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A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

Trial Profile

A Randomized, Double-blind, Double-dummy, Parallel-group Study Comparing the Efficacy and Safety of Ofatumumab Versus Teriflunomide in Patients With Relapsing Multiple Sclerosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 28 Nov 2023

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At a glance

  • Drugs Ofatumumab (Primary) ; Teriflunomide
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms ASCLEPIOS I
  • Sponsors Novartis; Novartis Healthcare; Novartis Pharmaceuticals
  • Most Recent Events

    • 13 Oct 2023 Results assessing the effect of ofatumumab on serum IgG/IgM levels up to 5 years during the core and open-label extension studies (ASCLEPIOS I/II, APOLITOS, APLIOS & ALITHIOS) 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.
    • 13 Oct 2023 Results of pooled analysis (from studies ASCLEPIOS I/II for OFAand from FREEDOMS I, II and TRANSFORMS for FIN) assessing Indirect Treatment Comparison Methodologies to Differentiate the Efficacy of Ofatumumab and Other High Efficacy Therapies versus Orally Administered Disease Modifying Therapies for Relapsing Multiple Sclerosispresented at the 9th Triennial joint meeting of Americas Committee for Treatment and Research in Multiple Sclerosis and the European Committee for Treatment and Research
    • 27 Apr 2023 Results from NCT02792218, NCT02792231 and NCT03650114, presented at the 75th Annual Meeting of the American Academy of Neurology 2023
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