A Study to Evaluate the Effectiveness and Safety of Ocrelizumab in Patients with Multiple Sclerosis Previously Enrolled in A F. Hoffmann-la Roche Sponsored Ocrelizumab Clinical Trial

Phase 1

Conditions: Multiple sclerosis (MS)
MedDRA version: 20.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0Level: PTClassification code 10048393Term: Multiple sclerosis relapseSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1Level: PTClassification code 10063399Term: Relapsing-remitting multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.1Level: LLTClassification code 10039720Term: Sclerosis multipleSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2017-004886-29-DK

Lead Sponsor: F. Hoffmann-La Roche Ltd

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 659

Inclusion Criteria

- Able to comply with the study protocol, in the investigator’s judgment
- Eligible for roll-over into the MN39158/LIBERTO study (including the female patients who were pregnant during the parent studies and are still in the safety follow up period) based on the investigator decision in a Roche sponsored ocrelizumab P-trial upon risk/benefit assessment for continuous treatment with ocrelizumab
- Meet re-treatment criteria with ocrelizumab
- Patients who became pregnant by chance between the last visit of the parent study and screening of this study, as confirmed by pregnancy tests at screening, will enter the safety follow-up immediately and re-start the treatment after birth and breastfeeding are over, as per re-treatment criteria
- For women of childbearing potential: agreement to remain abstinent or use an acceptable birth control method during the treatment period and for at least 6 months or longer after the final dose of ocrelizumab, as applicable in the local ocrelizumab package leaflet.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 659
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Hypersensitivity to ocrelizumab or to any of its excipients
- Patients 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 ocrelizumab package leaflet
- Prohibited concomitant medication use
- Patients intending to become pregnant during the study or within 6 months after the last dose of the study drug in the parent study
- Patients who discontinued ocrelizumab, exemption made for treatment discontinuation due to unplanned pregnancy and breastfeeding for patients who continued clinical study assessments in the safety follow-up of the parent study

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: • To evaluate the effectiveness of ocrelizumab therapy in MS patients who were previously enrolled in a Roche sponsored phase IIIb/IV-trial;Secondary Objective: • Different effectiveness measures evaluated for ocrelizumab in MS patients who were previously enrolled in a Roche sponsored phase IIIb/IV-trial<br>• To evaluate the safety and tolerability of ocrelizumab therapy in MS patients who were previously enrolled in a Roche sponsored phase IIIb/IV-trial<br>;Primary end point(s): 1. Evaluate clinical measures related to disease progression over the duration of treatment in MS patients;Timepoint(s) of evaluation of this end point: 1. Up to 2 years

Secondary Outcome Measures

Name	Time	Method

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