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

A Multicenter, Single-Arm, Open-Label, Extension, Rollover Study To Evaluate The Long-Term Safety And Efficacy Of Ocrelizumab In Patients With Multiple Sclerosis

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Drug: Ocrelizumab

• Study Type: Interventional
• Enrollment (Estimated): 1300
• Phase: Phase 3

Contacts and Locations

Study Locations

• Argentina
  • Ciudad Autonoma Bs As, Argentina, 1209
    • Hospital Español
  • Rosario, Argentina, 2000
    • Fundacion Rosarina de Neurorehabilitacion
• Australia
  • New South Wales
    • St Leonards, New South Wales, Australia, NSW 2065
      • Royal North Shore Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
• Austria
  • Innsbruck, Austria, 6020
    • Department Neurologie und Neurochirurgie
  • Linz, Austria, 4040
    • Barmherzige Brueder Konventspital
  • Vienna, Austria, 1090
    • AKH - Medizinische Universitat Wien
• Belarus
  • Minsk, Belarus, 2200045
    • State Institution Minsk Research and Practice Center of Surgery Transplantation and Hematology
  • Vitebsk, Belarus, 210037
    • Vitebsk Regional Clinical Hospital
  • Brest Oblast
    • Grodno, Brest Oblast, Belarus, 230017
      • Grodno University Hospital
• Belgium
  • Bruges, Belgium, 8000
    • AZ Sint Jan
  • Brussels, Belgium, 1200
    • Cliniques Universitaires Saint-luc
  • Edegem, Belgium, 2650
    • UZA
  • Eeklo, Belgium, 9900
    • Algemeen Ziekenhuis Alma
  • Roeselare, Belgium, 8800
    • AZ Delta Campus Westlaan
• Brazil
  • Rio de Janeiro, Brazil, 20270-004
    • Hospital Universitario Gaffree e Guinle
  • Rio de Janeiro, Brazil, 21941-913
    • HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho Universidade Federal do Rio de Janeiro
  • Goiás
    • Goinia, Goiás, Brazil, 74605-020
      • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
  • Rio Grande do Sul
    • Porto Alegre, Rio Grande do Sul, Brazil, 90610-000
      • Hospital So Lucas da PUCRS
    • Porto Alegre, Rio Grande do Sul, Brazil, 90620-130
      • IMV Pesquisa Neurologica Sociedade Simples Ltda
  • Santa Catarina
    • Joinville, Santa Catarina, Brazil, 89202-165
      • Clinica Neurologica e Neurocirurgica de Joinville
• Bulgaria
  • Pleven, Bulgaria, 5800
    • MHAT Avis Medica OOD Department of Neurology
  • Sofia, Bulgaria, 1113
    • MHATNP Sveti Naum EAD
  • Sofia, Bulgaria, 1407
    • Acibadem City Clinic Tokuda Hospital Ead
  • Sofia, Bulgaria, 1142
    • University First MHAT-Sofia St. Joan Krastitel EAD
  • Sofia, Bulgaria, 1309
    • National Heart Hospital EAD
  • Sofia, Bulgaria, 1606
    • Military Medical Academy MHAT Sofia Department of Rheumatology
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Foothills Medical Centre Multiple Sclerosis Clinic
    • Edmonton, Alberta, Canada, T6G 2C8
      • University of Alberta
  • British Columbia
    • Vancouver, British Columbia, Canada, V6T 2B5
      • UBC Multiple Sclerosis & Neuromyelitis Optica NMO Clinical Trials
  • Ontario
    • Ottawa, Ontario, Canada, K1H 8L6
      • The Ottawa Hospital - General Campus
    • Toronto, Ontario, Canada, M5B 1W8
      • St Michael Hospital
  • Quebec
    • Gatineau, Quebec, Canada, J8Y 1W2
      • Clinique Neuro Outaouais
    • Greenfield Park, Quebec, Canada, J4V 2J2
      • Recherche Sepmus Inc.
    • Montreal, Quebec, Canada, H3A 2B4
      • Montreal Neurological Institute and Hospital
• Croatia
  • Varaždin, Croatia, 42000
    • General Hospital Varazdin
  • Zagreb, Croatia, 10000
    • University Hospital Center Zagreb
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne
  • Brno, Czechia, 625 00
    • Fakultni nemocnice Brno
  • Havirov-Podlesi, Czechia, 73601
    • Neurospol s.r.o.
  • Hradec Králové, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Jihlava, Czechia, 58633
    • Nemocnice Jihlava
  • Pardubice, Czechia, 532 03
    • Pardubicka krajska nemocnice a.s.
  • Prague, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
  • Teplice, Czechia, 41529
    • Krajska zdravotni a.s. - Nemocnice Teplice o.z.
• Estonia
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
  • Tartu, Estonia, 50406
    • Tartu University Hospital
• Finland
  • Tampere, Finland, 33200
