A Study to Evaluate Ocrelizumab Treatment in Participants With Progressive Multiple Sclerosis

NCT03523858 | Active Not Recruiting Phase 3 FDA Drug

• 3 other identifiers: MN391592017-001313-932023-506429-13-00
• Study Type: interventional
• Target: 927
• Locations: 23 countries
• Sites: 123

Brief Summary

This study is a prospective, multicenter, open-label, single-arm effectiveness and safety study in participants with progressive multiple sclerosis (PMS).

Conditions

Progressive Multiple Sclerosis (PMS)

Outcome Measures

Primary Outcomes (2)

• Proportion of Participants with No Evidence of Progression (NEP)

  NEP is defined as no progression sustained for at least 24 weeks on all of the following three components (confirmed disability progression \[CDP\]; ≥20% increase in timed 25-foot walk test \[T25FWT\]; ≥20% increase in nine-hole peg test \[9HPT\])

  From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192

• Proportion of Participants with no evidence of progression and no active disease (NEPAD)

  NEPAD is defined as no progression sustained for at least 24 weeks on all of the three components of NEP (CDP, T25FWT, 9HPT), no protocol-defined relapse, no enlarging or new T2 lesion, and no T1 gadolinium (Gd+)-enhancing lesion

  From Baseline to Week 96, Week 96 to Week 192 and Baseline to Week 192

Secondary Outcomes (26)

• Change from Baseline in Cognitive Function, as Measured by the Symbol Digit Modalities Test (SDMT)

  Baseline to end of study (Week 192)

• Change from Baseline in Cognitive Function, as Measured by Brief Visuospatial Memory Test - Revised (BVMT-R)

  Baseline to end of study (Week 192)

• Mean Change from Baseline in the Expanded Disability Status Scale (EDSS) score over the course of the study

  Baseline to end of study (Week 192)

• Time to Onset of First Confirmed Disability Progression (CDP) Sustained for at least 24 and 48 Weeks

  Baseline to onset of first CDP (as measured by EDSS) sustained for at least 24 and 48 weeks

• Time to Onset of First >=20% Increase in Timed 25-foot Walk Test (T25FWT) Sustained for at least 24 Weeks

  Baseline to onset of first >=20% increase in T25FWT sustained for at least 24 weeks

Study Arms (1)

Ocrelizumab

EXPERIMENTAL

Ocrelizumab will be administered via intravenous (IV) infusion.

Drug: Ocrelizumab

Interventions

Ocrelizumab DRUG

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)

Ocrelizumab

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Relapsing-remitting multiple sclerosis (RRMS) at screening
• Inability to complete an MRI
• Gadolinium (Gd) intolerance
• Known presence of other neurological disorders
• 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)
• Positive screening tests for hepatitis B

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (124)

MS Center of California

Laguna Hills, California, 92653, United States

Location

SC3 Research Group, Inc

Pasadena, California, 91105, United States

Location

University of California San Francisco

San Francisco, California, 94158, United States

Location

Yale University

North Haven, Connecticut, 06473, United States

Location

University of South Florida

Tampa, Florida, 33613, United States

Location

University of Chicago

Chicago, Illinois, 60637-1470, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Dragonfly Research, LLC

Wellesley, Massachusetts, 02481, United States

Location

Wayne State University School of Medicine

Detroit, Michigan, 48210, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

The MS Center of Northeastern New York

Latham, New York, 12110, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic Mellen Center

Cleveland, Ohio, 44195, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Neurology Clinic PC

Cordova, Tennessee, 38018, United States

Location

Central Texas Neurology Consultants

Round Rock, Texas, 78681, United States

Location

Lone Star Neurology of San Antonio

San Antonio, Texas, 78258, United States

Location

Swedish Multiple Sclerosis Center

Seattle, Washington, 98122, United States

Location

University Clinical Center of the Republic of Srpska

Banja Luka, 78000, Bosnia and Herzegovina

Location

University Hospital Mostar

Mostar, 88000, Bosnia and Herzegovina

Location

Clinical Center University of Sarajevo

Sarajevo, 71000, Bosnia and Herzegovina

Location

University Clinical Center Tuzla

Tuzla, 75000, Bosnia and Herzegovina

Location

Instituto de Neurologia de Curitiba

Curitiba, Paraná, 81210-310, Brazil

Location

Hospital Sao Lucas - PUCRS

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

Location

Hospital das Clínicas Faculdades Médicas de Ribeirão Preto

Ribeirão Preto, São Paulo, 14051-140, Brazil

Location

Hospital das Clinicas - FMUSP_X

São Paulo, São Paulo, 05403-000, Brazil

Location

Fraser Health Authority - Fraser Health Multiple Sclerosis

Burnaby, British Columbia, V5G 2X6, Canada

Location

University of British Columbia Hospital

Vancouver, British Columbia, V6T 2B5, Canada

Location

London Health Sciences Centre Uni Campus

London, Ontario, N6A 5A5, Canada

Location

St. Michael'S Hospital

Toronto, Ontario, M5B 1W8, Canada

Location

Recherche Sepmus Inc.

