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 Contact: Name: Reference Study ID Number: MN43964, https://forpatients.roche.com/; Phone Number: 888-662-6728 (U.S.); Email: global-roche-genentech-trials@gene.com

Study Locations

• Argentina
  • Ciudad Autonoma Bs As, Argentina, C1209AAB
    • Hospital Español
  • Rosario, Argentina, S2000BZL
    • Fundacion Rosarina de Neurorehabilitacion
• Australia
  • New South Wales
    • St. Leonards, New South Wales, Australia, 2065
      • Royal North Shore Hospital
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • St Vincent's Hospital Melbourne
• Austria
  • Innsbruck, Austria, 6020
    • Medizinische Universitat Innsbruck
  • Linz, Austria, 4040
    • Barmherzige Brueder Konventspital
  • Wien, Austria, 1090
    • AKH - Medizinische Universität Wien; Neurology
• Belarus
  • Minsk, Belarus, 2200045
    • State Institution Minsk Research and Practice Center of Surgery Transplantation and Hematology
  • Brestskaya Voblasts'
    • Grodno, Brestskaya Voblasts', Belarus, 230017
      • Grodno University Hospital
  • Vitsyebskaya Voblasts'
    • Vitebsk, Vitsyebskaya Voblasts', Belarus, 210037
      • Vitebsk Regional Clinical Hospital
• Belgium
  • Brugge, Belgium, 8000
    • AZ Sint Jan
  • Bruxelles, Belgium, 1200
    • Cliniques Universitaires Saint-Luc
  • Edegem, Belgium, 2650
    • UZA
  • Eeklo, Belgium, 9900
    • Algemeen Ziekenhuis Alma
  • Roeselare, Belgium, 8800
    • AZ Delta Campus Westlaan
• Brazil
  • AP
    • Joinville, AP, Brazil, 89202-165
      • Clinica Neurologica e Neurocirurgica de Joinville
  • BA
    • Rio de Janeiro, BA, Brazil, 21941-913
      • HUCFF-UFRJ - Hospital Universitário Clementino Fraga Filho Universidade Federal do Rio de Janeiro
  • RJ
    • Porto Alegre, RJ, Brazil, 90110-000
      • IMV Pesquisa Neurologica Sociedade Simples Ltda
    • Rio de Janeiro, RJ, Brazil, 20270-004
      • Hospital Universitario Gaffree e Guinle; Neurologia
  • RS
    • Porto Alegre, RS, Brazil, 90610-000
      • Hospital Sao Lucas da PUCRS*X
  • SP
    • Campinas, SP, Brazil, 13083-888
      • HC-UFG - Hospital das Clínicas da Universidade Federal de Goiás
• 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; Department of Rheumatology
• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2N 2T9
      • Calgary MS Clinic
    • Edmonton, Alberta, Canada, T6G 2C8
      • University of Alberta; Northern Alberta Trials & Research Centre
  • 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; Hematology and Oncology
  • 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; Pharmacy Department
• Croatia
  • Varazdin, Croatia, 42000
    • General Hospital Varazdin
  • Zagreb, Croatia, 10000
    • University hospital center Zagreb
• Czechia
  • Brno, Czechia, 613 00
    • Fakultni nemocnice Brno
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne
  • Havirov, Czechia, 736 00
    • Neurospol s.r.o.
  • Hradec Kralove, Czechia, 500 05
    • Fakultni nemocnice Hradec Kralove
  • Jihlava, Czechia, 586 33
    • Nemocnice Jihlava
  • Pardubice, Czechia, 532 03
    • Pardubicka krajska nemocnice a.s.
  • Praha 2, Czechia, 128 08
    • Vseobecna fakultni nemocnice v Praze
  • Teplice, Czechia, 415 29
    • Krajska zdravotni a.s. - Nemocnice Teplice o.z.