    • Tammer Tutka Oy
• France
  • Bordeaux, France, 33076
    • Groupe Hospitalier Pellegrin
  • Bron, France, 69500
    • Hopital Neurologique Pierre Wertheimer
  • Clermont-Ferrand, France, 63003
    • CHU Hôpital Gabriel Montpied
  • Lille, France
    • Hopital Roger Salengro Service de Neurologie
  • Nice, France, 06002
    • CHU Nice - Hôpital Pasteur 2
  • Poissy, France, 78300
    • Centre Hospitalier Intercommunal de Poissy
  • Strasbourg, France, 67098
    • CHU Strasbourg Hpital Hautepierre
  • Calvados
    • Caen, Calvados, France, 14033
      • Chu Caen - Hôpital de La Côte de Nacre
  • Meurthe Et Moselle
    • Nancy, Meurthe Et Moselle, France, 54035
      • CHU Nancy Hôpital Central
• Germany
  • Berlin, Germany, 13347
    • Judisches Krankenhaus Berlin
  • Berlin, Germany, 10117
    • Charité Universitaetsmedizin Berlin - Campus Ch
  • Bonn, Germany, 53111
    • Neurologie in Bonn
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Essen, Germany, 45138
    • Zentrum fuer ambulante Neurologie
  • Frankfurt, Germany, 60528
    • Klinikum Der Johann Wolfgang Goethe-Universitaet
  • Giessen, Germany, 35392
    • Universitaetsklinikum Giessen und Marburg GmbH
  • Münster, Germany, 48149
    • Universitaetsklinikum Muenster
  • Regensburg, Germany, 93053
    • Medizinische Einrichtungen des Bezirks Oberpfalz GmbH
  • Baden-Wurttemberg
    • Tübingen, Baden-Wurttemberg, Germany, 72076
      • Universitaetsklinikum Tuebingen
    • Ulm, Baden-Wurttemberg, Germany, 89081
      • Universitatsklinikum Ulm
  • Bavaria
    • Bayreuth, Bavaria, Germany, 95445
      • Klinikum Bayreuth GmbH
    • Munich, Bavaria, Germany, 81675
      • Klinikum rechts der Isar der TU Muenchen
  • Lower Saxony
    • Westerstede, Lower Saxony, Germany, 26655
      • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
  • North Rhine-Westphalia
    • Düsseldorf, North Rhine-Westphalia, Germany, 40225
      • Universitaetsklinikum Duesseldorf
  • Saxony
    • Chemnitz, Saxony, Germany, 09111
      • Pharmakologisches Studienzentrum
    • Leipzig, Saxony, Germany, 04103
      • Universitaetsklinikum Leipzig
• Hungary
  • Budapest, Hungary, 1204
    • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
  • Budapest, Hungary, 1044
    • S-Medicon Egeszsegugyi Szolgaltato Kft.
  • Pécs, Hungary, 7623
    • Pecsi Tudomanyegyetem
• Israel
  • Jerusalem, Israel, 91120
    • Hadassah University Hospital - Ein Kerem
  • Petah Tikva, Israel, 4941492
    • Rabin Medical Center Beilinson Campus
  • Ramat Gan, Israel, 52621
    • Chaim Sheba Medical Center
  • Tel Aviv, Israel, 64239
    • Tel Aviv Sourasky Medical Center
• Italy
  • Aosta Valley
    • Gallarate, Aosta Valley, Italy, 21013
      • Azienda Socio Sanitaria Territoriale della Valle Olona (pres
  • Friuli Venezia Giulia
    • Ponderano, Friuli Venezia Giulia, Italy, 13875
      • Ospedale degli Infermi
  • Lazio
    • Rome, Lazio, Italy, 00133
      • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
    • Rome, Lazio, Italy, 00189
      • Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
  • Liguria
    • Genoa, Liguria, Italy, 16132
      • IRCCS AOM Azienda Ospedaliera Metropolitana
  • Lombardy
    • Milan, Lombardy, Italy, 20132
      • Ospedale San Raffaele
    • Milan, Lombardy, Italy, 20133
      • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Montichiari, Lombardy, Italy, 25018
      • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
  • Piedmont
    • Orbassano, Piedmont, Italy, 10043
      • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
  • Sicily
    • Cefalù, Sicily, Italy, 90015
      • Fondazione Istituto G. Giglio di Cefalu
  • The Marches
    • Torrette Di Ancona, The Marches, Italy, 60126
      • Azienda Ospedaliero Universitaria Ospedali Riuniti
• Latvia
  • Riga, Latvia, LV-1002
    • Pauls Stradins Clinical University Hospital
  • Riga, Latvia, 1015
    • Maritime Medicine Centre of Latvia Hospital of Vecmilgravis Department of Neurology
• Lithuania
  • Kaunas, Lithuania, LT-50161
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
  • Klaipėda, Lithuania, 92288
    • Klaipeda University Hospital Public Institution
  • Vilnius, Lithuania, LT-08661
