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-SI

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

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 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 <br>duration of treatment in MS patients<br>;Timepoint(s) of evaluation of this end point: 1. Up to 2 years

Secondary Outcome Measures

Name	Time	Method

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