An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Recruiting
Phase 3Interventional Study
Multiple Sclerosis
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
500 (estimated)
Sponsor
Hoffmann-La Roche · Industry
Who this trial is looking for
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Answer a few quick questions to see if you may meet the eligibility requirements.
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 6 onwards, treatment within this study will be limited to the currently approved doses of ocrelizumab, 600 milligrams (mg), intravenous (IV) infusion or 920 mg, subcutaneous (SC) injection.
Trial Locations
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Status
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), MN439…
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
Contacts
Reference Study ID Number: MN45053 https://forpatients.roche.com/
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