A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis

Trial Profile

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Determine the Safety and Efficacy of Natalizumab in Subjects With Relapsing-Remitting Multiple Sclerosis

Completed
Phase of Trial: Phase III

Latest Information Update: 15 Sep 2017

At a glance

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

    • 15 Sep 2017 Results assessing reversibility of natalizumab-mediated changes in pharmacokinetics/pharmacodynamics using patient data from AFFIRM and RESTORE trials published in the Neurology
    • 17 Sep 2016 Results of this and other four trials assessing relationship of natalizumab exposure and MRI response presented at the 32nd Congress of the European Committee for Treatment and Research in Multiple Sclerosis
    • 21 Apr 2016 Pooled subgroup analysis (n=3487) of 4 trials - AFFIRM, DEFINE, CONFIRM, and ADVANCE were presented at the 68th Annual Meeting of the American Academy of Neurology.
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