A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis
NCT ID: NCT03523858
Last Updated: 2026-01-30
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
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ACTIVE_NOT_RECRUITING
PHASE3
927 participants
INTERVENTIONAL
2018-05-28
2026-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Ocrelizumab
Ocrelizumab will be administered via intravenous (IV) infusion.
Ocrelizumab
Ocrelizumab will be administered via intravenous (IV) infusion at an initial dose of two 300-mg infusions separated by 14 days (on Days 1 and 15), and then 600 mg at every subsequent dose every 24 weeks for the remainder of the study treatment period (approximately 192 weeks)
Interventions
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Ocrelizumab
Ocrelizumab will be administered via intravenous (IV) infusion at an initial dose of two 300-mg infusions separated by 14 days (on Days 1 and 15), and then 600 mg at every subsequent dose every 24 weeks for the remainder of the study treatment period (approximately 192 weeks)
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
65 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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MS Center of California
Laguna Hills, California, United States
SC3 Research Group, Inc
Pasadena, California, United States
University of California San Francisco
San Francisco, California, United States
Yale University
North Haven, Connecticut, United States
University of South Florida
Tampa, Florida, United States
University of Chicago
Chicago, Illinois, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Dragonfly Research, LLC
Wellesley, Massachusetts, United States
Wayne State University School of Medicine
Detroit, Michigan, United States
Washington University School of Medicine
St Louis, Missouri, United States
The MS Center of Northeastern New York
Latham, New York, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic Mellen Center
Cleveland, Ohio, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Neurology Clinic PC
Cordova, Tennessee, United States
Central Texas Neurology Consultants
Round Rock, Texas, United States
Lone Star Neurology of San Antonio
San Antonio, Texas, United States
Swedish Multiple Sclerosis Center
Seattle, Washington, United States
University Clinical Center of the Republic of Srpska
Banja Luka, , Bosnia and Herzegovina
University Hospital Mostar
Mostar, , Bosnia and Herzegovina
Clinical Center University of Sarajevo
Sarajevo, , Bosnia and Herzegovina
University Clinical Center Tuzla
Tuzla, , Bosnia and Herzegovina
Instituto de Neurologia de Curitiba
Curitiba, Paraná, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre, Rio Grande do Sul, Brazil
Hospital das Clínicas Faculdades Médicas de Ribeirão Preto
Ribeirão Preto, São Paulo, Brazil
Hospital das Clinicas - FMUSP_X
São Paulo, São Paulo, Brazil
Fraser Health Authority - Fraser Health Multiple Sclerosis
Burnaby, British Columbia, Canada
University of British Columbia Hospital
Vancouver, British Columbia, Canada
London Health Sciences Centre Uni Campus
London, Ontario, Canada
St. Michael'S Hospital
Toronto, Ontario, Canada
Recherche Sepmus Inc.
Greenfield Park, Quebec, Canada
Hospital Notre-Dame du Centre Hospitalier de l'Universite de Montreal
Montreal, Quebec, Canada
Saskatoon City Hospital
Saskatoon, Saskatchewan, Canada
Organizacion Sanitas Internacional
Bogotá, , Colombia
Fundacion Clinica Valle del Lili
Cali, , Colombia
Hospital Clínica Biblica
San José, , Costa Rica
Nemocnice Jihlava
Jihlava, , Czechia
Fakultní Nemocnice Olomouc
Olomouc, , Czechia
Fakultni nemocnice Ostrava
Ostrava-Poruba, , Czechia
Vseobecna fakultni nemocnice v Praze
Prague, , Czechia
Aarhus Universitetshospital
Aarhus N, , Denmark
Rigshospitalet
Glostrup Municipality, , Denmark
Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken
Sønderborg, , Denmark
Clinical Research Center-Alex university
Alexandria, , Egypt
Neurology Department, Ain Shams University Hospitals
Cairo, , Egypt
CHIC Cote Basque Bayonne
Bayonne, , France
Groupe Hospitalier Pellegrin
Bordeaux, , France
Hopital neurologique Pierre Wertheimer - CHU Lyon
Bron, , France
CHU De Caen
Caen, , France
Hopital Gabriel Montpied CHU de Clermont-Ferrand
Clermont-Ferrand, , France
Hopital B Roger Salengro
Lille, , France
CHU de la Timone - Hopital d Adultes
Marseille, , France
Hopital Gui de Chauliac
Montpellier, , France
CHRU Nancy
Nancy, , France
Hopital Nord Laennec
Nantes, , France
Hôpital Pasteur
Nice, , France
