A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Trial Profile

A Phase III, Multicentre, Randomized, Parallel-group, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Ocrelizumab in Adults With Primary Progressive Multiple Sclerosis

Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 10 Apr 2018

At a glance

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

    • 15 Feb 2018 Results presented in a Roche media release.
    • 12 Jan 2018 According to a Roche media release, based on the data from ORATORIO, OPERA I and OPERA II trial the European Commission (EC) has granted marketing authorisation for OCREVUS (ocrelizumab) for patients with active relapsing forms of multiple sclerosis defined by clinical or imaging features and for patients with early primary progressive multiple sclerosis in terms of disease duration and level of disability, and with imaging features characteristic of inflammatory activity.
    • 10 Nov 2017 According to a Roche media release, final decision regarding approval of OCREVUS from the European Commission is expected in the coming months following which marketing authorisation for OCREVUS will be granted in all 28 member states of the European Union.
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