    • Vilnius University Hospital Santaros Klinikos
• Mexico
  • Chihuahua City, Mexico, 31217
    • Hospital Angeles Chihuahua
  • México, Mexico, 03100
    • Grupo Medico Camino
  • Mexico CITY (federal District)
    • Guadalajara, Mexico CITY (federal District), Mexico, 44610
      • Hospital Mexico Americano
    • Mexico City, Mexico CITY (federal District), Mexico, 03100
      • Mexico Centre for Clinical Research
    • Tlalnepantla, Mexico CITY (federal District), Mexico, 54055
      • Clinical Research Institute
  • Nuevo León
    • Monterrey, Nuevo León, Mexico, 64460
      • Hospital Universitario Dr Jose Eleuterio Gonzalez
    • Monterrey, Nuevo León, Mexico, 64620
      • Centro de Estudios Clinicos y Especialidades Medicas S C
  • Sinaloa
    • Culiacán, Sinaloa, Mexico, 80020
      • Neurociencias Estudios Clinicos S.C.
• Netherlands
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum - Sittard-Geleen'
• New Zealand
  • Hamilton, New Zealand, 3248
    • Waikato Hospital
• Norway
  • Bergen, Norway, 5021
    • Haukeland Universitetssykehus
• Poland
  • Bydgoszcz, Poland, 85-079
    • NZOZ Vitamed
  • Gda?sk, Poland, 80-803
    • COPERNICUS Podmiot Leczniczy Sp z o o
  • Katowice, Poland, 40-571
    • M.A. LEK A.M.Maciejowscy SC.
  • Katowice, Poland, 40-686
    • Neuro-Medic Janusz Zbrojkiewicz
  • Katowice, Poland, 40-588
    • Specjal. Praktyka Lekarska
  • Krakow, Poland, 31-505
    • Krakowska Akademia Neurologii Sp z o.o. Centrum Neurologii K
  • Lodz, Poland, 90-324
    • Centrum Neurologii Krzysztof Selmaj
  • Lublin, Poland, 20-954
    • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
  • Olsztyn, Poland, 10-561
    • Wojewodzki Specjalistyczny Szpital w Olsztynie
  • Plewiska, Poland, 62-064
    • Neurologiczny NZOZ Centrum Leczenia SM
  • Siemianowice ?l?skie, Poland, 41-100
    • Neuro-Care Gabriela Klodowska
  • Warsaw, Poland, 01-684
    • Centrum Medyczne NeuroProtect
• Portugal
  • Braga, Portugal, 4710-243
    • Centro Clnico Acadmico - Braga, Associao (2CA-Braga)
  • Coimbra, Portugal, 3000-075
    • Centro Hospitalar do Porto, E.P.E. - Hospital de Santo Antnio
  • Lisbon, Portugal, 1649-035
    • Unidade Local de Saude de Santa Maria, E.P.E. - Hospital de Santa Maria
  • Pragal, Portugal, 2808-267
    • Hospital Garcia de Orta
• Romania
  • Bucharest, Romania, 11461
    • Spitalul Universitar de Urgenta Elias
  • Campulung Muscel, Romania, 115100
    • SC Clubul Sanatatii SRL
• Russia
  • Kemerovo, Russia, 650066
    • SAIH "Kemerovo Regional Clinical Hospital"
  • Kirov, Russia, 610014
    • Kirov RSBIH "Kirov City Clinical Hospital # 1"
  • Novosibirsk, Russia, 630007
    • FSBIH Siberian Clinical Center of FMBA of Novosibirsk
  • Perm, Russia, 614000
    • SBEI HPE " Perm State Medical University n.a. Academician E.A. Vagner" of the MoH of the RF
  • Samara, Russia, 443095
    • SBEI HPE "Samara State Medical University" of the MoH of the RF
  • Saratov, Russia, 410012
    • Saratov State Medical University
  • Smolensk, Russia, 214018
    • RSBIH "Smolensk Regional Clinical Hospital"
  • Altayskiy Kray
    • Barnaul, Altayskiy Kray, Russia, 656043
      • Siberian Medical Center
  • Moscow Oblast
    • Moscow, Moscow Oblast, Russia, 115682
      • FSBI 'Federal Scientific and Clinical Center of Specialized Types of Medical Care and Medical Techno
    • Moscow, Moscow Oblast, Russia, 117556
      • SBIH City Polyclinic 2 of the Department of Health of the City of Moscow
  • Respublika Mordoviya
    • Saransk, Respublika Mordoviya, Russia, 430032
      • SBIH of Republic Mordoviya "Republican Clinical Hospital # 4"
  • Sankt-Peterburg
    • Saint Petersburg, Sankt-Peterburg, Russia, 194044
      • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF
    • Saint Petersburg, Sankt-Peterburg, Russia, 194354
      • SPb SBIH "City Multy-field Hospital # 2"
    • Saint Petersburg, Sankt-Peterburg, Russia, 197022
      • Pavlov First Saint Petersburg State Medical University
  • Stavropol Kray
    • Pyatigorsk, Stavropol Kray, Russia, 357538
      • SBIH of Stavropol territory " City Hospital # 2" of Pyatigorsk
  • Sverdlovsk Oblast
    • Yekaterinburg, Sverdlovsk Oblast, Russia, 620102
      • Sverdlovsk Regional Clinical Hospital 1
