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An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
- Autoimmune Disorder
- Multiple Sclerosis (MS)
Please note that the recruitment status of the study at your site may differ from the overall study status because some study sites may recruit earlier than others.
Study Status:
Recruiting
This study runs in
Cities
- Nice
- Nîmes
- Ulm
Trial Identifier:
NCT06675955 2023-507633-21-01 MN45053
Study Summary
The study will evaluate the physical impact of MS from participant's perspective, provide continued access to ocrelizumab and assess the safety and tolerability of ocrelizumab.
Hoffmann-La Roche
Sponsor
Phase 3
Phase
NCT06675955, MN45053, 2023-507633-21-01
Trial Identifier
Ocrelizumab
Treatments
Multiple Sclerosis
Condition
Official Title
An Open-Label, Multicenter Extension Study Evaluating the Patient Perspective of the Physical Impact of Multiple Sclerosis and Providing Continued Access to Ocrelizumab in Patients With Multiple Sclerosis Previously Enrolled in a Genentech and/or F. Hoffmann-La Roche Ltd Sponsored Study and Without Access to a Post-Trial Access Program
Eligibility Criteria
All
Gender
≥18 Years
Age
No
Healthy Volunteers
Inclusion Criteria
- Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies [Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)] at the time of roll-over and who do not have access to the ocrelizumab treatment locally.
- The first dose of study treatment in this extension study will be received no earlier than 5 months after the last treatment in the parent study.
- Negative urine pregnancy test within 24 hours to first dose administered on MN45053 study treatment in women of childbearing potential.
Exclusion Criteria
- Study treatment is commercially marketed in the participant's country for the participant specific disease and is reasonably accessible to the participant.
- Study treatment is available via Post Trial Access Program (PTAP) in the participant's country and is accessible to the participant.
- Permanent discontinuation of study treatment for any reason during the parent study or during the time between last treatment in the parent study and the first dose of study treatment in this extension study (if applicable).
- Any condition that, in the opinion of the investigator, would interfere with the interpretation of participant safety or place the participant at high risk for treatment-related complications.
- Concurrent participation in any therapeutic clinical trial (other than the parent study).
- Immunocompromised state
- Known active malignancy or are being actively monitored for recurrence of malignancy.
- Known presence of other neurological disorders.
For the latest version of this information please go to www.forpatients.roche.com