A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis.

Trial Profile

A Phase IIB, Multi-Dose, Multi-Center, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Versus Placebo in the Treatment of Psoriatic Arthritis.

Discontinued
Phase of Trial: Phase II

Latest Information Update: 23 Jan 2018

At a glance

  • Drugs Abatacept (Primary)
  • Indications Psoriatic arthritis
  • Focus Adverse reactions; Therapeutic Use
  • Acronyms PsA-I
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 23 Jan 2018 The Australian Therapeutic Goods Administration (TGA) has approved an additional indication for ORENCIA (abatacept) for the treatment of active Psoriatic Arthritis (PsA) in adults when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate. The approval was based on results from Studies PsA-I and PsA-II.
    • 04 Jul 2012 Planned number of patients changed from 170 to 220 as reported by European Clinical Trials Database.
    • 01 Apr 2011 Results published in the Arthritis and Rheumatism.
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