  • Tyumen Oblast
    • Tyumen, Tyumen Oblast, Russia, 625000
      • Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik
  • Vologda Oblast
    • Kazan, Vologda Oblast, Russia, 420101
      • SAHI "Interregional Clinical and Diagnostic Center"
• Serbia
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • Niš, Serbia, 18000
    • Clinical Center Nis
• Slovakia
  • Banská Bystrica, Slovakia, 974 04
    • MUDr. Beata Dupejova Neurologicka ambulancia s.r.o
  • Bratislava, Slovakia, 821 01
    • Univerzitna nemocnica Bratislava Nemocnica Ruzinov
  • Žilina, Slovakia, 012 07
    • Fakultna nemocnica s poliklinikou Zilina
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos
  • Málaga, Spain, 29010
    • Hospital Regional Universitario de Malaga
  • Seville, Spain, 41009
    • Hospital Universitario Virgen Macarena
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge
  • Girona
    • Salt, Girona, Spain, 17190
      • Hospital Santa Caterina
  • LA Coruna
    • Santiago de Compostela, LA Coruna, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
  • Madrid
    • Majadahonda, Madrid, Spain, 28222
      • Hospital Universitario Puerta de Hierro - Majadahonda
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital de Basurto
• Sweden
  • Gothenburg, Sweden, 41345
    • Sahlgrenska Sjukhuset
  • Stockholm, Sweden, 141 86
    • Karolinska Universitetssjukhuset Huddinge
  • Stockholm, Sweden, 113 65
    • Akademiskt Specialist Centrum
• Switzerland
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel
  • Lugano, Switzerland, 6903
    • Ospedale Regionale di Lugano
• Tunisia
  • Mannouba, Tunisia, 2010
    • Hopital Razi
  • Monastir, Tunisia, 5000
    • Hopital Universitaire Fattouma Bourguiba
• Turkey (Türkiye)
  • Istanbul, Turkey (Türkiye), 34098
    • Istanbul University Cerrahpasa Medical Faculty
  • Samsun, Turkey (Türkiye), 55139
    • Ondokuz Mayis Univ. Med. Fac.
  • Trabzon, Turkey (Türkiye), 61080
    • Karadeniz Tecnical Uni. Med. Fac
• Ukraine
  • Chernihiv Governorate
    • Vinnytsia, Chernihiv Governorate, Ukraine, 21050
      • Medical Center of Limited Liability Company Medical Center Saliutem
  • Dnipropetrovsk Oblast
    • Dnipro, Dnipropetrovsk Oblast, Ukraine, 49089
      • Separated structural unit ?University hospital? of Dnipro State Medical University
  • KIEV Governorate
    • Chernihiv, KIEV Governorate, Ukraine, 14029
      • CMPI Chernihiv Regional Hospital
    • Ivano-Frankivsk, KIEV Governorate, Ukraine, 76008
      • CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
    • Kyiv, KIEV Governorate, Ukraine, 03037
      • Medical Center of Limited Liability Company Medbud-Clinic
    • Lviv, KIEV Governorate, Ukraine, 79010
      • CNE of Lviv Reg Clin Hospital Dept of Neurology D.Halytskyi Lviv NMU
    • Odesa, KIEV Governorate, Ukraine, 65025
      • CNE Odesa Regional Clinical Hospital of Odesa Regional Council
  • Kharkiv Governorate
    • Kharkiv, Kharkiv Governorate, Ukraine, 61068
      • Institute of Neurology Psychiatry and Narcology of NAMS of Ukraine
    • Lviv, Kharkiv Governorate, Ukraine, 79010
      • Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
• United Kingdom
  • Exeter, United Kingdom, EX2 5DW
    • Royal Devon and Exeter Hospital (Wonford)
  • Liverpool, United Kingdom, L9 7LJ
    • Walton Centre For Neurology And Neurosurgery
  • London, United Kingdom, E1 1BB
    • Barts Health NHS Trust
  • Newcastle, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Swansea, United Kingdom, SA6 6NL
    • Morriston Hospital
  • Nottinghamshire
    • Nottingham, Nottinghamshire, United Kingdom, NG7 2UH
      • Nottingham University Hospitals Queen's Medical Centre
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
    • Phoenix, Arizona, United States, 85032
      • Arizona Neuroscience Research LLC
  • California
    • Laguna Hills, California, United States, 92653
      • MS Center of California
    • Palo Alto, California, United States, 94304
      • Stanford Hospital and Clinics
    • San Francisco, California, United States, 94143
      • University of California San Francisco
    • San Francisco, California, United States, 94117
      • University of California San Francisco
