A Study to Assess Immune Response Following Zoster Vaccination to Subjects With Rheumatoid Arthritis Receiving Tofacitinib or Placebo With Background Methotrexate

• Drug: Tofacitinib
  
  5 mg twice daily of tofacitinib with background methotrexate for 12 weeks
• Drug: Placebo
  
  Placebo tablets twice daily with background methotrexate for 12 weeks

• Experimental: Tofacitinib 5 mg BID (oral) (70 subjects)
  
  Zoster vaccine will be administered to subjects on background methotrexate; treatment with 5 mg tofacitinib twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.
  Intervention: Drug: Tofacitinib
• Placebo Comparator: Placebo tofacitinib BID (oral) (70 subjects)
  
  Zoster vaccine will be administered to subjects on background methotrexate; treatment with placebo twice daily will begin 2 to 3 weeks following vaccination and continue for 12 weeks.
  Intervention: Drug: Placebo

Inclusion Criteria:

• Subjects must have moderate to severe rheumatoid arthritis inadequately controlled by methotrexate as defined by the American College of Rheumatology (ACR) classification criteria for Rheumatoid arthritis, painful and swollen joint counts and C-reactive protein (CRP).
• Screening CRP >3 mg/L or CDAI score > 10 at screening or at baseline before vaccination.
• Subjects must have active disease at screening and baseline.
• Must be at least 50 years of age or older.

Exclusion Criteria:

• History of receiving any varicella-zoster virus vaccine
• Receipt of any vaccines within 6 weeks of first dose of study treatment.
• Subjects with current infections or history of infections.
• History of recurrent (more than one episode) of herpes zoster or disseminated (a single episode) of herpes zoster or disseminated (a single episode) of herpes simplex.