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

Roche

Status and phase

Active, not recruiting

Phase 3

Conditions

Multiple Sclerosis

Treatments

Drug: Ocrelizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT03599245

MN39158

2017-004886-29 (EudraCT Number)

Details and patient eligibility

About

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).

Full description

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.

Enrollment

1,500 estimated patients

Sex

All

Ages

18 to 65 years old

Volunteers

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