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: 08 Nov 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

    • 08 Nov 2017 Results of post hoc analysis identifying baseline factors that predict response to abatacept treatment in patients with PsA in ASTRAEA presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 08 Nov 2017 Results (n=422) of post hoc analysis assessing the relationship between body mass index and abatacept response presented at the 81st American College of Rheumatology and the 52nd Association of Rheumatology Health Professionals Annual Scientific Meeting
    • 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.
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