Greenfield Park, Quebec, J4V 2J2, Canada

Location

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

Montreal, Quebec, H2L 4M1, Canada

Location

Saskatoon City Hospital

Saskatoon, Saskatchewan, S7K 0M7, Canada

Location

Organizacion Sanitas Internacional

Bogotá, Colombia

Location

Fundacion Clinica Valle del Lili

Cali, Colombia

Location

Hospital Clínica Biblica

San José, 10101, Costa Rica

Location

Nemocnice Jihlava

Jihlava, 58633, Czechia

Location

Fakultní Nemocnice Olomouc

Olomouc, 779 00, Czechia

Location

Fakultni nemocnice Ostrava

Ostrava-Poruba, 708 52, Czechia

Location

Vseobecna fakultni nemocnice v Praze

Prague, 128 08, Czechia

Location

Aarhus Universitetshospital

Aarhus N, 8200, Denmark

Location

Rigshospitalet

Glostrup Municipality, 2600, Denmark

Location

Hjerne- og nervesygdomme, Ambulatorium, Skleroseklinikken

Sønderborg, 6400, Denmark

Location

Clinical Research Center-Alex university

Alexandria, 21561, Egypt

Location

Neurology Department, Ain Shams University Hospitals

Cairo, 11566, Egypt

Location

CHIC Cote Basque Bayonne

Bayonne, 64109, France

Location

Groupe Hospitalier Pellegrin

Bordeaux, 33076, France

Location

Hopital neurologique Pierre Wertheimer - CHU Lyon

Bron, 69677, France

Location

CHU De Caen

Caen, 14033, France

Location

Hopital Gabriel Montpied CHU de Clermont-Ferrand

Clermont-Ferrand, 63003, France

Location

Hopital B Roger Salengro

Lille, 59037, France

Location

CHU de la Timone - Hopital d Adultes

Marseille, 13005, France

Location

Hopital Gui de Chauliac

Montpellier, 34295, France

Location

CHRU Nancy

Nancy, 54035, France

Location

Hopital Nord Laennec

Nantes, 44093, France

Location

Hôpital Pasteur

Nice, 06002, France

Location

GroupeHospitalo-Universitaire Caremeau

Nîmes, 30029, France

Location

Centre Hospitalier Universitaire de Rennes

Rennes, 35033, France

Location

CHU Amiens Hopital Sud

Salouël, 80480, France

Location

Hopitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Universitätsklinikum "Carl Gustav Carus", Zentrum für Klinische Neurowissenschaften

