Study of CP-690,550 Versus Placebo In Rheumatoid Arthritis Patients On Background Methotrexate With Inadequate Response To Tumor Necrosis Factor (TNF) Inhibitors

• Drug: CP-690,550
  Oral tablets administered at 5 mg BID daily for 6 months during the double-blind, placebo-controlled period.
• Drug: CP-690,550
  Oral tablets administered at 10 mg BID daily for 6 months during the double-blind, placebo-controlled period.
• Drug: Placebo
  Oral placebo tablets administered BID daily during the first 3 months of the double-blind, study period.
  Other Name: double-blind, placebo-controlled phase
• Drug: CP-690,550
  Oral tablets administered at 5 mg BID daily during the second 3 months of the double-blind, study period.
  Other Name: double-blind, extension phase
• Drug: Placebo
  Oral placebo tablets administered BID daily during the first 3 months of the double-blind, placebo-controlled period.
  Other Name: double-blind, placebo-controlled phase
• Drug: CP-690,550
  Oral tablets administered at 10 mg BID daily during the second 3 months of the double-blind, study period.
  Other Name: double-blind, extension phase

• Experimental: Sequence 1
  Intervention: Drug: CP-690,550
• Experimental: Sequence 2
  Intervention: Drug: CP-690,550
• Placebo Comparator: Sequence 3
  Interventions:

  • Drug: Placebo
  • Drug: CP-690,550
• Placebo Comparator: Sequence 4
  Interventions:

  • Drug: Placebo
  • Drug: CP-690,550

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• Charles-Schoeman C, Burmester G, Nash P, Zerbini CA, Soma K, Kwok K, Hendrikx T, Bananis E, Fleischmann R. Efficacy and safety of tofacitinib following inadequate response to conventional synthetic or biological disease-modifying antirheumatic drugs. Ann Rheum Dis. 2016 Jul;75(7):1293-301. doi: 10.1136/annrheumdis-2014-207178. Epub 2015 Aug 14. Erratum in: Ann Rheum Dis. 2017 Mar;76(3):611.
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Inclusion Criteria:

• Adults with moderate to severe rheumatoid arthritis on a stable dose of methotrexate who have inadequate response to Tumor Necrosis Factor (TNF) inhibitors.

Exclusion Criteria:

• Pregnancy, severe acute or chronic medical conditions, including serious infections or clinically significant laboratory abnormalities.