Three Dose Levels of CP-690,550 Monotherapy Versus Placebo, Administered Orally Twice Daily (BID) for 6 Weeks

• Drug: CP-690,550
  
  Oral tablets administered at a dose of 5 mg BID for 6 weeks
• Drug: CP-690,550
  
  Oral tablets administered at a dose of 15 mg BID for 6 weeks
• Drug: CP-690,550
  
  30 mg BID for 6 weeks
• Other: Placebo
  
  Placebo tablets

• Experimental: 5 mg BID
  
  CP 690,550 5 mg BID
  Intervention: Drug: CP-690,550
• Experimental: 15 mg BID
  
  CP 690,550 15 mg BID
  Intervention: Drug: CP-690,550
• Experimental: 30 mg BID
  
  Oral tablets administered at a dose of 30 mg BID for 6 weeks
  Intervention: Drug: CP-690,550
• Placebo Comparator: Placebo
  
  Placebo
  Intervention: Other: Placebo

• Cohen S, Radominski SC, Gomez-Reino JJ, Wang L, Krishnaswami S, Wood SP, Soma K, Nduaka CI, Kwok K, Valdez H, Benda B, Riese R. Analysis of infections and all-cause mortality in phase II, phase III, and long-term extension studies of tofacitinib in patients with rheumatoid arthritis. Arthritis Rheumatol. 2014 Nov;66(11):2924-37. doi: 10.1002/art.38779.
• Kremer JM, Bloom BJ, Breedveld FC, Coombs JH, Fletcher MP, Gruben D, Krishnaswami S, Burgos-Vargas R, Wilkinson B, Zerbini CA, Zwillich SH. The safety and efficacy of a JAK inhibitor in patients with active rheumatoid arthritis: Results of a double-blind, placebo-controlled phase IIa trial of three dosage levels of CP-690,550 versus placebo. Arthritis Rheum. 2009 Jul;60(7):1895-905. doi: 10.1002/art.24567. Erratum in: Arthritis Rheum. 2012 May;64(5):1487.

Inclusion Criteria:

• The subject has a history of inadequate response to at least 1, but no more than 4, of the following DMARDs: sulfasalazine, injectable gold, methotrexate, leflunomide, cyclosporine, or a thiopurine derivative (azathioprine or 6-mercaptopurine)

Exclusion Criteria:

• Current Therapy With Any DMARD Or Biologic