A Phase 3 Study Comparing 2 Doses Of CP-690,550 And The Active Comparator, Humira (Adalimumab) Vs. Placebo For Treatment Of Rheumatoid Arthritis

• Drug: CP 690,550
  
  tablets 5 mg BID PO plus q2 week placebo SC injections for 12 months
• Drug: CP-690,550
  
  tablets 10 mg BID PO plus q2 week placebo SC injections for 12 months
• Other: Placebo
  
  placebo tablets BID PO advance to 5mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
• Other: Placebo
  
  tablets BID PO advance tablets to10mg CP 690,550 BID at Month 3 or 6 visit plus q2 week placebo SC injections for 12 months
• Biological: Biologic TNFi
  
  placebo tablets BID PO plus adalimumab 40 mg q2 week SC injections for 12 months
  Other Name: Humira (Adalimumab)

• Experimental: 5mg
  
  Intervention: Drug: CP 690,550
• Experimental: 10 mg
  
  Intervention: Drug: CP-690,550
• Placebo Comparator: Placebo Sequence 1
  
  Intervention: Other: Placebo
• Placebo Comparator: Placebo Sequence 2
  
  Intervention: Other: Placebo
• Active Comparator: adalimumab
  
  Intervention: Biological: Biologic TNFi

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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 must have had an inadequate response to methotrexate and have active disease, 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.
• No evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis.
• The patient must have been on a stable dose of 7.5 mg to 25 mg weekly of methotrexate and washed out of all other DMARDs.

Exclusion Criteria:

• Blood dyscrasias including confirmed: 1. Hemoglobin <9 g/dL or Hematocrit <30%; 2. White blood cell count <3,000 cu.mm. Absolute neutrophil count <1,200 cu.mm; 4. Platelet count <100,000/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
• Patients who have failed any TNFi for either lack of efficacy or a TNFi mechanism related adverse event.
• Patients who have previously received adalimumab therapy for any reason.
• Patients who are contraindicated for treatment with adalimumab in accordance with the approved local label.
• Patients meeting the New York Heart Association Class III and Class IV Congestive Heart failure