1. Subject has a minimum 1 year history/diagnosis of rheumatoid arthritis based on the
1987 American College of Rheumatology (ACR) Revised criteria for RA.
2. Subject must have active rheumatoid arthritis despite methotrexate (MTX) therapy of
≥10 mg/wk for at least 12 weeks. The MTX dose must be stable for at least 4 weeks
immediately prior to screening.
1. Subjects who used any of the following systemic treatments during the washout periods
given below:
1. Oral corticosteroid dose of prednisone >7.5 mg/day (or equivalent) or a change in
dose within 28 days of baseline.
2. Treatment with more than 1 NSAID within 14 days at baseline.
3. Methotrexate dose greater than 25 mg/week, or change in the dose of methotrexate
within 28 days of baseline.
4. Subjects will be allowed to continue the following non biologic DMARDs:
sulfasalazine, hydroxychloroquine, and leflumomide. All other non-biologic DMARDs
(including but not limited to gold, penicillamine, azathioprine,
cyclophospamide), and biologic DMARDs must have been discontinued at least 2
months prior to Week 1.
5. Any biologic B cell depleting agent (eg, rituximab) within 2 years of Week 1.
2. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.
3. Receipt of any live (attenuated) vaccine within 4 weeks prior to baseline.