A Study Evaluating 10 mg and 25 mg Doses of Etanercept in Patients With Rheumatoid Arthritis

A Randomized, Double-Blind, Multicenter, Parallel Study Evaluating the Safety and Efficacy of Etanercept 10 mg Twice Weekly and 25 mg Once Weekly in Japanese Subjects With Active Rheumatoid Arthritis

This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

This study will compare the safety and efficacy for two regimens of etanercept in patients with rheumatoid arthritis (RA). The two regimens to be compared are a 25mg twice weekly regimen and a 50mg once weekly regimen.

Inclusion Criteria:

• Presence of >6 swollen joints and >6 tender joints
• Inadequate response to at least one disease modifying anti-rheumatic drug (DMARD)
• Have not been treated with a DMARD for at least 4 weeks prior to the baseline visit

Exclusion Criteria:

• Previous treatment with etanercept, antibody to TNFα, or other TNFα inhibitors
• Received investigational drugs within 6 months of the baseline visit
• Received intra-articular hyaluronic acid injections within 4 weeks of the baseline visit