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Assessing the impact of Multiple Sclerosis on physical function while providing continued ocrelizumab treatment

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

Phase 3 Interventional Hoffmann-La Roche · NCT06675955

This study is testing how Multiple Sclerosis affects physical function while continuing treatment with the medication ocrelizumab for people who have already been part of related studies.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment500 (estimated)
Ages18 Years and up
SexAll
SponsorHoffmann-La Roche Industry-sponsored
Drugs / interventionsocrelizumab
Locations44 sites (Amiens Cedex1 and 43 other locations)
Trial IDNCT06675955 on ClinicalTrials.gov

What this trial studies

This study evaluates the physical impact of Multiple Sclerosis (MS) from the participants' perspective while providing ongoing access to the medication ocrelizumab. It aims to assess the safety and tolerability of ocrelizumab in patients who have previously participated in related studies. Participants will receive treatment after a specified period following their last dose in the parent studies, ensuring continuity of care for those without local access to the drug.

Who should consider this trial

Good fit: Ideal candidates are individuals with Multiple Sclerosis who have been receiving ocrelizumab treatment in prior studies and lack local access to the medication.

Not a fit: Patients who have access to commercially marketed ocrelizumab in their country may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could enhance the management of MS by providing continuous treatment options and improving patients' physical functioning.

How similar studies have performed: Other studies involving ocrelizumab have shown positive outcomes, indicating that this approach is supported by previous research.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

Amiens Cedex1 and 43 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Multiple SclerosisOcrelizumab
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.