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A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Trial Profile

A Phase 4, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Abatacept in Combination Therapy With Methotrexate vs. Methotrexate Alone in Subjects With Active Rheumatoid Arthritis and Inadequate Response to Methotrexate

Completed
Phase of Trial: Phase IV

Latest Information Update: 11 Mar 2019

At a glance

  • Drugs Abatacept (Primary) ; Methotrexate
  • Indications Rheumatoid arthritis
  • Focus Therapeutic Use
  • Sponsors Bristol-Myers Squibb
  • Most Recent Events

    • 11 Mar 2019 Primary endpoint (Change from baseline in Total Sharp Score (TSS) using the Modified van der Heijde Sharp (vdH-S) method to 6 months (Week 24)) has been met.
    • 11 Mar 2019 According to the Bristol-Myers Squibb media release, Bristol-Myers Squibb K.K. and ONO Pharmaceuticals has submitted supplemental applications of "Orencia for Intravenous Infusion 250mg", "Orencia 125mg Syringe for Subcutaneous Injection 1mL" and "Orencia 125mg Autoinjector for Subcutaneous Injection 1mL" for a partial change in approved items of the manufacturing and marketing approval in Japan.
    • 04 Jan 2017 Status changed from active, no longer recruiting to completed.
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