An Extension Study to Assess Impact of Multiple Sclerosis (MS) on Physical Function and Provide Continued Ocrelizumab Treatment
NCT ID: NCT06675955
Last Updated: 2025-12-31
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
500 participants
INTERVENTIONAL
2024-12-13
2029-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Ocrelizumab
Participants will receive ocrelizumab at the same dose and schedule as the parent study until access to the treatment becomes locally available, unacceptable safety concern, death or withdrawal of consent.
Ocrelizumab
Ocrelizumab will be administered according to the regimen in the parent study.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Ocrelizumab
Ocrelizumab will be administered according to the regimen in the parent study.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hoffmann-La Roche
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Amiens Hopital Sud
Amiens Cedex1, , France
CHU de Besancon Hopital Jean Minjoz
Besançon, , France
Groupe Hospitalier Pellegrin
Bordeaux, , France
CHU Brest Hopital La Cavale Blanche
Brest, , France
Hopital neurologique Pierre Wertheimer - CHU Lyon
Bron, , France
CHU De Caen
Caen, , France
Hopital Gabriel Montpied CHU de Clermont-Ferrand
Clermont-Ferrand, , France
CH St Vincent de Paul
Lille, , France
Hopital Gui de Chauliac
Montpellier, , France
Hôpital Pasteur
Nice, , France
GroupeHospitalo-Universitaire Caremeau
Nîmes, , France
Hopital de Hautepierre
Strasbourg, , France
NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
Ulm, , Germany
Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
Westerstede, , Germany
Deutsche Klinik für Diagnostik
Wiesbaden, , Germany
Krasnoyarsk State Medical Academy
Krasnoyarsk, Krasnoyarsk Krai, Russia
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency
Krasnoyarsk, Krasnoyarsk Krai, Russia
City Clinical Hospital #24
Moscow, Moscow Oblast, Russia
Federal center of brain research and neurotechnologies
Moskva, Moscow Oblast, Russia
LLC Osnova
Saint Petersburg, Sankt-Peterburg, Russia
N.P. Bechtereva Institute of the Human Brain
Saint Petersburg, Sankt-Peterburg, Russia
City Hospital #40 of Kurortniy Administrative District
Saint Petersburg, Sankt-Peterburg, Russia
SHI Sverdlovsk Regional Clinical Hospital #1
Yekaterinburg, Sverdlovsk Oblast, Russia
Vertebronevrologiya LLC
Kazan', Tatarstan Republic, Russia
Ulyanovsk Regional Clinical Hospital
Ulyanovsk, Ulyanovsk Oblast, Russia
Center of Cardiology and Neurology
Kirov, , Russia
Regional clinical hospital named after prof. S.V. Ochapovsky
Krasnodar, , Russia
FSBIH Siberian Regional Medical Centre of FMBA of Russia
Novosibirsk, , Russia
Perm SMA n.a. academ. E.A. Vagner
Perm, , Russia
5th Cherkasy City Center of Primary Health Care
Cherkasy, , Ukraine
Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?
Chernihiv, , Ukraine
Bukovinsky SMU RMI Chernivtsi RCH
Chernivtsi, , Ukraine
SI USSRI of Medical and Social Problems of Disabilities of MOHU
Dnipro, , Ukraine
Regional Clinical Hospital
Ivano-Frankivsk, , Ukraine
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU
Kharkiv, , Ukraine
Medical Center Dopomoga Plus
Kyiv, , Ukraine
Medical Center of Private Execution First Private Clinic
Kyiv, , Ukraine
Lvivska oblasna tsentralna likarnia
Lviv, , Ukraine
Medical Clinical Research Center of Medical Center LLC Health Clinic
Vinnytsi, , Ukraine
LCC "Medical center "Unimed"
Zaporizhzhia, , Ukraine
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council
Zaporizhzhia, , Ukraine
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Reference Study ID Number: MN45053 https://forpatients.roche.com/
Role: CONTACT
Phone: 888-662-6728 (U.S. Only)
Email: [email protected]
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
2023-507633-21-01
Identifier Type: CTIS
Identifier Source: secondary_id
MN45053
Identifier Type: -
Identifier Source: org_study_id