• Estonia
  • Tallinn, Estonia, 10617
    • West Tallinn Central Hospital
  • Tartu, Estonia, 51014
    • Tartu University Hospital
• Finland
  • Tampere, Finland, 33200
    • Tammer Tutka Oy
• France
  • Bordeaux, France, 33000
    • Groupe Hospitalier Pellegrin
  • Bron, France, 69500
    • Hôpital Neurologique Pierre Wertheimer
  • Caen, France, 14033
    • CHU de Caen Hôpital Cote de Nacre
  • Clermont Ferrand, France, 63003
    • CHU Hôpital Gabriel Montpied
  • Lille, France
    • Hopital Roger Salengro Service de Neurologie
  • Nancy, France, 54035
    • CHU Nancy Hôpital Central
  • Nantes, France, 44093
    • CHU Nantes Hopital Nord Laënnec; Pharmacy
  • Nice, France, 06000
    • CHU Nice - Hôpital Pasteur 2
  • Poissy, France, 78300
    • Centre Hospitalier Intercommunal de Poissy
  • Strasbourg, France, 67098
    • CHU Strasbourg Hôpital Hautepierre
• Germany
  • Bayreuth, Germany, 95445
    • Klinikum Bayreuth Standort Hohe Warte Klinik fur Neurologie; Klinik für Neurologie
  • Berlin, Germany, 13347
    • Jüdisches Krankenhaus Berlin; Abteilung fur Neurologie
  • Berlin, Germany, 10117
    • Charité Universitaetsmedizin Berlin - Campus Ch
  • Bonn, Germany, 53111
    • Neurologie in Bonn
  • Dresden, Germany, 01307
    • Universitaetsklinikum Carl Gustav Carus TU Dresden
  • Dusseldorf, Germany, 40225
    • Universitaetsklinikum Duesseldorf
  • Essen, Germany, 45138
    • Zentrum fuer ambulante Neurologie
  • Frankfurt, Germany, 60590
    • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Gießen, Germany, 35392
    • Universitaetsklinikum Giessen und Marburg GmbH; Zytostatikaabteilung
  • Leipzig, Germany, 04103
    • Universitaetsklinikum Leipzig
  • Mittweida, Germany, 09648
    • Pharmakologisches Studienzentrum
  • Muenster, Germany, 48149
    • Universitaetsklinikum Muenster
  • München, Germany, 81675
    • Klinikum rechts der Isar der TU Muenchen
  • Prien, Germany, 83209
    • Neurozentrum Prien
  • Regensburg, Germany, 93053
    • Medizinische Einrichtungen des Bezirks Oberpfalz GmbH
  • Tuebingen, Germany, 72076
    • Universitaetsklinikum Tuebingen
  • Ulm, Germany, 89081
    • Universitätsklinikum Ulm; Klinik für Neurologie
  • Ulm, Germany, 89073
    • NeuroPoint Gesellschaft fur vorbeugende Gesundheitspflege mbH
  • Westerstede, Germany, 26655
    • Studienzentrum Nordwest Dr med Joachim Springub Herr Wolfgang Schwarz
• Hungary
  • Budapest, Hungary, 1204
    • Jahn Ferenc Del-pesti Korhaz es Rendelointezet
  • Budapest, Hungary, 1138
    • S-Medicon Egeszsegugyi Szolgaltato Kft.
  • Pecs, Hungary, 7624
    • Pecsi Tudomanyegyetem
  • Szeged, Hungary, 6720
    • Szegedi Tudományegyetem Szent-Györgyi Albert Klinikai Központ
• Israel
  • Jerusalem, Israel, 9112001
    • Hadassah University Hospital - Ein Kerem
  • Petach Tiqwa, Israel, 49100
    • Rabin Medical Center Beilinson Campus; Gaucher Clinic Genetics Institute
  • Ramat Gan, Israel, 5266202
    • Chaim Sheba Medical Center
  • Ramat-Gan, Israel, 5262000
    • Chaim Sheba Medical Center; Neurology Department
