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