A Rollover Study to Evaluate the Long-Term Safety and Efficacy of Ocrelizumab In Patients With Multiple Sclerosis

NCT ID: NCT05269004

Last Updated: 2025-12-31

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 1300 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-05-03
• Study Completion Date: 2029-12-31

Brief Summary

This is a Phase IIIb, single-arm, multicenter, OLE study. Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046) are eligible for enrollment in this extension study. Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Ocrelizumab

Participants receiving ocrelizumab as an investigational medicinal product (IMP) in a Roche sponsored Parent study who continue to receive ocrelizumab or are in safety follow-up at the time of the closure of their respective Parent study (WA21092, WA21093 or WA25046). Participants who will continue ocrelizumab treatment will receive IMP based on the dosage and administration received at the time of rollover from the Parent study.

Group Type: EXPERIMENTAL

Ocrelizumab

Intervention Type: DRUG

Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.

Interventions

Ocrelizumab

Ocrelizumab will be administered based on the dosage and administration received at the time of rollover from the Parent study.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Prior eligibility for and previous participation in 1 of the Roche-sponsored Parent Studies WA21092, WA21093, or WA25046 with the participant either receiving ocrelizumab as an investigational medicinal product (IMP) or being in safety follow-up after treatment discontinuation
• For female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use adequate acceptable contraception during the treatment period and for at least 6 months or longer if the local label is more stringent after the final dose of ocrelizumab, as applicable in the ocrelizumab package leaflet

Exclusion Criteria

• Concurrent participation in any clinical trial (other than the Parent study)
• Unable or unwilling to comply with the requirements of the protocol

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hoffmann-La Roche

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

Barrow Neurological Institute

Phoenix, Arizona, United States

Arizona Neuroscience Research LLC

Phoenix, Arizona, United States

MS Center of California

Laguna Hills, California, United States

Stanford Hospital and Clinics

Palo Alto, California, United States

University of California San Francisco

San Francisco, California, United States

University of California San Francisco

San Francisco, California, United States

University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)

Aurora, Colorado, United States

Advanced Neurosciences Research LLC

Fort Collins, Colorado, United States

Neurology Associates PA

Maitland, Florida, United States

University of Miami

Miami, Florida, United States

Neurological Services of Orlando

Orlando, Florida, United States

University of South Florida

Tampa, Florida, United States

Vero Beach Neurology and Research Institute

Vero Beach, Florida, United States

Atlanta Neuroscience Institute

Atlanta, Georgia, United States

Northwestern University

Chicago, Illinois, United States

Consultants in Neurology Ltd

Northbrook, Illinois, United States

Indiana Univ School of Med

Indianapolis, Indiana, United States

Kansas University Medical Center

Kansas City, Kansas, United States

Massachusetts General Hospital

Boston, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States

Henry Ford Hospital

Detroit, Michigan, United States

Michigan Institute for Neurological Disorders

Farmington Hills, Michigan, United States

Minneapolis Clinic of Neurology

Golden Valley, Minnesota, United States

University of Minnesota

Minneapolis, Minnesota, United States

Washington University

St Louis, Missouri, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Rutgers New Jersey Medical School Department of Neurology

Newark, New Jersey, United States

Holy Name Hospital

Teaneck, New Jersey, United States

University of New Mexico

Albuquerque, New Mexico, United States

South Shore Neurologic Associates PC

Patchogue, New York, United States

SUNY at Stony Brook

Stony Brook, New York, United States

OnSite Clinical Solutions LLC

Charlotte, North Carolina, United States

The Neurological Institute PA

Charlotte, North Carolina, United States

Atrium Health

Charlotte, North Carolina, United States

Raleigh Neurology Associates

Raleigh, North Carolina, United States

University Neurology Inc.

