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

• Vieira MC, Zwillich SH, Jansen JP, Smiechowski B, Spurden D, Wallenstein GV. Tofacitinib Versus Biologic Treatments in Patients With Active Rheumatoid Arthritis Who Have Had an Inadequate Response to Tumor Necrosis Factor Inhibitors: Results From a Network Meta-analysis. Clin Ther. 2016 Dec;38(12):2628-2641.e5. doi: 10.1016/j.clinthera.2016.11.004. Epub 2016 Nov 24.
• 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.
• Strand V, Burmester GR, Zerbini CA, Mebus CA, Zwillich SH, Gruben D, Wallenstein GV. Tofacitinib with methotrexate in third-line treatment of patients with active rheumatoid arthritis: patient-reported outcomes from a phase III trial. Arthritis Care Res (Hoboken). 2015 Apr;67(4):475-83. doi: 10.1002/acr.22453.
• 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.
• Burmester GR, Blanco R, Charles-Schoeman C, Wollenhaupt J, Zerbini C, Benda B, Gruben D, Wallenstein G, Krishnaswami S, Zwillich SH, Koncz T, Soma K, Bradley J, Mebus C; ORAL Step investigators. Tofacitinib (CP-690,550) in combination with methotrexate in patients with active rheumatoid arthritis with an inadequate response to tumour necrosis factor inhibitors: a randomised phase 3 trial. Lancet. 2013 Feb 9;381(9865):451-60. doi: 10.1016/S0140-6736(12)61424-X. Epub 2013 Jan 5.

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.