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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.

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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.

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 29 Nov 2023

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At a glance

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

    • Most Recent Events

    • 13 Oct 2023 Results assessing the effect of natalizumab on CGM and thalamic atrophy over 2 years (from MRI scans of NTZ-treated (n=94) patients from the STRIVE study) compared with a historical placebo in patients (n=63) with early relapsing remitting multiple sclerosis (from the dimethyl fumarate DEFINE trial), presented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research in Multiple Sclerosis.
    • 15 Apr 2023 Results post hoc pooled analysis from DEFINE, CONFIRM, and ENDORSE evaluating safety and efficacy of DMF in a subgroup of young adults aged 18-29 years, published in the Neurology and Therapy
    • 26 Apr 2022 Data from 3studies (ASCEND, DEFINE & CONFIRM) were used to predict treatment response with MRI-based sub-typing SuStaIn in relapsing and secondary progressive MS, presented at the 74th Annual Meeting of the American Academy of Neurology 2022.

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