
• chest X-ray and tuberculosis screening

Exclusion Criteria

• pregnancy, nursing or planning pregnancy within 18 months of enrollment
• have a rheumatic disease other than RA or any current systemic inflammatory conditions with signs and symptoms that might confound the evaluations from the Infliximab therapy
• previous treatment with any approved or investigational biologic agent (except vaccines for immunizations)
• treated with any investigational drug within the previous 3 months or within 5 half-lives, whichever is greater
• previous or current use of cyclophosphamide, nitrogen mustard, chlorambucil, or other alkylating agents
• currently on > 5 mg cyclosporine treatment
• history of any clinically significant adverse reaction to murine or chimeric proteins
• have had a serious infection in the previous 2 months
• have active TB
• have history of active TB without having completed a course of anti-tubercular therapy at least 2 years prior to the baseline visit
• have positive skin-test and refuses prophylaxis for tuberculosis
• have a history of chronic or recurrent infectious disease
• have a serious illness that is rapidly worsening or might deteriorate over the course of the study
• have a history of or signs suggestive of lymphoproliferative disease or signs
• have known malignancy or history of malignancy within the previous 5 years
• have had substance abuse (drug or alcohol) within the previous 3 years
• unable or unwilling to undergo multiple venipunctures
• have current side effects related to MTX
• have a concomitant diagnosis of CHF, including medically controlled asymptomatic patients