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: 03 Aug 2017

At a glance

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

    • 03 Aug 2017 According to a Pfizer media release, the Arthritis Advisory Committee (AAC) of the US FDA has voted 10 to 1 to recommend approval of the supplemental New Drug Application for tofacitinib (XELJANZ) 5 mg twice daily and XELJANZ XR extended release 11 mg once daily (QD).
    • 17 Jun 2017 Results from 2 phase 3 studies (NCT01877668 and NCT01882439) presented at the 18th Annual Congress of the European League Against Rheumatism
    • 17 Jun 2017 Results of a pooled analysis from OPAL Broaden and OPAL Beyond trials presented at the 18th Annual Congress of the European League Against Rheumatism
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