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New hope for progressive MS: ocrelizumab trial targets disability

NCT ID NCT03523858

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jul 24, 2026 · Updated 3 times

Summary

This study is testing the drug ocrelizumab in 927 people with progressive multiple sclerosis (MS), a form of the disease that steadily worsens. Participants receive infusions every 24 weeks for about 4 years. The main goal is to see if the drug can stop or slow disability progression, measured by walking speed, hand function, and overall disability. Researchers are also tracking safety and cognitive changes.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
ocrelizumab
What this could lead to
If successful, this could confirm ocrelizumab as an effective long-term treatment to slow disability progression in progressive multiple sclerosis.
What could go wrong
This is an open-label, single-arm study with no placebo group, so results may be less reliable. Side effects from ocrelizumab include infusion reactions and increased infection risk.

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

927 people

The number who actually took part.

Started

May 2018

Expected to finish

Oct 2026

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 65 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: * Have a definite diagnosis of PMS (as per the revised McDonald 2010 criteria for PPMS or Lublin et al. 2014 criteria for PMS) * EDSS (Expanded Disability Status Scale) \</ =6.5 at screening * Have a documented evidence of disability progression independent of relapse at any point over the 2 years prior to the screening visit. In case relapse(s) have occurred in the last 2 years, disability progression will have to be considered as independent of relapse activity as per treating physician's judgment * Fulfill at least one of the 21 criteria assessing the evidence of disability progression independent of relapse activity in the last 2 years using the pre-baseline disability progression rating system checklist * Have experience of having used a smartphone and connecting a smartphone to Wi-Fi network providers * For women of childbearing potential: agreement to remain abstinent or use acceptable contraceptive methods during the treatment period and for at least 6 months, or longer if the local label is more stringent after the last dose of study drug Exclusion Criteria: * Relapsing-remitting multiple sclerosis (RRMS) at screening * Inability to complete an MRI * Gadolinium (Gd) intolerance * Known presence of other neurological disorders Exclusions Related to General Health: * Pregnancy confirmed by positive serum β human chorionic gonadotropin (hCG) measured at screening * Lactation * Any concomitant disease that may require chronic treatment of systemic corticosteroids or immunosuppressants during the course of the study * History or currently active primary or secondary immunodeficiency * Lack of peripheral venous access * Significant or uncontrolled somatic disease or any other significant disease that may preclude participant from participating in the study. * Active infections must be treated and resolved prior to the first infusion of ocrelizumab * Participants in a severely immunocompromised state until the condition resolves * Participants with known active malignancies or being actively monitored for recurrence of malignancy * Participants who have or have had confirmed progressive multifocal leukoencephalopathy (PML) Exclusions Related to Laboratory Findings: * Positive screening tests for hepatitis B * CD4 count \<250/μL * ANC \<1.0 × 103/μL * AST/SGOT or ALT/SGPT ≥3.0 × ULN in combination with either an elevated total bilirubin (\>2 X ULN) or clinical jaundice Exclusions Related to Medications: * Hypersensitivity to ocrelizumab or to any of its excipients * Previous treatment with ocrelizumab * Previous treatment with B-cell targeted therapies (i.e., atacicept, tabalumab, belimumab, ofatumumab, or obinutuzumab). Note: previous treatment with rituximab is allowed as long as the last dose was administered more than 6 months before the ocrelizumab infusion AND if discontinuation was due to adverse events or immunogenicity AND if Bcell levels are above the lower limit of normal (LLN) prior to screening. * Any previous treatment with alemtuzumab (Campath/Mabcampath/Lemtrada), total body irradiation, or bone marrow transplantation * Previous treatment with natalizumab where PML has not been excluded according to specific algorithm * Contraindications to or intolerance of oral or intravenous (IV) corticosteroids, including methylprednisolone administered IV, according to the country label * Systemic corticosteroid therapy within 4 weeks prior to screening * All vaccines should be given at least 6 weeks before the first infusion of ocrelizumab, unless the local regulations allow for a shorter interval. Live/live attenuated vaccines should be avoided during treatment and safety follow-up period until B cells are peripherally repleted * Previous treatment with daclizumab, ozanimod or figolimod in the last 8 weeks * Previous treatment with siponimod in the last 2 weeks * Treatment with fampridine/dalfampridine (Fampyra)/Ampyra) or other symptomatic MS treatment unless on stable dose for ≥30 days prior to screening * Previous treatment with natalizumab in the last 12 weeks. * Previous treatment with teriflunomide in the last 12 weeks. This washout period can be shortened if an accelerated elimination procedure is implemented before screening visit. One of the following elimination procedures can be used: * Cholestyramine 8 g administered 3 times daily for a period of at least 7 days (cholestyramine 4 g three times a day can be used, if cholestyramine 8 g three times a day is not well tolerated) * Alternatively, 50 g of activated powdered charcoal is administered every 12 hours for a period of at least 7 days. * Previous treatment with azathioprine, cyclophosphamide, mycophenolate mofetil or methotrexate in the last 12 weeks * Treatment with any investigational agent within 24 weeks of screening (Visit 1) or five half-lives of the investigational drug (whichever is longer) or treatment with any experimental procedures for MS * Previous treatment with mitoxantrone, cyclosporine or cladribine in the last 96 weeks * Participants previously treated with teriflunomide within the last two years, unless measured plasma concentrations are less than 0.02 mg/l. If above or not known, an accelerated elimination procedure should be implemented before screening visit

