Anti-TNF Agents for the Treatment of Rheumatoid Arthritis

Inclusion Criteria:

• Diagnosis of RA*
• Disease duration as defined from the onset of symptoms of at least 3 months prior tostudy entry
• Active RA with DAS28 > 4.4, clinically requiring the addition of anti-TNF therapy
• Stable dose of MTX between 7.5 mg and 25 mg weekly for at least 8 weeks prior to studyentry
• Able and willing to self-administer subcutaneous injections or have availablequalified person(s) or caregiver to administer subcutaneous injections
• For females, agree to use accepted methods of contraception during the duration of thestudy and for 150 days after study completion*. *More information on these criterioncan be found in the protocol.

Exclusion Criteria:

• Positive PPD test - a tuberculosis (TB) skin test: (> 5 mm induration regardless ofprior Bacille Calmette-Guerin [BCG] vaccine administration) without evidence ofongoing treatment for at least 30 days or completed treatment
• History of positive PPD or chest x-ray findings indicative of prior TB infection,without documentation of either treatment for TB infection or chemoprophylaxis for TBexposure
• Prednisone dose > 10 mg/day (or equivalent dose of another corticosteroid) within 30days prior to study entry
• Definitive diagnosis of another autoimmune disease that may require immunosuppressionfor treatment*
• Concomitant use of DMARDSs (e.g., disease-modifying antirheumatic drugs)*
• Any immunosuppressive therapy other than MTX, NSAIDs, or corticosteroids*
• Current or previous use of any biologic agent
• Presence of open leg ulcers
• Chronic or persistent infection that might be worsened by immunosuppressive treatment*
• Active infection or severe infections requiring hospitalization or treatment withintravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior tostudy entry
• Received oral antibiotics, antivirals, or antifungals within 14 days prior to studyentry
• Certain abnormal laboratory values*
• Any medical condition that, in the opinion of the investigator, would interfere withthe study
• History of malignancy other than treated localized carcinoma in situ of the cervix oradequately treated non-metastatic squamous or basal cell skin carcinoma within 10years prior to study entry
• Any Investigational agent within the earlier of 4 weeks or 5 half-lives prior to studyentry
• History of drug or alcohol abuse within 6 months prior to study entry
• Known allergy or hypersensitivity to study products
• Inability or unwillingness to follow the protocol
• Any condition or treatment that, in the opinion of the investigator, places theparticipant at an unacceptable risk
• Pregnant or breastfeeding *More information on these criterion are in the protocol.