A Phase 3 Study Comparing 2 Doses of CP-690,550 vs. Placebo for Treatment of Rheumatoid Arthritis

• Drug: CP-690,550
  
  5mg CP-690,550 BID PO for 6 months
• Drug: CP-690,550
  
  10 mg CP-690,550 BID PO for 6 months
• Drug: Placebo
  
  Placebo patients advance to 5mg CP-690,550 BID at Month 3 visit
• Drug: Placebo
  
  Placebo patients advance to 10mg CP-690,550 BID at Month 3 visit

• Experimental: Active 5mg
  
  Intervention: Drug: CP-690,550
• Experimental: Active 10 mg
  
  Intervention: Drug: CP-690,550
• Placebo Comparator: Placebo Sequence 1
  
  Intervention: Drug: Placebo
• Placebo Comparator: Placebo Sequence 2
  
  Intervention: Drug: Placebo

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Inclusion Criteria:

• 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 tuberculosis.
• Patient has washed out of all DMARDs other that antimalarials

Exclusion Criteria:

• Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3.0 x 109/L; 3. Absolute neutrophil count <1.2 x 109/L; 4. Platelet count <100 x 109/L
• 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