GroupeHospitalo-Universitaire Caremeau
Nîmes, , France
Centre Hospitalier Universitaire de Rennes
Rennes, , France
CHU Amiens Hopital Sud
Salouël, , France
Hopitaux Universitaires de Strasbourg
Strasbourg, , France
Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften
Dresden, , Germany
Universitätsmedizin Greifswald
Greifswald, , Germany
NeuroConcept AG C/O mind mvz GmbH
Stuttgart, , Germany
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
Nucare
Guatemala City, , Guatemala
Semmelweis Egyetem AOK
Budapest, , Hungary
VALEOMED Diagnosztikai Központ
Esztergom, , Hungary
Jósa András Oktatókórház
Nyíregyháza, , Hungary
Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika
Pécs, , Hungary
Cork University Hospital
Cork, , Ireland
Beaumont Hospital
Dublin, , Ireland
St Vincents University Hospital
Dublin, , Ireland
Azienda Ospedaliero Universitaria Consorziale Policlinico di
Bari, Apulia, Italy
A. O. U. Federico II
Napoli, Campania, Italy
Università degli Studi della Campania Luigi Vanvitelli
Napoli, Campania, Italy
Università degli studi della Campania Luigi Vanvitelli
Napoli, Campania, Italy
Ospedale Cattinara
Trieste, Friuli Venezia Giulia, Italy
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla
Rome, Lazio, Italy
Policlinico Universitario A. Gemelli
Rome, Lazio, Italy
A.O. Sant'Andrea
Rome, Lazio, Italy
Azienda Ospedaliera Sant'Andrea
Rome, Lazio, Italy
Irccs A.O.U.San Martino Ist
Genoa, Liguria, Italy
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy
Fond. Istituto Neurologico C.Besta
Milan, Lombardy, Italy
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla
Pavia, Lombardy, Italy
IRCCS Istituto Neurologico Neuromed
Pozzilli, Molise, Italy
Azienda Sanitaria Ospedaliera S. Luigi Gonzaga
Orbassano, Piedmont, Italy
AOU Città della Salute e della Scienza
Turin, Piedmont, Italy
Ospedale Binaghi
Cagliari, Sardinia, Italy
AOU Policlinico V. Emanuele - P.O G. Rodolico
Catania, Sicily, Italy
AOUC Azienda Ospedaliero-Universitaria Careggi
Florence, Tuscany, Italy
Policlinico G.B. Rossi
Verona, Veneto, Italy
American University of Beirut - Medical Center
Beirut, , Lebanon
Lebanese American University Medical Center- Rizk Hospial
Beirut, , Lebanon
Grupo Medico de Investigacion Clinica Multidisciplinaria
Mexico City, Mexico CITY (federal District), Mexico
Clinstile S.A de C.V.
Mexico City, Mexico CITY (federal District), Mexico
Hospital General de Mexico
Mexico, Tlaxcala, Mexico
Unidad de investigacion en salud (UIS)
Mexico City, , Mexico
Centre Hospitalier Universitaire Hassan II
Fes, , Morocco
Hopital Cheikh Zaid
Rabat, , Morocco
Hopital Militaire d'Instruction Mohamed V
Rabat, , Morocco
Amphia Ziekenhuis
Breda, , Netherlands
Catharina ziekenhuis
Eindhoven, , Netherlands
Maasstadziekenhuis
NL -rotterdam, , Netherlands
Zuyderland Medisch Centrum - Sittard Geleen
Sittard-Geleen, , Netherlands
Consultorios Médicos PaItilla
Panama City, , Panama
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
Szpital Uniwersytecki w Krakowie
Krakow, , Poland
Centrum Neurologii Krzysztof Selmaj
Lodz, , Poland
SP Swiecickiego UM Marcinkowskiego
Późna, , Poland
Centrum Medyczne "MEDYK"
Rzeszów, , Poland
Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy
Warsaw, , Poland
SPSK nr 1
Zabrze, , Poland
Jusupovskaya Hospital
Moscow, Moscow Oblast, Russia
Vladimirskiy Regional Scientific Research Inst.
Moscow, Moscow Oblast, Russia
City Clinical Hospital #24
Moskva, Moscow Oblast, Russia
National Center of Social Significant Disease
Saint Petersburg, Sankt-Peterburg, Russia
Hospital Vall d'Hebron
Barcelona, , Spain
Hospital Universitario Virgen de Arrixaca
Murcia, , Spain
Hospital Universitario la Fe
Valencia, , Spain
Cleveland Clinic Abu Dhabi
Abu Dhabi, , United Arab Emirates
Rashid hospital
Dubai, , United Arab Emirates
Countries
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References
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Kappos L, Yiu S, Dahlke F, Coetzee T, Cutter GR, Yuen S, Bonati U, Lublin FD. Composite Confirmed Disability Worsening/Progression Is a Useful Clinical Endpoint for Multiple Sclerosis Clinical Trials. Neurology. 2025 May 27;104(10):e213558. doi: 10.1212/WNL.0000000000213558. Epub 2025 Apr 21.
Other Identifiers
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2017-001313-93
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2023-506429-13-00
Identifier Type: CTIS
Identifier Source: secondary_id
MN39159
Identifier Type: -
Identifier Source: org_study_id
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