NCT06675955RecruitingPhase 3
An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide 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
Source: ClinicalTrials.gov · Last updated 28 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 500 (estimated)
- First submitted
- 4 Nov 2024
- Start date
- 13 Dec 2024
- Primary completion date
- 31 Dec 2029
- Lead sponsor
- Hoffmann-La Roche
- Diseases
- Multiple sclerosis
- NCT number
- NCT06675955
- EU CT number
- 2023-507633-21-01
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 500
- From 13 Dec 2024 to the primary completion date, 31 Dec 2029
- 57 sites in 6 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Concurrent participation in any therapeutic clinical trial (other than the parent study)
Other illness
- Study treatment is commercially marketed in the participant's country for the participant-specific disease and is reasonably accessible to the participant
- 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
- Known active malignancy or are being actively monitored for recurrence of malignancy
- Known presence of other neurological disorders
Other
- 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)
- Immunocompromised state
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (57)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Multiprofile Hospital For Active Treatment Avis Medika OOD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| University Multiprofile Hospital for Active Treatment Dr Georgi Stranski EAD Coordinator of this site? Confirm its status | Pleven | Bulgaria | Recruiting |
| Multiprofile Hospital For Active Treatment In Neurology And Psychiatry St. Naum EAD Coordinator of this site? Confirm its status | Sofia | Bulgaria | Recruiting |
| Military Medical Academy Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| University First multiprofile hospital for active treatment Sofia St. Joan Krastitel EAD Coordinator of this site? Confirm its status | Sofiya | Bulgaria | Recruiting |
| Gesundheit Nord gGmbH Klinikverbund Bremen Coordinator of this site? Confirm its status | Bremen | Germany | Recruiting |
| NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege GmbH Coordinator of this site? Confirm its status | Ulm | Germany | Recruiting |
| DKD HELIOS Klinik Wiesbaden GmbH Coordinator of this site? Confirm its status | Wiesbaden | Germany | Recruiting |
| Centre Hospitalier Universitaire Amiens - Picardie Coordinator of this site? Confirm its status | Amiens | France | Recruiting |
| Centre Hospitalier de la Cote Basque Coordinator of this site? Confirm its status | Bayonne | France | Recruiting |
| CHU Besancon Coordinator of this site? Confirm its status | Besancon Cedex | France | Recruiting |
| Centre hospitalier Universitaire de Bordeaux Coordinator of this site? Confirm its status | Bordeaux | France | Recruiting |
| Centre Hospitalier Régional et Universitaire de Brest Coordinator of this site? Confirm its status | Brest | France | Recruiting |
| Hospices Civils de Lyon Coordinator of this site? Confirm its status | Bron | France | Recruiting |
| Centre Hospitalier Universitaire De Caen Normandie Coordinator of this site? Confirm its status | Caen Cedex 9 | France | Recruiting |
| University Hospital Of Clermont-Ferrand Coordinator of this site? Confirm its status | Clermont Ferrand Cedex 1 | France | Recruiting |
| Groupement Des Hopitaux De L'Institut Catholique De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Lille Coordinator of this site? Confirm its status | Lille Cedex | France | Recruiting |
| Centre Hospitalier Universitaire De Montpellier Coordinator of this site? Confirm its status | Montpellier Cedex 5 | France | Recruiting |
| Centre Hospitalier Universitaire de Nice Coordinator of this site? Confirm its status | Nice | France | Recruiting |
| Centre Hospitalier Universitaire De Nimes Coordinator of this site? Confirm its status | Nimes Cedex 9 | France | Recruiting |
| Centre Hospitalier Intercommunal De Poissy Saint Germain Coordinator of this site? Confirm its status | Poissy | France | Recruiting |
| Centre Hospitalier Universitaire de Nantes Coordinator of this site? Confirm its status | Saint-Herblain | France | Recruiting |
