An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment

Launched by HOFFMANN-LA ROCHE · Nov 4, 2024

Keywords

ClinConnect Summary

This clinical trial is an extension study for people with Multiple Sclerosis (MS) who are currently receiving treatment with a medication called ocrelizumab. The main goals of this study are to understand how MS affects physical abilities from the participants' viewpoint, continue providing access to ocrelizumab for those who need it, and evaluate how safe and well-tolerated the treatment is over time.

To be eligible for this trial, participants should be between the ages of 65 and 74 and must have been treated with ocrelizumab in earlier studies but do not have easy access to it now. Participants will receive their first dose of the study treatment at least five months after their last dose from the previous study. It’s important to note that those who have access to ocrelizumab in their country or who have certain health conditions may not qualify for this trial. Participants can expect regular check-ins and assessments to monitor their health and the effects of the treatment throughout the study.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Participants who were on ongoing ocrelizumab treatment on one of the following parent-studies \[Studies MN39159/CONSONANCE (NCT03523858), BN42082/MUSETTE (NCT04544436), BN42083/GAVOTTE (NCT04548999), BN44083/GLOBEAM, MN43978/CONSONANCE Ext., WA40404/O'HAND (NCT04035005), MN43964/OLERO (NCT05269004), GN41791/FENTREPID (NCT04544449), BP46016/MINTAKA, CN41144/OCARINA I-SC (NCT03972306), CN42097/OCARINA II-SC (NCT05232825)\] 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 participants 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 premature 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.