A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis.

Trial Profile

A Phase 3 Randomized Placebo-Controlled Study to Evaluate the Efficacy and Safety of Abatacept Subcutaneous Injection in Adults With Active Psoriatic Arthritis.

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 27 Sep 2017

At a glance

  • Drugs Abatacept (Primary)
  • Indications Psoriatic arthritis
  • Focus Registrational; Therapeutic Use
  • Acronyms ASTRAEA; PsA-II
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 26 Jul 2017 According to a Bristol-Myers Squibb media release, the European Commission (EC) has approved ORENCIA alone or in combination with methotrexate for the treatment of active PsA in adult patients for whom the response to previous disease-modifying antirheumatic drug (DMARD) therapy, including methotrexate, has been inadequate, and additional systemic therapy for psoriatic skin lesions is not required. The approval was based on PsA-I and PsA-II studies.
    • 10 Jul 2017 Planned End Date changed from 1 Jul 2017 to 6 Jul 2020.
    • 06 Jul 2017 According to a Bristol-Myers Squibb media release, the U.S. Food and Drug Administration (FDA) has approved ORENCIA for the treatment of adults with active Psoriatic Arthritis.
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