| Les Hopitaux Universitaires De Strasbourg Coordinator of this site? Confirm its status | Strasbourg Cedex 2 | France | Recruiting |
| Hospital IV Alberto Sabogal Sologuren Coordinator of this site? Confirm its status | Bellavista | Peru | Recruiting |
| Hospital Nacional Guillermo Almenara Irigoyen Coordinator of this site? Confirm its status | La Victoria, Lima | Peru | Recruiting |
| Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo Coordinator of this site? Confirm its status | Lima | Peru | Recruiting |
| Hospital Nacional Dos de Mayo Coordinator of this site? Confirm its status | Lima | Peru | Recruiting |
| Vertebronevrologiya LLC Coordinator of this site? Confirm its status | Kazan' | Russia | Recruiting |
| Center of Cardiology and Neurology Coordinator of this site? Confirm its status | Kirov | Russia | Recruiting |
| Regional clinical hospital named after prof. S.V. Ochapovsky Coordinator of this site? Confirm its status | Krasnodar | Russia | Recruiting |
| FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency Coordinator of this site? Confirm its status | Krasnoyarsk | Russia | Recruiting |
| Krasnoyarsk State Medical Academy Coordinator of this site? Confirm its status | Krasnoyarsk | Russia | Recruiting |
| Research Center of Neurology of RAMS Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| City Clinical Hospital #24 Coordinator of this site? Confirm its status | Moscow | Russia | Recruiting |
| Federal center of brain research and neurotechnologies Coordinator of this site? Confirm its status | Moskva | Russia | Recruiting |
| FSBIH Siberian Regional Medical Centre of FMBA of Russia Coordinator of this site? Confirm its status | Novosibirsk | Russia | Recruiting |
| Perm SMA n.a. academ. E.A. Vagner Coordinator of this site? Confirm its status | Perm | Russia | Recruiting |
| N.P. Bechtereva Institute of the Human Brain Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| City Hospital #40 of Kurortniy Administrative District Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| LLC Osnova Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| SBIH City Clinical Hospital #31 Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Recruiting |
| Ulyanovsk Regional Clinical Hospital Coordinator of this site? Confirm its status | Ulyanovsk | Russia | Recruiting |
| SHI Sverdlovsk Regional Clinical Hospital #1 Coordinator of this site? Confirm its status | Yekaterinburg | Russia | Recruiting |
| 5th Cherkasy City Center of Primary Health Care Coordinator of this site? Confirm its status | Cherkasy | Ukraine | Recruiting |
| Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.? Coordinator of this site? Confirm its status | Chernihiv | Ukraine | Recruiting |
| Bukovinsky SMU RMI Chernivtsi RCH Coordinator of this site? Confirm its status | Chernivtsi | Ukraine | Recruiting |
| SI USSRI of Medical and Social Problems of Disabilities of MOHU Coordinator of this site? Confirm its status | Dnipro | Ukraine | Recruiting |
| Regional Clinical Hospital Coordinator of this site? Confirm its status | Ivano-Frankivsk | Ukraine | Recruiting |
| St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Recruiting |
| Medical Center Dopomoga Plus Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Medical Center of Private Execution First Private Clinic Coordinator of this site? Confirm its status | Kyiv | Ukraine | Recruiting |
| Volyn Regional Clinical Hospital Coordinator of this site? Confirm its status | Lutsk | Ukraine | Recruiting |
| Lvivska oblasna tsentralna likarnia Coordinator of this site? Confirm its status | Lviv | Ukraine | Recruiting |
| Medical Clinical Research Center of Medical Center LLC Health Clinic Coordinator of this site? Confirm its status | Vinnytsi | Ukraine | Recruiting |
| LCC "Medical center "Unimed" Coordinator of this site? Confirm its status | Zaporizhzhya | Ukraine | Recruiting |
| Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council Coordinator of this site? Confirm its status | Zaporizhzhya | Ukraine | Withdrawn |
This page is information, not medical advice. Discuss any trial with your doctor.