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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

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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

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 05 Oct 2023

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At a glance

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

    • 01 Oct 2023 Results from pooled analysis from NCT00027300, NCT00030966 associations association of age and inflammatory disease activity published in the Journal of Neurology, Neurosurgery and Psychiatry.
    • 01 Dec 2022 Results assessing the sensitivity and clinical meaningfulness of ODRS using natalizumab Phase 3 data sets -AFFIRM in relapsing-remitting MS and ASCEND in secondary progressive MS, published in the Multiple Sclerosis Journal
    • 26 Feb 2022 Results of an analysis assessed the gray and thalamic atrophy in patients with relapsing-remitting multiple sclerosis (RRMS) treated with natalizumab or placebo and to estimate the treatment effect of natalizumabpresented at the Americas Committee for Treatment and Research in Multiple Sclerosis Forum 2022

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