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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: 12 Oct 2018

At a glance

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

    • 12 Oct 2018 Results of AFFIRM assessing the relationship overall response score (ORS) and and an established patient reported outcomes (PRO), presented at the 34th Congress of the European 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
    • 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
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