RecruitingPhase 3NCT06675955

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


Sponsor

Hoffmann-La Roche

Enrollment

500 participants

Start Date

Dec 13, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This is a follow-up (extension) study for people with multiple sclerosis (MS) who are already receiving ocrelizumab — a medication given by infusion that reduces immune attacks on the nervous system. The goal is to continue monitoring physical function over time and ensure participants keep receiving their treatment. **You may be eligible if...** - You are currently enrolled in one of the qualifying parent MS studies (such as CONSONANCE, MUSETTE, GAVOTTE, or related trials) - You are already receiving ocrelizumab as part of your current MS treatment - You agree to continue following the study's schedule and assessments **You may NOT be eligible if...** - You are not currently part of one of the specified parent studies - You have stopped receiving ocrelizumab for reasons other than temporary holds - You are not willing or able to continue attending study visits Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGOcrelizumab

Ocrelizumab will be administered at the approved dose of 600 mg, IV infusion or 920 mg, SC injection, according to the regimen in the parent study.


Locations(44)

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

Hopital Nord Laennec

Nantes, 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

National Center of Social Significant Disease

Saint Petersburg, Sankt-Peterburg, 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

Volyn Regional Clinical Hospital

Lutsk, 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

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NCT06675955


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