- The patient has a diagnosis of RA based upon the American College of Rheumatology
(ACR) 1987 Revised Criteria.
- The patient has active disease at both Screening and Baseline, as defined by both: ≥6
joints tender or painful on motion; and ≥6 joints swollen; and fulfills 1 of the
following 2 criteria at Screening: 1.ESR (Westergren method) >28 mm in the local
laboratory. 2. CRP >7 mg/L in the central laboratory
- Patient had an inadequate response to at least one DMARD (traditional or biologic) due
to lack of efficacy or toxicity.
- No evidence of active or latent or inadequately treated infection with Mycobacterium
- Patient has washed out of all DMARDs other that antimalarials
- Blood dyscrasias including confirmed: 1. Hemoglobin White blood cell count Platelet count
- History of any other autoimmune rheumatic disease other than Sjogren's syndrome
- No malignancy or history of malignancy.
- History of infection requiring hospitalization, parenteral antimicrobial therapy, or
as otherwise judged clinically significant by the investigator, within the 6 months
prior to the first dose of study drug