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: 11 Dec 2017

At a glance

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

    • 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.
    • 10 Nov 2017 According to a Roche media release, based on the data from this and other two studies (700204506and 700191566), company gained the postitive opinion from the Committee for Medicinal Products for Human Use (CHMP).
    • 28 Oct 2017 Results assessing effects of ocrelizumab on upper limb function, presented at the 7th Joint Congress of the European Committee for Treatment and Research in Multiple Sclerosis and Americas Committee for Treatment and Research in Multiple Sclerosis.
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