Cincinnati, Ohio, United States

Columbus Neuroscience

Westerville, Ohio, United States

Oklahoma Medical Research Foundation

Oklahoma City, Oklahoma, United States

Providence Neurological Specialties

Portland, Oregon, United States

Abington Neurological Associates

Abington, Pennsylvania, United States

Rhode Island Hospital

Providence, Rhode Island, United States

Neurology Clinic PC

Cordova, Tennessee, United States

Sibyl Wray MD Neurology PC

Knoxville, Tennessee, United States

Baylor College of Medicine

Houston, Texas, United States

Uni of Texas Health Science Center At Houston

Houston, Texas, United States

Bhupesh Dihenia M.D. P.A.

Lubbock, Texas, United States

Neurology Center of San Antonio

San Antonio, Texas, United States

University of Vermont Medical Center

Burlington, Vermont, United States

Swedish Neuroscience Institute

Seattle, Washington, United States

MultiCare Health System Institute for Research and Innovation

Tacoma, Washington, United States

Hospital Español

Ciudad Autonoma Bs As, , Argentina

Fundacion Rosarina de Neurorehabilitacion

Rosario, , Argentina

Royal North Shore Hospital

St Leonards, New South Wales, Australia

St Vincent's Hospital Melbourne

Fitzroy, Victoria, Australia

Medizinische Universität Innsbruck

Innsbruck, , Austria

Barmherzige Brueder Konventspital

Linz, , Austria

AKH - Medizinische Universität Wien

Vienna, , Austria

Grodno University Hospital

Grodno, Brest Oblast, Belarus

State Institution Minsk Research and Practice Center of Surgery Transplantation and Hematology

Minsk, , Belarus

Vitebsk Regional Clinical Hospital

Vitebsk, , Belarus

AZ Sint Jan

Bruges, , Belgium

Cliniques Universitaires Saint-Luc

Brussels, , Belgium

UZA

Edegem, , Belgium

Algemeen Ziekenhuis Alma

Eeklo, , Belgium

AZ Delta Campus Westlaan

Roeselare, , Belgium

HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás

Goinia, Goiás, Brazil

Hospital So Lucas da PUCRS

Porto Alegre, Rio Grande do Sul, Brazil

IMV Pesquisa Neurologica Sociedade Simples Ltda

Porto Alegre, Rio Grande do Sul, Brazil

Clinica Neurológica e Neurocirúrgica de Joinville

Joinville, Santa Catarina, Brazil

Hospital Universitario Gaffree e Guinle

Rio de Janeiro, , Brazil

HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho Universidade Federal do Rio de Janeiro

Rio de Janeiro, , Brazil

MHAT Avis Medica OOD Department of Neurology

Pleven, , Bulgaria

MHATNP Sveti Naum EAD

Sofia, , Bulgaria

University First MHAT-Sofia St. Joan Krastitel EAD

Sofia, , Bulgaria

National Heart Hospital EAD

Sofia, , Bulgaria

Acibadem City Clinic Tokuda Hospital Ead

Sofia, , Bulgaria

Military Medical Academy MHAT Sofia Department of Rheumatology

Sofia, , Bulgaria

Calgary MS Clinic

Calgary, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

UBC Multiple Sclerosis & Neuromyelitis Optica NMO Clinical Trials

Vancouver, British Columbia, Canada

The Ottawa Hospital - General Campus

Ottawa, Ontario, Canada

St Michael Hospital

Toronto, Ontario, Canada

Clinique Neuro Outaouais

Gatineau, Quebec, Canada

Recherche Sepmus Inc.

Greenfield Park, Quebec, Canada

Montreal Neurological Institute and Hospital

Montreal, Quebec, Canada

General Hospital Varazdin

Varaždin, , Croatia

University Hospital Center Zagreb

Zagreb, , Croatia

Fakultni nemocnice Brno

Brno, , Czechia

Fakultni nemocnice u sv. Anny v Brne

Brno, , Czechia

Neurospol s.r.o.

Havirov-Podlesi, , Czechia

Fakultni nemocnice Hradec Kralove

Hradec Králové, , Czechia

Nemocnice Jihlava

Jihlava, , Czechia

Pardubicka krajska nemocnice a.s.

Pardubice, , Czechia

Vseobecna fakultni nemocnice v Praze

Prague, , Czechia

Krajska zdravotni a.s. - Nemocnice Teplice o.z.

