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

  • End date
    Mar 11, 2025
  • participants needed
  • sponsor
    Hoffmann-La Roche
Updated on 11 September 2023


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).


This is a single arm, open label, multicenter extension study in participants who completed treatment period with ocrelizumab in the Roche P-trials. Participants will receive treatment with ocrelizumab as single 600 mg infusions every 24 weeks for two years.

Condition Multiple Sclerosis
Treatment Ocrelizumab
Clinical Study IdentifierNCT03599245
SponsorHoffmann-La Roche
Last Modified on11 September 2023


Yes No Not Sure

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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What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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