Status:
RECRUITING
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Lead Sponsor:
Hoffmann-La Roche
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief 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. From Protocol Version ...
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
Key Trial Info
Start Date :
December 13 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2029
Estimated Enrollment :
500 Patients enrolled
Trial Details
Trial ID
NCT06675955
Start Date
December 13 2024
End Date
December 31 2029
Last Update
February 18 2026
Active Locations (44)
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1
CHU Amiens Hopital Sud
Amiens Cedex1, France, 80054
2
CHU de Besancon Hopital Jean Minjoz
Besançon, France, 25030
3
Groupe Hospitalier Pellegrin
Bordeaux, France, 33076
4
CHU Brest Hopital La Cavale Blanche
Brest, France, 29609