Teplice, , Czechia

West Tallinn Central Hospital

Tallinn, , Estonia

Tartu University Hospital

Tartu, , Estonia

Tammer Tutka Oy

Tampere, , Finland

CHU CAEN - Hôpital de la Côte de Nacre

Caen, Calvados, France

CHU Nancy Hôpital Central

Nancy, Meurthe Et Moselle, France

Groupe Hospitalier Pellegrin

Bordeaux, , France

Hopital Neurologique Pierre Wertheimer

Bron, , France

CHU Hopital Gabriel Montpied

Clermont-Ferrand, , France

Hopital Roger Salengro Service de Neurologie

Lille, , France

CHU Nice - Hôpital Pasteur 2

Nice, , France

Centre Hospitalier Intercommunal de Poissy

Poissy, , France

CHU Strasbourg Hpital Hautepierre

Strasbourg, , France

Universitaetsklinikum Tuebingen

Tübingen, Baden-Wurttemberg, Germany

Universitätsklinikum Ulm

Ulm, Baden-Wurttemberg, Germany

Klinikum Bayreuth GmbH

Bayreuth, Bavaria, Germany

Klinikum rechts der Isar der TU Muenchen

Munich, Bavaria, Germany

Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz

Westerstede, Lower Saxony, Germany

Universitaetsklinikum Duesseldorf

Düsseldorf, North Rhine-Westphalia, Germany

Pharmakologisches Studienzentrum

Chemnitz, Saxony, Germany

Universitaetsklinikum Leipzig

Leipzig, Saxony, Germany

Charité Universitaetsmedizin Berlin - Campus Ch

Berlin, , Germany

Jüdisches Krankenhaus Berlin

Berlin, , Germany

Neurologie in Bonn

Bonn, , Germany

Universitaetsklinikum Carl Gustav Carus TU Dresden

Dresden, , Germany

Zentrum fuer ambulante Neurologie

Essen, , Germany

Klinikum der Johann Wolfgang Goethe-Universitaet

Frankfurt, , Germany

Universitaetsklinikum Giessen und Marburg GmbH

Giessen, , Germany

Universitaetsklinikum Muenster

Münster, , Germany

Medizinische Einrichtungen des Bezirks Oberpfalz GmbH

Regensburg, , Germany

S-Medicon Egeszsegugyi Szolgaltato Kft.

Budapest, , Hungary

Jahn Ferenc Del-Pesti Korhaz es Rendelointezet

Budapest, , Hungary

Pecsi Tudomanyegyetem

Pécs, , Hungary

Hadassah University Hospital - Ein Kerem

Jerusalem, , Israel

Rabin Medical Center Beilinson Campus

Petah Tikva, , Israel

Chaim Sheba Medical Center

Ramat Gan, , Israel

Tel Aviv Sourasky Medical Center

Tel Aviv, , Israel

Azienda Socio Sanitaria Territoriale della Valle Olona (pres

Gallarate, Aosta Valley, Italy

Ospedale degli Infermi

Ponderano, Friuli Venezia Giulia, Italy

Azienda Ospedaliera Universitaria Policlinico Tor Vergata

Rome, Lazio, Italy

Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien

Rome, Lazio, Italy

IRCCS Ospedale Policlinico San Martino

Genoa, Liguria, Italy

Ospedale San Raffaele

Milan, Lombardy, Italy

Fondazione IRCCS Istituto Neurologico Carlo Besta

Milan, Lombardy, Italy

Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)