  • Tel Aviv, Israel, 6423906
    • Tel Aviv Sourasky Medical Center; Department of Neurology
• Italy
  • Lazio
    • Roma, Lazio, Italy, 00133
      • Azienda Ospedaliera Universitaria Policlinico Tor Vergata
    • Roma, Lazio, Italy, 189
      • Azienda Ospedaliera Sant'Andrea-Universitr di Roma La Sapien
  • Liguria
    • Genova, Liguria, Italy, 16132
      • Ospedale Policlinico San Martino
  • Lombardia
    • Brescia, Lombardia, Italy, 25100
      • Azienda Socio Sanitaria Territoriale degli Spedali Civili di Brescia (Presidio Spedali Civili)
    • Milano, Lombardia, Italy, 20133
      • Fondazione IRCCS Istituto Neurologico Carlo Besta
    • Milano, Lombardia, Italy, 20132
      • Hospital San Raffaele
  • Marche
    • Torrette Di Ancona, Marche, Italy, 60126
      • Azienda Ospedaliero Universitaria Ospedali Riuniti
  • Piemonte
    • Orbassano, Piemonte, Italy, 10043
      • Azienda Sanitaria Ospedaliera S Luigi Gonzaga
    • Ponderano, Piemonte, Italy, 13875
      • Ospedale Degli Infermi
  • Sicilia
    • Cefalù, Sicilia, Italy, 90015
      • Fondazione Istituto G. Giglio di Cefalù
  • Valle D?Aosta
    • Gallarate, Valle D?Aosta, Italy, 21013
      • Azienda Socio Sanitaria Territoriale della Valle Olona (pres
• Latvia
  • R?ga, 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, 50009
    • Hospital of Lithuanian University of Health Sciences Kaunas Clinics Public Institution
  • Klaipeda, Lithuania, 92288
    • Klaipeda University Hospital Public Institution
  • Vilnius, Lithuania, 8406
    • Vilnius University hospital Santaros klinikos
• Mexico
  • Aguascalientes, Mexico, 20010
    • Investigacion Biomedica para el Desarrollo de Farmacos S.A. de C.V. Aguascalientes
  • Chihuahua, Mexico, 31238
    • Hospital Angeles Chihuahua
  • Mexico CITY (federal District)
    • Ciudad de México, Mexico CITY (federal District), Mexico, 03100
      • Mexico Centre for Clinical Research
    • DF, Mexico CITY (federal District), Mexico
      • Grupo Medico Camino
    • Guadalajara, Mexico CITY (federal District), Mexico, 44610
      • Hospital Mexico Americano
    • Tlalnepantla de Baz, Mexico CITY (federal District), Mexico, 54055
      • Clinical Research Institute
  • Nuevo LEON
    • Monterrey, Nuevo LEON, Mexico, 64460
      • Hospital Universitario Dr Jose Eleuterio Gonzalez; Universidad Autónoma de Nuevo León
    • Monterrey, Nuevo LEON, Mexico, 64620
      • Centro de Estudios Clinicos y Especialidades Medicas S C
  • Sinaloa
    • Culiacan, Sinaloa, Mexico, 80020
      • Hospital Angeles Culiacan
• Netherlands
  • Sittard-Geleen, Netherlands, 6162 BG
    • Zuyderland Medisch Centrum - Sittard-Geleen'
• New Zealand
  • Hamilton, New Zealand, 3248
    • Waikato Hospital
• Norway
  • Bergen, Norway, 5053
    • Haukeland Universitetssykehus
• Poland
  • Bydgoszcz, Poland, 85-079
    • NZOZ Vitamed
  • Gda?sk, Poland, 80-803
    • COPERNICUS Podmiot Leczniczy Sp z o o
  • Katowice, Poland, 40-588
    • Specjal. Praktyka Lekarska; Prof. Grzegorz Opala
  • Katowice, Poland, 40-571
    • M.A. LEK A.M.Maciejowscy SC.
