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An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

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Trial Profile

An Open-Label, Single-Arm Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients With Early Stage Relapsing Remitting Multiple Sclerosis

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Dec 2024

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At a glance

  • Drugs Ocrelizumab (Primary)
  • Indications Multiple sclerosis
  • Focus Adverse reactions; Registrational; Therapeutic Use
  • Acronyms ENSEMBLE
  • Sponsors Roche; Roche Farma

    • Most Recent Events

    • 18 Apr 2024 Results assessing of 4-year efficacy and safety data of ocrelizumab in a subgroup of patients with early, high-activity relapsing-remitting multiple sclerosis (HA RRMS) from this study and to assess predictors of no evidence of disease activity (NEDA)-3 in the overall ENSEMBLE population was presented at the 76th Annual Meeting of the American Academy of Neurology 2024.
    • 18 Apr 2024 Results (n=301) assessing ocrelizumab effectiveness in early-stage relapsing-remitting multiple sclerosis presented at the 76th Annual Meeting of the American Academy of Neurology 2024
    • 10 Mar 2024 This trial has been completed in Portugal, according to the European Clinical Trials Database record.

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