Montichiari, Lombardy, Italy

Azienda Sanitaria Ospedaliera S Luigi Gonzaga

Orbassano, Piedmont, Italy

Fondazione Istituto G. Giglio di Cefalu

Cefalù, Sicily, Italy

Azienda Ospedaliero Universitaria Ospedali Riuniti

Torrette Di Ancona, The Marches, Italy

Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology

Riga, , Latvia

Pauls Stradins Clinical University Hospital

Riga, , Latvia

Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution

Kaunas, , Lithuania

Klaipeda University Hospital Public Institution

Klaipėda, , Lithuania

Vilnius University Hospital Santaros Klinikos

Vilnius, , Lithuania

Hospital Mexico Americano

Guadalajara, Mexico CITY (federal District), Mexico

Mexico Centre for Clinical Research

Mexico City, Mexico CITY (federal District), Mexico

Clinical Research Institute

Tlalnepantla, Mexico CITY (federal District), Mexico

Hospital Universitario Dr Jose Eleuterio Gonzalez

Monterrey, Nuevo León, Mexico

Centro de Estudios Clinicos y Especialidades Medicas S C

Monterrey, Nuevo León, Mexico

Neurociencias Estudios Clinicos S.C.

Culiacán, Sinaloa, Mexico

Hospital Angeles Chihuahua

Chihuahua City, , Mexico

Grupo Medico Camino

México, , Mexico

Zuyderland Medisch Centrum - Sittard-Geleen'

Sittard-Geleen, , Netherlands

Waikato Hospital

Hamilton, , New Zealand

Haukeland Universitetssykehus

Bergen, , Norway

NZOZ Vitamed

Bydgoszcz, , Poland

COPERNICUS Podmiot Leczniczy Sp z o o

Gda?sk, , Poland

M.A. LEK A.M.Maciejowscy SC.

Katowice, , Poland

Specjal. Praktyka Lekarska

Katowice, , Poland

Neuro-Medic Janusz Zbrojkiewicz

Katowice, , Poland

Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K

Krakow, , Poland

Centrum Neurologii Krzysztof Selmaj

Lodz, , Poland

Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie

Lublin, , Poland

Wojewodzki Specjalistyczny Szpital w Olsztynie

Olsztyn, , Poland

Neurologiczny NZOZ Centrum Leczenia SM

Plewiska, , Poland

Neuro-Care Gabriela Klodowska

Siemianowice ?l?skie, , Poland

Centrum Medyczne NeuroProtect

Warsaw, , Poland

Centro Clnico Acadmico - Braga, Associao (2CA-Braga)

Braga, , Portugal

Centro Hospitalar do Porto, E.P.E. - Hospital de Santo Antnio

Coimbra, , Portugal

Unidade Local de Saude de Santa Maria, E.P.E. - Hospital de Santa Maria

Lisbon, , Portugal

Hospital Garcia de Orta

Pragal, , Portugal

Spitalul Universitar de Urgenta Elias

Bucharest, , Romania

SC Clubul Sanatatii SRL

Campulung Muscel, , Romania

Siberian Medical Center

Barnaul, Altayskiy Kray, Russia

FSBI 'Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Techno

Moscow, Moscow Oblast, Russia

SBIH City Polyclinic 2 of the Department of Health of the City of Moscow

Moscow, Moscow Oblast, Russia

SBIH of Republic Mordoviya "Republican Clinical Hospital # 4"

Saransk, Respublika Mordoviya, Russia

FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF

Saint Petersburg, Sankt-Peterburg, Russia

SPb SBIH "City Multy-field Hospital # 2"

Saint Petersburg, Sankt-Peterburg, Russia

Pavlov First Saint Petersburg State Medical University

Saint Petersburg, Sankt-Peterburg, Russia

SBIH of Stavropol territory " City Hospital # 2" of Pyatigorsk

Pyatigorsk, Stavropol Kray, Russia

Sverdlovsk Regional Clinical Hospital 1

Yekaterinburg, Sverdlovsk Oblast, Russia

Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik

Tyumen, Tyumen Oblast, Russia

SAHI "Interregional Clinical and Diagnostic Center"

Kazan, Vologda Oblast, Russia

SAIH "Kemerovo Regional Clinical Hospital"

Kemerovo, , Russia

Kirov RSBIH "Kirov City Clinical Hospital # 1"

Kirov, , Russia

FSBIH Siberian Clinical Center of FMBA of Novosibirsk

Novosibirsk, , Russia

SBEI HPE " Perm State Medical University n.a. Academician E.A. Vagner" of the MoH of the RF

Perm, , Russia

SBEI HPE "Samara State Medical University" of the MoH of the RF

Samara, , Russia

Saratov State Medical University

Saratov, , Russia

RSBIH "Smolensk Regional Clinical Hospital"

