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Could a stronger dose of an MS drug keep disability at bay?

NCT ID NCT04544436

Disease control Sponsor: Hoffmann-La Roche Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jul 31, 2026 · Updated 2 times

Summary

This study tests whether a higher dose of the drug ocrelizumab can better control relapsing multiple sclerosis (MS) and delay disability compared to the standard dose. About 864 adults with relapsing MS will receive either the higher or standard dose every 24 weeks. The main goal is to see if the higher dose slows worsening of walking, hand function, and overall disability.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

864 people

The number who actually took part.

Started

Nov 2020

Expected to finish

Aug 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 55 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Diagnosis of RMS * At least two documented clinical relapses within the last 2 years prior to screening, or one clinical relapse in the year prior to screening. No relapse 30 days prior to screening and at baseline * Participants must be neurologically stable for at least 30 days prior to randomization and baseline * EDSS score, at screening and baseline, from 0 to 5.5 inclusive * Average T25FWT score over two trials at screening and over two trials at baseline respectively, up to 150 (inclusive) seconds * Average 9HPT score over four trials at screening and over four trials at baseline respectively, up to 250 (inclusive) seconds * Documented magnetic resonance imaging (MRI) of brain with abnormalities consistent with MS at screening * Participants requiring symptomatic treatment for MS and/or physiotherapy must be treated at a stable dose. No initiation of symptomatic treatment for MS or physiotherapy within 4 weeks of randomization * Females of childbearing potential, agreement to remain abstinent or use adequate contraceptive methods * Female participants without reproductive potential may be enrolled e.g. if post-menopausal or if surgically sterile Exclusion Criteria: * History of primary progressive MS at screening * Any known or suspected active infection at screening or baseline (except nailbed infections), or any major episode of infection requiring hospitalization or treatment with IV antimicrobials within 8 weeks or treatment with oral antimicrobials within 2 weeks, prior to and during screening * History of confirmed or suspected progressive multifocal leukoencephalopathy * History of cancer, including hematologic malignancy and solid tumors, within 10 years of screening * Immunocompromised state * Receipt of a live or live-attenuated vaccine within 6 weeks prior to randomization * Inability to complete an MRI or contraindication to gadolinium administration * Contraindications to mandatory pre-medications for infusion-related reaction (IRRs) * Known presence of other neurologic disorders that could interfere with the diagnosis of MS or assessments of efficacy and/or safety during the study * Any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study * Significant, uncontrolled disease that may preclude participant from participating in the study * History of or currently active primary or secondary, non-drug-related, immunodeficiency * Pregnant or breastfeeding or intending to become pregnant * Lack of peripheral venous access * History of alcohol or other drug abuse within 12 months prior to screening * Treatment with any investigational agent within 24 weeks prior to screening or treatment with any experimental procedure for MS * Previous use of anti- cluster of differentiation 20 (CD20s) (including ocrelizumab), unless the last infusion was more than 2 years before screening, B-cell count is normal, and the stop of the treatment was not motivated by safety reasons or lack of efficacy * Previous treatment with fingolimod, siponimod, or ozanimod within 6 weeks of baseline * Previous treatment with natalizumab within 4.5 months of baseline * Previous treatment with interferons beta (1a or 1b), or glatiramer acetate within 2 weeks of baseline * Any previous treatment with mitoxantrone, cladribine, atacicept, alemtuzumab, and daclizumab - Previous treatment with any other immunomodulatory or immunosuppressive medication not already listed above without appropriate washout as described in the applicable local label. If the washout requirements are not described in the applicable local label, then the wash out period must be five times the half-life of the medication * Any previous treatment with bone marrow transplantation and hematopoietic stem cell transplantation * Any previous history of transplantation or anti-rejection therapy * Treatment with IV immunoglobulin (Ig) or plasmapheresis within 12 weeks prior to randomization * Systemic corticosteroid therapy within 4 weeks prior to screening * Positive screening tests for active, latent, or inadequately treated hepatitis B * Sensitivity or intolerance to any ingredient (including excipients) of ocrelizumab * Any additional exclusionary criterion as per ocrelizumab local label, if more stringent than the above

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Conditions

The condition(s) this trial relates to.

multiple sclerosis relapsing-remitting multiple sclerosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Multiple sclerosis

Contacts and locations

Locations

  • 21st Century Neurology

    Phoenix, Arizona, 85004, United States

  • 401 Military Hospital of Athens

    Athens, 11525, Greece

  • 5th Cherkasy City Center of Primary Health Care

    Cherkasy, 18029, Ukraine

  • AOU Seconda Università degli Studi

    Naples, Campania, 80131, Italy

  • AOU Seconda Università degli Studi

    Naples, Campania, 80138, Italy

  • Abington Neurological Associates

    Willow Grove, Pennsylvania, 19090, United States

  • Advanced Neurology of Colorado, LLC

    Fort Collins, Colorado, 80528, United States

  • Alabama Neurology Associates

    Homewood, Alabama, 35209, United States

  • American Health Network Institute, LLC

    Avon, Indiana, 46123, United States

  • Austin Hospital

    Heidelberg, Victoria, 3084, Australia

  • Bhupesh Dihenia M.D. P.A.

