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A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis.

Trial Profile

A Randomized, Multicenter, Double-Blind, Placebo-Controlled, Dose-Comparison Study to Determine the Efficacy and Safety of BG00012 in Subjects With Relapsing-Remitting Multiple Sclerosis.

Completed
Phase of Trial: Phase III

Latest Information Update: 12 Oct 2018

At a glance

  • Drugs Dimethyl fumarate (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms DEFINE
  • Sponsors Biogen; Biogen Idec
  • Most Recent Events

    • 12 Oct 2018 Results of integrated analysis of the DEFINE,CONFIRM and extension ENDORSE studies examining the clinical implications of dimethyl fumarate (DMF) associated lymphopenia and post-treatment absolute lymphocyte count (ALC) dynamics presented at the 34th Congress of the European Committee for Treatment and Research in Multiple Sclerosis.
    • 19 Jun 2018 Results assessing cost effectiveness by taking data from CONFIRM and DEFINE studies, presented at the 4th Congress of the European Academy of Neurology.
    • 01 Dec 2017 Results of pooled post-hoc integrated analysis of DEFINE and CONFIRM trials assessing efficacy and tolerability, published in the Neurology and Therapy
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