  • Katowice, Poland, 40-686
    • Neuro-Medic Janusz Zbrojkiewicz
  • Krakow, Poland, 31-505
    • Centrum Neurologii Klinicznej
  • 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
  • Warszawa, Poland, 01-684
    • Centrum Medyczne NeuroProtect
• Portugal
  • Almada, Portugal, 2801-951
    • Hospital Garcia de Orta; Servico de Neurologia
  • Braga, Portugal, 4710-243
    • Hospital de Braga
  • Coimbra, Portugal, 3041-801
    • Centro Hospitalar E Universitário de Coimbra EPE
  • Lisboa, Portugal, 1649-035
    • Centro Hospitalar de Lisboa Norte, EPE - Hospital Santa Maria
• Romania
  • Bucuresti, Romania, 011461
    • Spitalul Universitar de Urgenta Elias; Oncologie Medicala
  • Campulung, Romania, 115100
    • SC Clubul Sanatatii SRL
• Russian Federation
  • Kemerovo, Russian Federation, 650066
    • SAIH "Kemerovo Regional Clinical Hospital"
  • Kirov, Russian Federation, 610014
    • Kirov RSBIH "Kirov City Clinical Hospital # 1"
  • Novosibirsk, Russian Federation, 630007
    • FSBIH Siberian Clinical Center of FMBA of Novosibirsk
  • Perm, Russian Federation, 614990
    • Perm SMA n.a. academ. E.A. Vagner
  • Samara, Russian Federation, 443095
    • SBEI HPE "Samara State Medical University" of the MoH of the RF
  • Smolensk, Russian Federation, 214018
    • RSBIH "Smolensk Regional Clinical Hospital"
  • Stavropol, Russian Federation, 355017
    • Saratov State Medical University
  • Altaj
    • Barnaul, Altaj, Russian Federation, 656043
      • Siberian Medical Center
  • Mordovija
    • Saransk, Mordovija, Russian Federation, 430032
      • SBIH of Republic Mordoviya "Republican Clinical Hospital # 4"
  • Moskovskaja Oblast
    • Moskva, Moskovskaja Oblast, Russian Federation, 115682
      • FGBU FNKC FMBA of Russia
    • Moskva, Moskovskaja Oblast, Russian Federation, 129128
      • SBIH City Polyclinic 2 of the Department of Health of the City of Moscow
  • Niznij Novgorod
    • Nizhny Novgorod, Niznij Novgorod, Russian Federation, 603155
      • SBIH of Nizhniy Novgorod region "City Clinical Hospital # 3"
  • Sankt Petersburg
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 194044
      • FSBMEI HPE "Military Medical Academy n.a. S.M. Kirov" of the MoD of the RF
    • Sankt-peterburg, Sankt Petersburg, Russian Federation, 194354
      • SPb SBIH "City Multy-field Hospital # 2"; Intensive Pulmonology and Thoracal Surgery
    • St. Petersburg, Sankt Petersburg, Russian Federation, 197022
      • Pavlov First Saint Petersburg State Medical University
  • Stavropol
    • Pyatigorsk, Stavropol, Russian Federation, 357538
      • SBIH of Stavropol territory " City Hospital # 2" of Pyatigorsk; Neurology Department
  • Sverdlovsk
    • Yekaterinburg, Sverdlovsk, Russian Federation, 620102
      • Sverdlovsk Regional Clinical Hospital 1
  • Tjumen
    • Tyumen, Tjumen, Russian Federation, 625048
      • Regional Multiple Sclerosis Centre b/o CC ECM Neftyanik; Neurology
  • Vologda
    • Kazan, Vologda, Russian Federation, 420101
      • SAHI "Interregional Clinical and Diagnostic Center"
• Serbia
  • Kragujevac, Serbia, 34000
    • Clinical Center Kragujevac
  • NIS, Serbia, 18000
    • Clinical Center Nis
• Slovakia
  • Banska Bystrica, Slovakia, 974 04
    • MUDr. Beata Dupejova Neurologicka ambulancia s.r.o
  • Bratislava, Slovakia, 826 06
    • Univerzitna nemocnica Bratislava Nemocnica Ruzinov
  • Zilina, Slovakia, 012 07
    • Fakultna nemocnica s poliklinikou Zilina
• Spain
  • Barcelona, Spain, 08035
    • Hospital Vall d'Hebron; Servicio de Neurología
  • Madrid, Spain, 28034
    • Hospital Universitario Ramon y Cajal
  • Madrid, Spain, 28006
    • Hospital Universitario de la Princesa; Servicio de Neurologia
  • Madrid, Spain, 28040
    • Hospital Universitario Clínico San Carlos; Servicio de Neurología
  • Malaga, Spain, 29010
    • Hospital Regional Universitario de Málaga
  • Barcelona
    • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
      • Hospital Universitari de Bellvitge; Servicio de Neurologia
  • Girona
    • Salt, Girona, Spain, 17190
      • Hospital Santa Caterina
  • LA Coruña
    • Santiago de Compostela, LA Coruña, Spain, 15706
      • Complejo Hospitalario Universitario de Santiago (CHUS) Servicio de Neurologia
  • Madrid
    • Majadahonda, Madrid, Spain, 28220
      • Hospital Universitario Puerta de Hierro - Majadahonda
  • Sevilla
    • Seville, Sevilla, Spain, 41071
      • Hospital Universitario Virgen Macarena
  • Vizcaya
    • Bilbao, Vizcaya, Spain, 48013
      • Hospital de Basurto Servicio de Neurologia
• Sweden
  • Mölnlycke, Sweden, 435 33
    • Sahlgrenska Sjukhuset
