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

• Status: Recruiting
• Trial end date: 2027-07-17
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Ocrelizumab

Criteria

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