5449W-13: Mease Pfizer A3921091

Efficacy And Safety Of Tofacitinib In Psoriatic Arthritis: Comparator Study (OPAL BROADEN)

Type of Study
Rheumatology - Psoriatic Arthritis
Short Description

This is a 12 month study investigating the effectiveness and safety of tofactinib in treating the signs and symptoms, improving physical function and preserving bone structure in patients with active psoriatic arthritis and had inadequate response to a traditional, non-biologic disease modifying anti-rheumatic drug. Adalimumab is use as a comparator.


Status
Open
Principal Investigator
Philip J. Mease, MD
Eligibility Notes

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
Start Date
9/11/2013
Contact Name
Allison Everett
Phone
206-386-3201
Alternate Phone
206-386-6248
Email
Allison.Everett@swedish.org
Alternate Email
Sephren.Barrow@swedish.org