  • Solna, Sweden, 171 64
    • Akademiskt Specialist Centrum
  • Stockholm, Sweden, 171 64
    • Karolinska Universitetssjukhuset Huddinge
• Switzerland
  • Basel, Switzerland, 4031
    • Universitaetsspital Basel
  • Lugano, Switzerland, 6900
    • Ospedale Regionale di Lugano
• Tunisia
  • Mannouba, Tunisia, 2010
    • Hopital Razi
  • Monastir, Tunisia, 5000
    • Hopital Universitaire Fattouma Bourguiba
• Turkey
  • Istanbul, Turkey, 34000
    • Istanbul University Cerrahpasa Medical Faculty
  • Samsun, Turkey, 55139
    • Ondokuz Mayis Univ. Med. Fac.; Neurology
  • Trabzon, Turkey, 61080
    • Karadeniz Tecnical Uni. Med. Fac
• Ukraine
  • Chernihiv Governorate
    • Vinnytsia, Chernihiv Governorate, Ukraine, 21050
      • Medical Center of Limited Liability Company Medical Center Saliutem
  • KIEV Governorate
    • Chernihiv, KIEV Governorate, Ukraine, 14029
      • CMPI Chernihiv Regional Hospital; Reg.Cen.for Inflam.&demyelin.dis.of the CNS
    • Dnipro, KIEV Governorate, Ukraine, 49005
      • CE I.I.Mechnykov Dnipropetrovsk RC Hosp Dept of Neurology DSMU
    • Ivano Frankivsk, KIEV Governorate, Ukraine, 76008
      • CNE Regional Clinical Hospital of Ivano-Frankivsk Regional Council
    • 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
    • Kyiv, Kharkiv Governorate, Ukraine, 03037
      • Medical Center of Limited Liability Company Medbud-Clinic
    • 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 2ES
    • Barts Health NHS Trust
  • Newcastle upon Tyne, United Kingdom, NE1 4LP
    • Royal Victoria Infirmary
  • Nottingham, United Kingdom, NG7 2UH
    • Nottingham University Hospitals Queen's Medical Centre
  • Swansea, United Kingdom, SA6 6NL
    • Morriston Hospital
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85013
      • Barrow Neurological Institute
    • Phoenix, Arizona, United States, 85032-2181
      • Arizona Neuroscience Research LLC
  • California
    • Laguna Hills, California, United States, 92653
      • MS Center of California
    • Long Beach, California, United States, 90806
      • Collaborative Neuroscience Research, LLC
    • Palo Alto, California, United States, 94304
      • Stanford Hospital and Clinics
    • 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
    • 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, 32960
      • Vero Beach Neurology and Research Institute
  • Georgia
    • Atlanta, Georgia, United States, 30327
      • Atlanta Neuroscience Institute
  • Illinois
    • Chicago, Illinois, United States, 60611-2987
      • 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, 66103
      • 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; Clin. Neuro Research Unit
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • Washington University
  • Nebraska
    • Omaha, Nebraska, United States, 68198-0600
      • 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
      • 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, 28277
      • OnSite Clinical Solutions LLC
    • Charlotte, North Carolina, United States, 28204
      • The Neurological Institute PA
    • Charlotte, North Carolina, United States, 28209
      • Atrium Health
    • Hickory, North Carolina, United States, 28602
      • Neurology Associates PA
    • Raleigh, North Carolina, United States, 27607-6520
      • Raleigh Neurology Associates
  • Ohio
    • Cincinnati, Ohio, United States, 45219
      • University Neurology Inc.
    • Columbus, Ohio, United States, 43801
      • Columbus Neuroscience
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73104
      • 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, 77030
      • Uni of Texas Health Science Center At Houston
    • Lubbock, Texas, United States, 79410
      • Bhupesh Dihenia M.D. P.A.
    • Round Rock, Texas, United States, 78681
      • Central Texas Neurology Consultants
    • San Antonio, Texas, United States, 78258
      • Neurology Center of San Antonio
  • Vermont
    • Burlington, Vermont, United States, 05405
      • University of Vermont Medical Center; Neurology
  • Washington
    • Seattle, Washington, United States, 98122
      • 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, 2025
• Study Completion (Estimated): December 31, 2025

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 (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis; Physiological Effects of Drugs; Immunologic Factors; 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: Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm

Drug and device information, study documents

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