    Lubbock, Texas, 79410, United States

  • Bukovinsky SMU RMI Chernivtsi RCH

    Chernivtsi, 58002, Ukraine

  • CEMIC

    Buenos Aires, C1431FWO, Argentina

  • CH St Vincent de Paul

    Lille, 59000, France

  • CHU Hopital Gabriel Montpied

    Clermont-Ferrand, 63003, France

  • COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika

    Gdansk, 80-803, Poland

  • CPQuali Pesquisa Clinica Ltda

    São Paulo, São Paulo, 01228-000, Brazil

  • Centre de Recherche Saint-Louis

    Lévis, Quebec, G6W 0M5, Canada

  • Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz

    Lisbon, 1349-019, Portugal

  • Centro de Especialidades Neurológicas y Rehabilitación - CENyR

    Buenos Aires, C1424, Argentina

  • Centro de Investigaciones Médicas Tucuman

    San Miguel de Tucumán, T4000AXL, Argentina

  • Centrum Medyczne NeuroProtect

    Warsaw, 01-684, Poland

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324, Poland

  • Charite - Universitätsmedizin Berlin

    Berlin, 12203, Germany

  • City Clinical Hospital #24

    Moskva, Moscow Oblast, 127015, Russia

  • City Hospital #40 of Kurortniy Administrative District

    Saint Petersburg, Sankt-Peterburg, 197706, Russia

  • Cleveland Clinic Lou Ruvo

    Las Vegas, Nevada, 89106, United States

  • Clinica Internacional

    Lima, 15001, Peru

  • Clinica Neurologica

    Joinville, Santa Catarina, 89201-165, Brazil

  • Clinica Sanchez Ferrer

    Trujillo, Lima 13009, Peru

  • Complejo Hospitalario Universitario A Coruña (CHUAC)

    A Coruña, LA Coruna, 15006, Spain

  • Dent Neurological Institute

    Amherst, New York, 14226, United States

  • Derriford Hospital

    Plymouth, PL6 8DH, United Kingdom

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191, Germany

  • Dragonfly Research, LLC

    Wellesley, Massachusetts, 02481, United States

  • EMC Instytut Medyczny SA

    Późna, 60-309, Poland

  • Evergreen MS Center

    Kirkland, Washington, 98034, United States

  • FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency

    Krasnoyarsk, Krasnoyarsk Krai, 660037, Russia

  • Federal center of brain research and neurotechnologies

    Moskva, Moscow Oblast, 117997, Russia

  • Fond. Istituto Neurologico C.Besta

    Milan, Lombardy, 20133, Italy

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • Henry Ford Health System

    Detroit, Michigan, 48202, United States

  • Hope Neurology

    Knoxville, Tennessee, 37922, United States

  • Hospital Alvaro Cunqueiro

    Vigo, Pontevedra, Spain

  • Hospital Erasme

    Brussels, 1070, Belgium

  • Hospital IV Alberto Sabogal Sologuren

    Bellavista, Callao 2, Peru

  • Hospital Maria Auxiliadora

    Lima, Lima 29, Peru

  • Hospital Nacional Dos de Mayo

    Lima, Peru

  • Hospital Puerta del Mar

    Cadiz, 11009, Spain

  • Hospital Quiron de Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Regional Universitario de Malaga ? Hospital General

    Málaga, 29010, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital de Braga

    Braga, 4710-243, Portugal

  • Hospital de Santa Maria

    Lisbon, 1649-035, Portugal

  • Hôpital Charles Nicolle

    Rouen, 76031, France

  • IMV Pesquisa Neurológica

    Porto Alegre, Rio Grande do Sul, 90620-130, Brazil

  • IRCCS Istituto Neurologico Neuromed

    Pozzilli, Molise, 86077, Italy

  • Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak.

