Moderate Rheumatoid Arthritis (RA) With Etanercept (Enbrel)

A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Subjects With Moderately Active Rheumatoid Arthritis Despite DMARD Therapy

This study is designed to evaluate the effectiveness of adding etanercept to disease modifying anti-rheumatic drug (DMARD) therapy in patients with moderately active Rheumatoid Arthritis (RA).

Inclusion Criteria:

• Male or female ≥18 and ≤80 years of age at time of screening
• Diagnosed with rheumatoid arthritis as determined by meeting 1987 American College of Rheumatology (ACR) classification criteria and has had rheumatoid arthritis for at least 6 months
• Moderate rheumatoid arthritis during screening, as defined by a disease activity score (28 joint) calculated using the C-reactive protein formula (DAS28-CRP) > 3.2 and ≤ 5.1
• Active rheumatoid arthritis defined as ≥ 3 swollen joints (out of 28 joints examined) and ≥ 3 tender/painful joints (out of 28 joints examined) at screening and baseline. (A full 66/68 count joint count will be performed at baseline, but only joints in the 28-count joint count will be considered for eligibility. The 28-joint count consists of the finger joints excluding the distal interphalangeal joints, the wrists, elbows, shoulders, and knees)
• Must be currently taking a DMARD such as methotrexate, sulfasalazine, leflunomide, minocycline, and/or hydroxychloroquine

Exclusion Criteria:

• Prosthetic joint infection within 5 years of screening or native joint infection within 1 year of screening
• Class IV rheumatoid arthritis according to ACR revised response criteria
• Any active infection (including chronic or localized infections) for which anti-infectives were indicated within 28 days prior to first investigational product dose
• Previously used more than one experimental biologic DMARD. Patient with prior use of no more than one experimental biologic is permitted if the subject received no more than 8 weeks of treatment. The use of the experimental biologic must not have occurred within 2 months of the first dose of investigational product
• Previously used more than one commercially available biologic DMARD. Subject with prior use of no more than one commercially available biologic is permitted if the patient received no more than 8 weeks of treatment and did not discontinue because of lack of effect. The use of the biologic must not have occurred within 2 months of the first dose of investigational product. Acceptable prior use of biologics include the following examples:
• No more than 4 injections of adalimumab
• No more than 8 (50 mg) injections of etanercept
• No more than 2 infusions of infliximab
• No more than 2 infusions of abatacept
• Additional inclusion (exclusion) criteria may apply