Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study

• Drug: Tofacitinib 5 mg BID
  
  Tofacitinib orally (po) 1 tablet of 5 mg and placebo po 1 tablet BID x 12 months Placebo injections subcu every 2 weeks x 12 months
• Drug: Tofacitinib 10 mg BID
  
  Tofacitinib po 2 tablets of 5 mg BID x 12 months Placebo injections subcu every 2 weeks x 12 months
• Drug: Adalimumab
  
  Placebo po 2 tablets BIDx 12 months Adalimumab 40 mg subcu injections every 2 weeks x 12 months
• Drug: Placebo
  
  Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 1 tablet of 5 mg and placebo po 1 tablet BID x 9 months Placebo injections every 2 weeks x 12 months
• Drug: Placebo
  
  Placebo po 2 tablets BIDx 3 months followed by tofacitinib po 2 tablets (5 mg) BID x 9 months Placebo injections every 2 weeks x 12 months

• Experimental: Tofacitinib 5 mgBID x 12 months
  
  Intervention: Drug: Tofacitinib 5 mg BID
• Experimental: Tofacitinib 10 mg BID x 12 months
  
  Intervention: Drug: Tofacitinib 10 mg BID
• Active Comparator: Adalimumab 40 mg q2 weeks x 12 months
  
  Intervention: Drug: Adalimumab
• Placebo Comparator: Placebo x3 months, then tofacitinib 5 mg BIDx 9 months
  
  Intervention: Drug: Placebo
• Placebo Comparator: Placebo x 3 months, then tofacitinib 10 mg BID x 9 months
  
  Intervention: Drug: Placebo

Inclusion Criteria:

• Males or females, aged >= 18 years at time of consent.
• Have a diagnosis of Psoriatic arthritis (PsA) of >= 6 months
• Meet the Classification Criteria of PsA (CASPAR) at time of screening
• Must not have been adequately treated with a a traditional non-biologic disease modifying anti-rheumatic drug (DMARD).
• Concurrent treatment with methotrexate, leflunomide, or sulfasalazine allowed and required
• Must not have taken a biologic Tumour Necrosis Factor Inhibitor
• Must have 3 or more swollen joints AND 3 or more tender joints
• Must have active psoriasis skin lesions

Exclusion Criteria:

• Have non-plaque forms of psoriasis, eg erythrodermic, guttate or pustular, with the exception of nail psoriasis which is allowed
• Pregnant or breast feeding, females of child-bearing potential not using highly effective contraception
• New York Heart Association Class III and IV congestive heart failure
• History of hypersensitivity or infusion reaction to biologic agents
• Infection with HIV, hepatitis B virus, hepatitis C virus, or other chronic infection