    Lublin, 20-410, Poland

  • Inselspital Bern Medizin Neurologie

    Bern, 3010, Switzerland

  • Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo

    Lima, Lima 01, Peru

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310, Brazil

  • Instytut Psychiatrii i Neurologii II Klinika Neurologiczna

    Warsaw, 02-957, Poland

  • KSMU Interregional Clinical Diagnostic Centre

    Kazan', Tatarstan Republic, 420101, Russia

  • Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie

    Warsaw, 02-097, Poland

  • Kocaeli University Hospital

    Kocaeli, 41380, Turkey (Türkiye)

  • LCC "Medical center "Unimed"

    Zaporizhzhya, 69035, Ukraine

  • Lone Star Neurology of San Antonio

    San Antonio, Texas, 78258, United States

  • Lvivska oblasna tsentralna likarnia

    Lviv, 79010, Ukraine

  • MA-LEK Clinical Sp. Z o.o.

    Katowice, 40-571, Poland

  • Maine Medical Center

    Scarborough, Maine, 04074, United States

  • Medical Center Dopomoga Plus

    Kyiv, 03143, Ukraine

  • Medical Center of Private Execution First Private Clinic

    Kyiv, 03037, Ukraine

  • Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?

    Chernihiv, 14029, Ukraine

  • Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council

    Zaporizhzhya, 69600, Ukraine

  • Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital

    Kharkiv, 61058, Ukraine

  • N.P. Bechtereva Institute of the Human Brain

    Saint Petersburg, Sankt-Peterburg, 197376, Russia

  • NCL Institute Neuroscience

    Rome, Lazio, 00178, Italy

  • National Center of Social Significant Disease

    Saint Petersburg, Sankt-Peterburg, 197110, Russia

  • Nebbiolo Center for Clinical Trials

    Tomsk, 634009, Russia

  • Neiro Clinica LLC

    Moscow, Moscow Oblast, 117186, Russia

  • Neurocentrum Bydgoszcz sp. z o.o

    Bydgoszcz, 85-796, Poland

  • Neurology Associates, PA

    Maitland, Florida, 32751, United States

  • Nmedis sp. z o.o.

    Rzeszów, 35-323, Poland

  • North Central Neurology Associates

    Cullman, Alabama, 35058, United States

  • Oklahoma Medical Research Foundation

    Oklahoma City, Oklahoma, 73104, United States

  • Ospedale Regionale di Lugano - Civico

    Lugano, 6903, Switzerland

  • Osrodek Badan Klinicznych Euromedis

    Szczecin, 70-215, Poland

  • Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla

    Rome, Lazio, 00133, Italy

  • Policlinico Umberto I

    Rome, Lazio, 00185, Italy

  • Profound Research, LLC

    Carlsbad, California, 92011, United States

  • Recherche Sepmus Inc.

    Greenfield Park, Quebec, J4V 2J2, Canada

  • Regional Clinical Hospital

    Ivano-Frankivsk, 76008, Ukraine

  • Research Center of Neurology of RAMS

    Moscow, Moscow Oblast, 125367, Russia

  • Revalidatie en MS Centrum

    Overpelt, 3900, Belgium

  • Rigshospitalet Glostrup

    Glostrup Municipality, 2600, Denmark

  • S-Medicon Egeszsegugyi Szolgaltato Kft.

    Budapest, 1138, Hungary

  • SHI Sverdlovsk Regional Clinical Hospital #1

    Yekaterinburg, Sverdlovsk Oblast, 620102, Russia

  • SI USSRI of Medical and Social Problems of Disabilities of MOHU

    Dnipro, 49027, Ukraine

  • SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM

    Lodz, 90-153, Poland

  • Saratov State Medical University of RosZdrav

    Saratov, 410012, Russia

  • Somogy Vármegyei Kaposi Mór Oktató Kórház

    Kaposvár, 7400, Hungary

  • St. Josef-Hospital, Klinik für Neurologie

    Bochum, 44791, Germany

  • St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU

    Kharkiv, 61068, Ukraine

  • Stanford University Medical Center

    Stanford, California, 94305, United States

  • The NeuroMedical Clinic of Central Louisiana

    Alexandria, Louisiana, 71301, United States

  • Tri-State Mountain Neurology

    Johnson City, Tennessee, 37604, United States

  • UC Health Neurology

    Dayton, Ohio, 45417, United States

  • UNO Medical Trials Kft.

    Budapest, 1152, Hungary

  • Ulyanovsk Regional Clinical Hospital

    Ulyanovsk, Ulyanovsk Oblast, 432063, Russia

  • Universita? G. D'Annunzio

    Chieti, Abruzzo, 66100, Italy

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Universität Leipzig

    Leipzig, 04103, Germany

  • Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

    Dresden, 01307, Germany

  • Universitätsklinikum Schleswig-Holstein

    Kiel, 24105, Germany

  • Universitätsklinikum Ulm

    Ulm, 89081, Germany

  • Universitätsspital Basel Medizin Neurologie

    Basel, 4031, Switzerland

  • Vertebronevrologiya LLC

    Kazan', Tatarstan Republic, 420047, Russia

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy

    Warsaw, 04-141, Poland

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