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A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

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Trial Profile

A Randomized, Controlled, Open-Label, Rater-Blinded, Phase 3b Study of the Efficacy, Safety, and Tolerability of 6-Week Extended Interval Dosing (EID) of Natalizumab (BG00002) in Subjects With Relapsing-Remitting Multiple Sclerosis Switching From Treatment With 4-Week Natalizumab Standard Interval Dosing (SID) in Relation to Continued SID Treatment - Followed by an Open-Label Crossover Extension Study Comprising Subcutaneous and Intravenous Natalizumab Administration

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 31 Jan 2024

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At a glance

  • Drugs Natalizumab (Primary) ; Natalizumab (Primary)
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms NOVA
  • Sponsors Biogen

    • Most Recent Events

    • 13 Oct 2023 Results (n=141) assessing patient preference for subcutaneous versus intravenous administration with natalizumab Q6W dosing 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
    • 17 Aug 2023 Status changed from active, no longer recruiting to completed.
    • 28 Feb 2023 Planned End Date changed from 15 Feb 2023 to 28 Jul 2023.
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