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A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

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Trial Profile

A Study To Investigate The Pharmacokinetics, Pharmacodynamics, Safety And Radiological And Clinical Effects Of Subcutaneous Ocrelizumab Versus Intravenous Ocrelizumab In Patients With Multiple Sclerosis

Status: Active, no longer recruiting
Phase of Trial: Phase III

Latest Information Update: 01 Jul 2024

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At a glance

  • Drugs Ocrelizumab (Primary) ; Ocrelizumab (Primary) ; Desloratadine; Dexamethasone; Diphenhydramine; Methylprednisolone
  • Indications Multiple sclerosis
  • Focus Pharmacokinetics; Registrational
  • Acronyms Ocarina II
  • Sponsors Roche; Roche Farma
  • Most Recent Events

    • 25 Jun 2024 According to a Roche media release, company announced that Roche received European Commission (EC) marketing authorization of OCREVUS with ENHANZE for the treatment of relapsing multiple sclerosis and primary progressive multiple sclerosis on basis of this trial.
    • 29 Apr 2024 According to a Roche media release, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) has recommended the approval of Ocrevus (ocrelizumab) subcutaneous (SC) for its multiple sclerosis (MS) indications. A final decision on its approval from the European Commission is expected mid-2024.This opinion is based on pivotal data from this study.
    • 18 Apr 2024 Results of non inferiority to IV 600mg with respect to AUCWa12 and similar clinical and imaging measures presented at the 76th Annual Meeting of the American Academy of Neurology 2024
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