  • Colorado
    • Aurora, Colorado, United States, 80045
      • University of Colorado - Anschutz Medical Campus (University of Colorado Health Sciences Center)
    • Fort Collins, Colorado, United States, 80528
      • Advanced Neurosciences Research LLC
  • Florida
    • Maitland, Florida, United States, 32751
      • Neurology Associates PA
    • Miami, Florida, United States, 33136
      • University of Miami
    • Orlando, Florida, United States, 32806
      • Neurological Services of Orlando
    • Tampa, Florida, United States, 33612
      • University of South Florida
    • Vero Beach, Florida, United States, 32860
      • Vero Beach Neurology and Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Atlanta NeuroScience Institute
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • Northbrook, Illinois, United States, 60062
      • Consultants in Neurology Ltd
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana Univ School of Med
  • Kansas
    • Kansas City, Kansas, United States, 66160
      • Kansas University Medical Center
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Hospital
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Henry Ford Hospital
    • Detroit, Michigan, United States, 48201
      • Wayne State University
    • Farmington Hills, Michigan, United States, 48334
      • Michigan Institute for Neurological Disorders
  • Minnesota
    • Golden Valley, Minnesota, United States, 55422
      • Minneapolis Clinic of Neurology
    • Minneapolis, Minnesota, United States, 55414
      • University of Minnesota
  • Missouri
    • St Louis, Missouri, United States, 63110
      • Washington University
  • Nebraska
    • Omaha, Nebraska, United States, 68198-8440
      • University of Nebraska Medical Center
  • New Jersey
    • Newark, New Jersey, United States, 07103
      • Rutgers New Jersey Medical School Department of Neurology
    • Teaneck, New Jersey, United States, 07666
      • Holy Name Hospital
  • New Mexico
    • Albuquerque, New Mexico, United States, 87131-0001
      • University of New Mexico
  • New York
    • Patchogue, New York, United States, 11772
      • South Shore Neurologic Associates PC
    • Stony Brook, New York, United States, 11790
      • SUNY at Stony Brook
  • North Carolina
    • Charlotte, North Carolina, United States, 28204
      • The Neurological Institute PA
    • Charlotte, North Carolina, United States, 28203
      • OnSite Clinical Solutions LLC
    • Charlotte, North Carolina, United States, 28207
      • Atrium Health
    • Raleigh, North Carolina, United States, 27607
      • Raleigh Neurology Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45267-0502
      • University Neurology Inc.
    • Westerville, Ohio, United States, 43082
      • Columbus Neuroscience
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104-5046
      • Oklahoma Medical Research Foundation
  • Oregon
    • Portland, Oregon, United States, 97225
      • Providence Neurological Specialties
  • Pennsylvania
    • Abington, Pennsylvania, United States, 19001
      • Abington Neurological Associates
  • Rhode Island
    • Providence, Rhode Island, United States, 02903
      • Rhode Island Hospital
  • Tennessee
    • Cordova, Tennessee, United States, 38018
      • Neurology Clinic PC
    • Knoxville, Tennessee, United States, 37934
      • Sibyl Wray MD Neurology PC
  • Texas
    • Houston, Texas, United States, 77030
      • Baylor College of Medicine
    • Houston, Texas, United States, 77054
      • Uni of Texas Health Science Center At Houston
    • Lubbock, Texas, United States, 79410
      • Bhupesh Dihenia M.D. P.A.
    • San Antonio, Texas, United States, 78258
      • Neurology Center of San Antonio
  • Vermont
    • Burlington, Vermont, United States, 05401
      • University of Vermont Medical Center
  • Washington
    • Seattle, Washington, United States, 98122-4470
      • Swedish Neuroscience Institute
    • Tacoma, Washington, United States, 98405
      • MultiCare Health System Institute for Research and Innovation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence and severity of adverse events, with severity determined according to the NCI CTCAE v5.0	Up to 44 months

