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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

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-507633-21-01
Acronym
MN45053
Enrollment
136
Registered
2024-11-22
Start date
2024-12-09
Completion date
Unknown
Last updated
2025-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Brief summary

1. Change from baseline to end of study in Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a), 2. Number of eligible participants who have received access to ocrelizumab in the study (time frame: up to 5 years)

Detailed description

1. The incidence, nature, severity and outcome of serious adverse events, adverse events leading to discontinuation, and adverse events of special interest

Interventions

DRUGOcrevus 300 mg concentrate for solution for infusion

Sponsors

F. Hoffmann-La Roche AG
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
1. Change from baseline to end of study in Patient-Reported Outcome Measure Information System/Quality of Life in Neurological Disorders Physical Function Measure for Multiple Sclerosis 15a (PROMISnq PFMS-15a), 2. Number of eligible participants who have received access to ocrelizumab in the study (time frame: up to 5 years)

Secondary

MeasureTime frame
1. The incidence, nature, severity and outcome of serious adverse events, adverse events leading to discontinuation, and adverse events of special interest

Countries

Bulgaria, France, Germany

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026