An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
Recruiting now · Phase 3
Conditions studied: Multiple Sclerosis
In brief
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.
Key facts
- Study ID
- NCT06675955
- Run by
- Hoffmann-La Roche
- People needed
- 500
- Starts
- 2024-12-13
- Expected to finish
- 2029-12-31
- Last updated by the study team
- 2026-02-18
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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 is running
- Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council — Zaporizhzhya, Ukraine (enrolling)
- CHU de Besancon Hopital Jean Minjoz — Besançon, France (enrolling)
- Groupe Hospitalier Pellegrin — Bordeaux, France (enrolling)
- CHU Brest Hopital La Cavale Blanche — Brest, France (enrolling)
- Hopital neurologique Pierre Wertheimer - CHU Lyon — Bron, France (enrolling)
- CHU De Caen — Caen, France (enrolling)
- CHU Amiens Hopital Sud — Amiens Cedex1, France (enrolling)
- CH St Vincent de Paul — Lille, France (enrolling)
- Hopital Gui de Chauliac — Montpellier, France (enrolling)
- Hopital Nord Laennec — Nantes, France (enrolling)
- Hôpital Pasteur — Nice, France (enrolling)
- GroupeHospitalo-Universitaire Caremeau — Nîmes, France (enrolling)
- Hopital de Hautepierre — Strasbourg, France (enrolling)
- NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH — Ulm, Germany (enrolling)
- Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz — Westerstede, Germany (enrolling)
- Deutsche Klinik für Diagnostik — Wiesbaden, Germany (enrolling)
- Krasnoyarsk State Medical Academy — Krasnoyarsk, Krasnoyarsk Krai, Russia (enrolling)
- FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency — Krasnoyarsk, Krasnoyarsk Krai, Russia (enrolling)
- City Clinical Hospital #24 — Moscow, Moscow Oblast, Russia (enrolling)
- Federal center of brain research and neurotechnologies — Moskva, Moscow Oblast, Russia (enrolling)
- National Center of Social Significant Disease — Saint Petersburg, Sankt-Peterburg, Russia (enrolling)
- LLC Osnova — Saint Petersburg, Sankt-Peterburg, Russia (enrolling)
- N.P. Bechtereva Institute of the Human Brain — Saint Petersburg, Sankt-Peterburg, Russia (enrolling)
- City Hospital #40 of Kurortniy Administrative District — Saint Petersburg, Sankt-Peterburg, Russia (enrolling)
- SHI Sverdlovsk Regional Clinical Hospital #1 — Yekaterinburg, Sverdlovsk Oblast, Russia (enrolling)
Full record on ClinicalTrials.gov
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