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Conditions

The condition(s) this trial relates to.

chronic progressive multiple sclerosis multiple sclerosis

As listed by the trial registrant

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

Progressive multiple sclerosis (PMS)

Contacts and locations

Locations

  • A. O. U. Federico II

    Naples, Campania, 80131, Italy

  • A.O. Sant'Andrea

    Rome, Lazio, 00189, Italy

  • AOU Città della Salute e della Scienza

    Turin, Piedmont, 10126, Italy

  • AOU Policlinico V. Emanuele - P.O G. Rodolico

    Catania, Sicily, 95123, Italy

  • AOUC Azienda Ospedaliero-Universitaria Careggi

    Florence, Tuscany, 50134, Italy

  • Aarhus Universitetshospital

    Aarhus N, 8200, Denmark

  • American University of Beirut - Medical Center

    Beirut, 11-236, Lebanon

  • Amphia Ziekenhuis

    Breda, 4818 CK, Netherlands

  • Azienda Ospedaliera Sant'Andrea

    Rome, Lazio, 00189, Italy

  • Azienda Ospedaliero Universitaria Consorziale Policlinico di

    Bari, Apulia, 70124, Italy

  • Azienda Sanitaria Ospedaliera S. Luigi Gonzaga

    Orbassano, Piedmont, 10043, Italy

  • Beaumont Hospital

    Dublin, 9, Ireland

  • CHIC Cote Basque Bayonne

    Bayonne, 64109, France

  • CHRU Nancy

    Nancy, 54035, France

  • CHU De Caen

    Caen, 14033, France

  • CHU de la Timone - Hopital d Adultes

    Marseille, 13005, France

  • Catharina ziekenhuis

    Eindhoven, 5623 EJ, Netherlands

  • Central Texas Neurology Consultants

    Round Rock, Texas, 78681, United States

  • Centre Hospitalier Universitaire Hassan II

    Fes, 30000, Morocco

  • Centre Hospitalier Universitaire de Rennes

    Rennes, 35033, France

  • Centrum Medyczne "MEDYK"

    Rzeszów, 35-055, Poland

  • Centrum Neurologii Krzysztof Selmaj

    Lodz, 90-324, Poland

  • City Clinical Hospital #24

    Moskva, Moscow Oblast, 127015, Russia

  • Cleveland Clinic Abu Dhabi

    Abu Dhabi, 112412, United Arab Emirates

  • Clinical Center University of Sarajevo

    Sarajevo, 71000, Bosnia and Herzegovina

  • Clinical Research Center-Alex university

    Alexandria, 21561, Egypt

  • Clinstile S.A de C.V.

