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

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• MHAT Avis Medica OOD Department of Neurology
  Pleven, Bulgaria Recruiting
• UMHAT 'Dr. Georgi Stranski', EAD
  Pleven, Bulgaria Recruiting
• MHATNP Sveti Naum EAD
  Sofia, Bulgaria Recruiting
• CHU Amiens Hopital Sud
  Amiens Cedex1, France Recruiting
• CHIC Cote Basque Bayonne
  Bayonne, France Recruiting
• CHU de Besancon Hopital Jean Minjoz
  Besançon, France Recruiting

+6 more sites. See ClinicalTrials.gov for the full list.

Study contacts

• Study coordinator: Reference Study ID Number: MN45053 https://forpatients.roche.com/
• Email: global-roche-genentech-trials@gene.com
• Phone: 888-662-6728 (U.S. Only)

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• Comparing Rituximab and Ocrelizumab for Treating Relapsing Multiple Sclerosis

  This study is testing if rituximab works just as well as ocrelizumab for treating relapsing multiple sclerosis in adults.

  Recruiting Phase 3 Amsterdam UMC, location VUmc · Amsterdam · NCT05834855

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.