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: 28 Oct 2017

At a glance

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

    • 28 Oct 2017 Results of pooled analysis of variability in adverse events reporting and discontinuation reasons from DEFINE and CONFIRM studies presented at the 7th Joint Congress of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis.
    • 28 Oct 2017 Results predicting MS disease progression in pooled sample from AFFIRM, DEFINE, CONFIRM and ADVANCE, presented at the 7th Joint Congress of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis
    • 28 Oct 2017 Results (Data cut of 1 October 2016; n=2513) of integrated analysis of DEFINE, CONFIRM, ENDORSE and NCT00168701 trials assessing the dynamics and clinical implications of on-DMF absolute lymphocyte count decline and post-DMF absolute lymphocyte count reconstitution presented at the 7th Joint Congress of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis
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