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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: Discontinued
Phase of Trial: Phase III

Latest Information Update: 21 Jan 2025

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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

  • 15 Jan 2025 Status changed from completed to discontinued. ( The study was terminated earlier as the study sponsor collected sufficient data to perform all analyses as per pre-specified endpoints in the study protocol.)
  • 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

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