A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One TNF Inhibitor

Trial Profile

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Of The Efficacy And Safety Of 2 Doses Of Tofacitinib (CP-690,550) In Subjects With Active Psoriatic Arthritis And An Inadequate Response To At Least One TNF Inhibitor

Completed
Phase of Trial: Phase III

Latest Information Update: 14 Dec 2017

At a glance

  • Drugs Tofacitinib (Primary)
  • Indications Psoriatic arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms OPAL-BEYOND
  • Sponsors Pfizer
  • Most Recent Events

    • 14 Dec 2017 According to a Pfizer media release, Philip Mease, Swedish Medical Center, University of Washington is one of the study investigators.
    • 14 Dec 2017 According to a Pfizer media release, the US FDA has approved XELJANZ (tofacitinib) 5 mg twice daily (BID) and XELJANZ XR extended release 11 mg once daily (QD) for the treatment of adult patients with active psoriatic arthritis (PsA) who have had an inadequate response or intolerance to methotrexate or other disease-modifying antirheumatic drugs (DMARDs). The approval was based on data from the OPAL Beyond OPAL Broaden trials.
    • 08 Nov 2017 Results from OPAL Broaden and OPAL Beyond studies assessing the effects of tofacitinib treatment on several composite endpoints in patients with psoriatic arthritis, presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
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