This is an Extension Study of the Roche P-trial to Investigate Safety and Effectiveness of a Single Ocrelizumab Dose in Participants With Multiple Sclerosis (MS)

  • Multiple Sclerosis (MS)
Trial Status:

Recruiting

This trial runs in
Countries
  • Argentina
  • Belgium
  • Brazil
  • Bulgaria
  • Canada
  • Croatia
  • Denmark
  • France
  • Hungary
  • Italy
  • Kuwait
  • Mexico
  • Netherlands
  • Norway
  • Poland
  • Portugal
  • Slovakia
  • Slovenia
  • Spain
  • Sweden
  • Turkey
  • United Kingdom
Trial Identifier:

NCT03599245 2017-004886-29 MN39158

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      The source of the below information is the publicly available website ClinicalTrials.gov. It has been summarised and edited into simpler language.

      The below information is taken directly from the publicly available website ClinicalTrials.gov within a week of any updates, and has not been edited.

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      Trial Summary

      This extension study will evaluate the effectiveness and safety of ocrelizumab in multiple sclerosis (MS) participants who were previously enrolled in a F. Hoffmann-La Roche (Roche) sponsored ocrelizumab phase IIIb/IV trial (i.e. the Parent, P-trial).

      Hoffmann-La Roche Sponsor
      Phase 3 Phase
      NCT03599245 , MN39158 , 2017-004886-29 Trial Identifier
      Ocrelizumab Treatments
      Multiple Sclerosis Condition
      Official Title

      A Single Arm, Open Label Multicentre Extension Study To Evaluate The Effectiveness And Safety Of Ocrelizumab In Patients With Multiple Sclerosis Previously Enrolled In A F. Hoffmann-La Roche Sponsored Ocrelizumab Phase IIIb/IV Clinical Trials

      Eligibility Criteria

      All Gender
      ≥ 18 Years & ≤ 65 Years Age
      No Healthy Volunteers
      Inclusion Criteria
      • Signed Informed Consent Form
      • Able to comply with the study protocol, in the investigator's judgment
      • Completed the treatment period of Roche sponsored ocrelizumab P-trials
      Exclusion Criteria
      • Hypersensitivity to ocrelizumab or to any of its excipients.
      • Participantss in a severely immunocompromised state until the condition resolves.
      • Evidence of any adverse event potentially attributable to ocrelizumab, for which the local label recommends permanent discontinuation.
      • Existence of a contra-indication as per SmPC
      • Prohibited concomitant medication as specified in protocol
      • Participants intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study

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