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

• Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 May 20;3(1):30. doi: 10.1186/s41687-019-0115-4.
• van der Heijde D, Gladman DD, FitzGerald O, Kavanaugh A, Graham D, Wang C, Fallon L. Radiographic Progression According to Baseline C-reactive Protein Levels and Other Risk Factors in Psoriatic Arthritis Treated with Tofacitinib or Adalimumab. J Rheumatol. 2019 Sep;46(9):1089-1096. doi: 10.3899/jrheum.180971. Epub 2019 Mar 1.
• Strand V, de Vlam K, Covarrubias-Cobos JA, Mease PJ, Gladman DD, Graham D, Wang C, Cappelleri JC, Hendrikx T, Hsu MA. Tofacitinib or adalimumab versus placebo: patient-reported outcomes from OPAL Broaden-a phase III study of active psoriatic arthritis in patients with an inadequate response to conventional synthetic disease-modifying antirheumatic drugs. RMD Open. 2019 Jan 11;5(1):e000806. doi: 10.1136/rmdopen-2018-000806. eCollection 2019.
• Cella D, Wilson H, Shalhoub H, Revicki DA, Cappelleri JC, Bushmakin AG, Kudlacz E, Hsu MA. Content validity and psychometric evaluation of Functional Assessment of Chronic Illness Therapy-Fatigue in patients with psoriatic arthritis. J Patient Rep Outcomes. 2019 Jan 24;3(1):5. doi: 10.1186/s41687-019-0094-5. Corrected and republished in: J Patient Rep Outcomes. 2019 May 20;3(1):30. Retraction in: J Patient Rep Outcomes. 2019 May 28;3(1):32.
  
  Retraction in:J Patient Rep Outcomes. 2019 May 28;3(1):32
• Helliwell P, Coates LC, FitzGerald O, Nash P, Soriano ER, Elaine Husni M, Hsu MA, Kanik KS, Hendrikx T, Wu J, Kudlacz E. Disease-specific composite measures for psoriatic arthritis are highly responsive to a Janus kinase inhibitor treatment that targets multiple domains of disease. Arthritis Res Ther. 2018 Oct 29;20(1):242. doi: 10.1186/s13075-018-1739-0.
• Mease P, Hall S, FitzGerald O, van der Heijde D, Merola JF, Avila-Zapata F, Cie?lak D, Graham D, Wang C, Menon S, Hendrikx T, Kanik KS. Tofacitinib or Adalimumab versus Placebo for Psoriatic Arthritis. N Engl J Med. 2017 Oct 19;377(16):1537-1550. doi: 10.1056/NEJMoa1615975.

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