    Mexico City, Mexico CITY (federal District), 06700, Mexico

  • Consultorios Médicos PaItilla

    Panama City, Panama

  • Cork University Hospital

    Cork, Ireland

  • Deutsche Klinik für Diagnostik

    Wiesbaden, 65191, Germany

  • Dragonfly Research, LLC

    Wellesley, Massachusetts, 02481, United States

  • Fakultni nemocnice Ostrava

    Ostrava-Poruba, 708 52, Czechia

  • Fakultní Nemocnice Olomouc

    Olomouc, 779 00, Czechia

  • Fond. Istituto Neurologico C.Besta

    Milan, Lombardy, 20133, Italy

  • Fraser Health Authority - Fraser Health Multiple Sclerosis

    Burnaby, British Columbia, V5G 2X6, Canada

  • Fundacion Clinica Valle del Lili

    Cali, Colombia

  • Groupe Hospitalier Pellegrin

    Bordeaux, 33076, France

  • GroupeHospitalo-Universitaire Caremeau

    Nîmes, 30029, France

  • Grupo Medico de Investigacion Clinica Multidisciplinaria

    Mexico City, Mexico CITY (federal District), 03100, Mexico

  • Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

    Sønderborg, 6400, Denmark

  • Hopital B Roger Salengro

    Lille, 59037, France

  • Hopital Cheikh Zaid

    Rabat, 10000, Morocco

  • Hopital Gabriel Montpied CHU de Clermont-Ferrand

    Clermont-Ferrand, 63003, France

  • Hopital Gui de Chauliac

    Montpellier, 34295, France

  • Hopital Militaire d'Instruction Mohamed V

    Rabat, 10100, Morocco

  • Hopital Nord Laennec

    Nantes, 44093, France

  • Hopital neurologique Pierre Wertheimer - CHU Lyon

    Bron, 69677, France

  • Hopitaux Universitaires de Strasbourg

    Strasbourg, 67091, France

  • Hospital Clínica Biblica

    San José, 10101, Costa Rica

  • Hospital General de Mexico

    Mexico, Tlaxcala, 06726, Mexico

  • Hospital Notre-Dame du Centre Hospitalier de l'Universite de Montreal

    Montreal, Quebec, H2L 4M1, Canada

  • Hospital Sao Lucas - PUCRS

    Porto Alegre, Rio Grande do Sul, 90610-000, Brazil

  • Hospital Universitario Virgen de Arrixaca

    Murcia, Spain

  • Hospital Universitario la Fe

    Valencia, 46026, Spain

  • Hospital Vall d'Hebron

    Barcelona, 08035, Spain

  • Hospital das Clinicas - FMUSP_X

    São Paulo, São Paulo, 05403-000, Brazil

  • Hospital das Clínicas Faculdades Médicas de Ribeirão Preto

    Ribeirão Preto, São Paulo, 14051-140, Brazil

  • Hôpital Pasteur

    Nice, 06002, France

  • IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla

    Pavia, Lombardy, 27100, Italy

  • IRCCS Istituto Neurologico Neuromed

    Pozzilli, Molise, 86077, Italy

  • IRCCS Ospedale San Raffaele

    Milan, Lombardy, 20132, Italy

  • Instituto de Neurologia de Curitiba

    Curitiba, Paraná, 81210-310, Brazil

  • Irccs A.O.U.San Martino Ist

    Genoa, Liguria, 16132, Italy

  • Jusupovskaya Hospital

    Moscow, Moscow Oblast, 117186, Russia

  • Jósa András Oktatókórház

    Nyíregyháza, 4400, Hungary

  • Lebanese American University Medical Center- Rizk Hospial

    Beirut, Lebanon

  • London Health Sciences Centre Uni Campus

    London, Ontario, N6A 5A5, Canada

  • Lone Star Neurology of San Antonio

    San Antonio, Texas, 78258, United States

  • MS Center of California

    Laguna Hills, California, 92653, United States

  • Maasstadziekenhuis

    NL -rotterdam, 3079 DZ, Netherlands

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114, United States

  • National Center of Social Significant Disease

    Saint Petersburg, Sankt-Peterburg, 197110, Russia

  • Nemocnice Jihlava

    Jihlava, 58633, Czechia

  • NeuroConcept AG C/O mind mvz GmbH

    Stuttgart, 70182, Germany

  • NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH

    Ulm, 89073, Germany

  • Neurology Clinic PC

    Cordova, Tennessee, 38018, United States

  • Neurology Department, Ain Shams University Hospitals

    Cairo, 11566, Egypt

  • Nucare

    Guatemala City, 01015, Guatemala

  • Organizacion Sanitas Internacional

    Bogotá, Colombia

  • Ospedale Binaghi

    Cagliari, Sardinia, 09126, Italy

  • Ospedale Cattinara

    Trieste, Friuli Venezia Giulia, 34149, Italy

  • Policlinico G.B. Rossi

    Verona, Veneto, 37134, Italy

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

    Rome, Lazio, 00133, Italy

  • Policlinico Universitario A. Gemelli

    Rome, Lazio, 00168, Italy

  • Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika

    Pécs, 7623, Hungary

  • Rashid hospital

    Dubai, United Arab Emirates

  • Recherche Sepmus Inc.

    Greenfield Park, Quebec, J4V 2J2, Canada

  • Rigshospitalet

    Glostrup Municipality, 2600, Denmark

  • SC3 Research Group, Inc

    Pasadena, California, 91105, United States

  • SP Swiecickiego UM Marcinkowskiego

    Późna, 60-355, Poland

  • SPSK nr 1

    Zabrze, 41-800, Poland

  • Saskatoon City Hospital

    Saskatoon, Saskatchewan, S7K 0M7, Canada

  • Semmelweis Egyetem AOK

    Budapest, 1083, Hungary

  • St Vincents University Hospital

    Dublin, Dublin 4, Ireland

  • St. Michael'S Hospital

    Toronto, Ontario, M5B 1W8, Canada

  • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

    Westerstede, 26655, Germany

  • Swedish Multiple Sclerosis Center

    Seattle, Washington, 98122, United States

  • Szpital Uniwersytecki w Krakowie

    Krakow, 31-503, Poland

  • The MS Center of Northeastern New York

    Latham, New York, 12110, United States

  • Unidad de investigacion en salud (UIS)

    Mexico City, 14050, Mexico

  • University Clinical Center Tuzla

    Tuzla, 75000, Bosnia and Herzegovina

  • University Clinical Center of the Republic of Srpska

    Banja Luka, 78000, Bosnia and Herzegovina

  • University Hospital Mostar

    Mostar, 88000, Bosnia and Herzegovina

  • University of British Columbia Hospital

    Vancouver, British Columbia, V6T 2B5, Canada

  • University of California San Francisco

    San Francisco, California, 94158, United States

  • University of Chicago

    Chicago, Illinois, 60637-1470, United States

  • University of Cincinnati

    Cincinnati, Ohio, 45267, United States

  • University of South Florida

    Tampa, Florida, 33613, United States

  • Università degli Studi della Campania Luigi Vanvitelli

    Naples, Campania, 80131, Italy

  • Università degli studi della Campania Luigi Vanvitelli

    Naples, Campania, 80138, Italy

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

    Dresden, 01307, Germany

  • Universitätsmedizin Greifswald

    Greifswald, 17475, Germany

  • Uniwersytecki Szpital Kliniczny w Bialymstoku

    Bialystok, 15-276, Poland

  • VALEOMED Diagnosztikai Központ

    Esztergom, 2500, Hungary

  • Vladimirskiy Regional Scientific Research Inst.

    Moscow, Moscow Oblast, 129110, Russia

  • Vseobecna fakultni nemocnice v Praze

    Prague, 128 08, Czechia

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wayne State University School of Medicine

    Detroit, Michigan, 48210, United States

  • Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy

    Warsaw, 04-141, Poland

  • Zuyderland Medisch Centrum - Sittard Geleen

    Sittard-Geleen, 6162 BG, Netherlands

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