Smolensk, , Russia

Clinical Center Kragujevac

Kragujevac, , Serbia

Clinical Center Nis

Niš, , Serbia

MUDr. Beata Dupejova Neurologicka ambulancia s.r.o

Banská Bystrica, , Slovakia

Univerzitna nemocnica Bratislava Nemocnica Ruzinov

Bratislava, , Slovakia

Fakultna nemocnica s poliklinikou Zilina

Žilina, , Slovakia

Hospital Universitari de Bellvitge

L'Hospitalet de Llobregat, Barcelona, Spain

Hospital Santa Caterina

Salt, Girona, Spain

Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia

Santiago de Compostela, LA Coruna, Spain

Hospital Universitario Puerta de Hierro - Majadahonda

Majadahonda, Madrid, Spain

Hospital de Basurto

Bilbao, Vizcaya, Spain

Hospital Vall d'Hebron

Barcelona, , Spain

Hospital Universitario de la Princesa

Madrid, , Spain

Hospital Universitario Ramon y Cajal

Madrid, , Spain

Hospital Universitario Clínico San Carlos

Madrid, , Spain

Hospital Regional Universitario de Malaga

Málaga, , Spain

Hospital Universitario Virgen Macarena

Seville, , Spain

Sahlgrenska Sjukhuset

Gothenburg, , Sweden

Akademiskt Specialist Centrum

Stockholm, , Sweden

Universitaetsspital Basel

Basel, , Switzerland

Ospedale Regionale di Lugano

Lugano, , Switzerland

Hopital Razi

Mannouba, , Tunisia

Hopital Universitaire Fattouma Bourguiba

Monastir, , Tunisia

Istanbul University Cerrahpasa Medical Faculty

Istanbul, , Turkey (Türkiye)

Ondokuz Mayis Univ. Med. Fac.

Samsun, , Turkey (Türkiye)

Karadeniz Tecnical Uni. Med. Fac

Trabzon, , Turkey (Türkiye)

Medical Center of Limited Liability Company Medical Center Saliutem

Vinnytsia, Chernihiv Governorate, Ukraine

Separated structural unit ?University hospital? of Dnipro State Medical University

Dnipro, Dnipropetrovsk Oblast, Ukraine

Institute of Neurology Psychiatry and Narcology of NAMS of Ukraine

Kharkiv, Kharkiv Governorate, Ukraine

Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital

Lviv, Kharkiv Governorate, Ukraine

CMPI Chernihiv Regional Hospital

Chernihiv, KIEV Governorate, Ukraine

CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council

Ivano-Frankivsk, KIEV Governorate, Ukraine

Medical Center of Limited Liability Company Medbud-Clinic

Kyiv, KIEV Governorate, Ukraine

CNE of Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU

Lviv, KIEV Governorate, Ukraine

CNE Odesa Regional Clinical Hospital of Odesa Regional Council

Odesa, KIEV Governorate, Ukraine

Nottingham University Hospitals Queen's Medical Centre

Nottingham, Nottinghamshire, United Kingdom

Royal Devon and Exeter Hospital (Wonford)

Exeter, , United Kingdom

Walton Centre For Neurology and Neurosurgery

Liverpool, , United Kingdom

Barts Health NHS Trust

London, , United Kingdom

Royal Victoria Infirmary

Newcastle, , United Kingdom

Morriston Hospital

Swansea, , United Kingdom

Countries

United States; Argentina; Australia; Austria; Belarus; Belgium; Brazil; Bulgaria; Canada; Croatia; Czechia; Estonia; Finland; France; Germany; Hungary; Israel; Italy; Latvia; Lithuania; Mexico; Netherlands; New Zealand; Norway; Poland; Portugal; Romania; Russia; Serbia; Slovakia; Spain; Sweden; Switzerland; Tunisia; Turkey (Türkiye); Ukraine; United Kingdom

Other Identifiers

2021-005746-15

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MN43964

Identifier Type: -

Identifier Source: org_study_id