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Completed NCT03599245

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

Conditions: Multiple Sclerosis

Sex: All
Ages: 18 Years – 65 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 1055
Sponsor: Hoffmann-La Roche

Location: Hospital Churruca Visca Buenos Aires

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).

Eligibility 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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT03599245). StuddyBuddy aggregates publicly available trial information.