A Long-term, Open-label Extension Study Of Tofacitinib (Cp-690,550) For The Treatment Of Psoriatic Arthritis

Trial Profile

A Long-term, Open-label Extension Study Of Tofacitinib (Cp-690,550) For The Treatment Of Psoriatic Arthritis

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Aug 2017

At a glance

  • Drugs Tofacitinib (Primary)
  • Indications Psoriatic arthritis
  • Focus Adverse reactions; Registrational
  • Acronyms OPAL BALANCE
  • 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).
    • 26 Jul 2017 Status changed from recruiting to active, no longer recruiting.
    • 17 Jun 2017 Results (n=680) assessing safety and efficacy presented at the 18th Annual Congress of the European League Against Rheumatism.
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