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A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS

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Trial Profile

A PHASE III MULTICENTER, RANDOMIZED, DOUBLE-BLIND, DOUBLE-DUMMY STUDY TO EVALUATE SAFETY AND EFFICACY OF OCRELIZUMAB IN COMPARISON WITH FINGOLIMOD IN CHILDREN AND ADOLESCENTS WITH RELAPSING-REMITTING MULTIPLE SCLEROSIS

Status: Recruiting
Phase of Trial: Phase III

Latest Information Update: 03 Sep 2024

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At a glance

  • Drugs Ocrelizumab (Primary) ; Fingolimod
  • Indications Multiple sclerosis
  • Focus Registrational; Therapeutic Use
  • Acronyms Operetta 2
  • Sponsors Roche
  • Most Recent Events

    • 25 Apr 2024 Planned number of patients changed from 233 to 171.
    • 31 Oct 2023 Planned End Date changed from 5 Nov 2025 to 17 Sep 2029.
    • 14 Feb 2022 Planned End Date changed from 5 Nov 2029 to 5 Nov 2025.

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