Secondary Outcome Measures

Outcome Measure	Time Frame
Change in Expanded Disability Status Scale (EDSS) score over time	Week 0, 24, 48, 72, 96, 120, 168
Change in 9-Hole Peg Test (9HPT) over time	Week 0, 24, 48, 72, 96, 120, 168
Change in Timed 25-Foot Walk Test (T25FWT) over time	Week 0, 24, 48, 72, 96, 120, 168
The number of T1 lesions and number of new or enlarging T2 lesions	Week 0, 24, 48, 72, 96, 120, 168
The change in total volume of T2 lesions and in total non-enhancing T1 lesion volume	Week 0, 24, 48, 72, 96, 120, 168

Collaborators and Investigators

• Sponsor: Hoffmann-La Roche
• Investigators: Study Director: Clinical Trials, Hoffmann-La Roche

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2022
• Primary Completion (Estimated): December 31, 2027
• Study Completion (Estimated): December 31, 2027

Study Registration Dates

• First Submitted: February 11, 2022
• First Submitted That Met QC Criteria: March 4, 2022
• First Posted (Actual): March 7, 2022

Study Record Updates

• Last Update Posted (Actual): May 1, 2026
• Last Update Submitted That Met QC Criteria: April 30, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Nervous System Diseases; Autoimmune Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Multiple Sclerosis; Immunologic Factors; Physiological Effects of Drugs; ocrelizumab
• Other Study ID Numbers: MN43964; 2021-005746-15 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data_sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No