Dresden, 01307, Germany

Location

Universitätsmedizin Greifswald

Greifswald, 17475, Germany

Location

NeuroConcept AG C/O mind mvz GmbH

Stuttgart, 70182, Germany

Location

NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH

Ulm, 89073, Germany

Location

Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

Westerstede, 26655, Germany

Location

Deutsche Klinik für Diagnostik

Wiesbaden, 65191, Germany

Location

Nucare

Guatemala City, 01015, Guatemala

Location

Semmelweis Egyetem AOK

Budapest, 1083, Hungary

Location

VALEOMED Diagnosztikai Központ

Esztergom, 2500, Hungary

Location

Jósa András Oktatókórház

Nyíregyháza, 4400, Hungary

Location

Pécsi Tudományegyetem, Klinikai Központ Neurológiai Klinika

Pécs, 7623, Hungary

Location

Cork University Hospital

Cork, Ireland

Location

Beaumont Hospital

Dublin, 9, Ireland

Location

St Vincents University Hospital

Dublin, Dublin 4, Ireland

Location

Azienda Ospedaliero Universitaria Consorziale Policlinico di

Bari, Apulia, 70124, Italy

Location

A. O. U. Federico II

Naples, Campania, 80131, Italy

Location

Università degli Studi della Campania Luigi Vanvitelli

Naples, Campania, 80131, Italy

Location

Università degli studi della Campania Luigi Vanvitelli

Naples, Campania, 80138, Italy

Location

Ospedale Cattinara

Trieste, Friuli Venezia Giulia, 34149, Italy

Location

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

Rome, Lazio, 00133, Italy

Location

Policlinico Universitario A. Gemelli

Rome, Lazio, 00168, Italy

Location

A.O. Sant'Andrea

Rome, Lazio, 00189, Italy

Location

Azienda Ospedaliera Sant'Andrea

Rome, Lazio, 00189, Italy

Location

Irccs A.O.U.San Martino Ist

Genoa, Liguria, 16132, Italy

Location

IRCCS Ospedale San Raffaele

Milan, Lombardy, 20132, Italy

Location

Fond. Istituto Neurologico C.Besta

Milan, Lombardy, 20133, Italy

Location

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

Pavia, Lombardy, 27100, Italy

Location

IRCCS Istituto Neurologico Neuromed

Pozzilli, Molise, 86077, Italy

Location

Azienda Sanitaria Ospedaliera S. Luigi Gonzaga

Orbassano, Piedmont, 10043, Italy

Location

AOU Città della Salute e della Scienza

Turin, Piedmont, 10126, Italy

Location

Ospedale Binaghi

Cagliari, Sardinia, 09126, Italy

Location

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

Catania, Sicily, 95123, Italy

Location

AOUC Azienda Ospedaliero-Universitaria Careggi

Florence, Tuscany, 50134, Italy

Location

Policlinico G.B. Rossi

Verona, Veneto, 37134, Italy

Location

American University of Beirut - Medical Center

Beirut, 11-236, Lebanon

Location

Lebanese American University Medical Center- Rizk Hospial

Beirut, Lebanon

Location

Grupo Medico de Investigacion Clinica Multidisciplinaria

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

Location

Clinstile S.A de C.V.

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

Location

Hospital General de Mexico

Mexico, Tlaxcala, 06726, Mexico

Location

Unidad de investigacion en salud (UIS)

Mexico City, 14050, Mexico

Location

Centre Hospitalier Universitaire Hassan II

Fes, 30000, Morocco

Location

Hopital Cheikh Zaid

Rabat, 10000, Morocco

Location

Hopital Militaire d'Instruction Mohamed V

Rabat, 10100, Morocco

Location

Amphia Ziekenhuis

Breda, 4818 CK, Netherlands

Location

Catharina ziekenhuis

Eindhoven, 5623 EJ, Netherlands

Location

Maasstadziekenhuis

NL -rotterdam, 3079 DZ, Netherlands

Location

Zuyderland Medisch Centrum - Sittard Geleen

Sittard-Geleen, 6162 BG, Netherlands

Location

Consultorios Médicos PaItilla

Panama City, Panama

Location

Uniwersytecki Szpital Kliniczny w Bialymstoku

Bialystok, 15-276, Poland

Location

Szpital Uniwersytecki w Krakowie

Krakow, 31-503, Poland

Location

Centrum Neurologii Krzysztof Selmaj

Lodz, 90-324, Poland

Location

SP Swiecickiego UM Marcinkowskiego

Późna, 60-355, Poland

Location

Centrum Medyczne "MEDYK"

Rzeszów, 35-055, Poland

Location

Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy

Warsaw, 04-141, Poland

Location

SPSK nr 1

Zabrze, 41-800, Poland

Location

Jusupovskaya Hospital

Moscow, Moscow Oblast, 117186, Russia

Location

Vladimirskiy Regional Scientific Research Inst.

Moscow, Moscow Oblast, 129110, Russia

Location

City Clinical Hospital #24

Moskva, Moscow Oblast, 127015, Russia

Location

National Center of Social Significant Disease

Saint Petersburg, Sankt-Peterburg, 197110, Russia

Location

Hospital Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Universitario Virgen de Arrixaca

Murcia, Spain

Location

Hospital Universitario la Fe

Valencia, 46026, Spain

Location

Cleveland Clinic Abu Dhabi

Abu Dhabi, 112412, United Arab Emirates

Location

Rashid hospital

Dubai, United Arab Emirates

Location

Related Publications (1)

• 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.

  PMID: 40258203 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Chronic Progressive

Interventions

ocrelizumab

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 16, 2018
• First Posted: May 14, 2018
• Study Start: May 28, 2018
• Primary Completion (Estimated): October 22, 2026
• Study Completion (Estimated): October 22, 2026
• Last Updated: April 30, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

ES (3); CA (7); ME (4); BR (4); EG (2); DK (3); HU (4); MO (3); IT (20); NL (4); PA (1); PL (7); AE (2); BO (4); FR (15); RU (4); DE (6); CZ (4); LE (2); CO (2); IE (3); GU (1); US (18)