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NCT03523858

PHASE3

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

Sponsor: Hoffmann-La Roche

View on ClinicalTrials.gov

Summary

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

Official title: An Open-Label, Single-Arm 4-Year Study to Evaluate Effectiveness and Safety of Ocrelizumab Treatment in Patients With Progressive Multiple Sclerosis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

927

Start Date

2018-05-28

Completion Date

2026-11-12

Last Updated

2026-01-30

Healthy Volunteers

Conditions

Progressive Multiple Sclerosis (PMS)

Interventions

DRUG

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)

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

Locations (124)

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

Naples, Campania, Italy

Università degli Studi della Campania Luigi Vanvitelli

Naples, Campania, Italy

Università degli studi della Campania Luigi Vanvitelli

Naples, 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

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (124)