769
Participants
Start Date
December 3, 2020
Primary Completion Date
June 30, 2025
Study Completion Date
September 8, 2027
Ocrelizumab
"The actual higher dose of ocrelizumab will be assigned to participants based on their body weight at baseline: 1200 mg (body weight \<75 kg) or 1800 mg (body weight ≥ 75 kg). The first dose of ocrelizumab will be administered as two 600 mg or 900 mg IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 1200 mg or 1800 mg IV infusion Q24W.~During the optional OLE phase, participants will continue with their assigned dose of ocrelizumab (either 1200 or 1800 mg) for approximately 96 weeks (4 doses in total)"
Ocrelizumab
Ocrelizumab will be administered at a dose of 600 mg Q24W. The first dose of ocrelizumab will be administered as two 300 mg, IV infusions given 14 days apart. For the subsequent doses, ocrelizumab will be administered as a single 600 mg IV infusion Q24W.
Antihistamine
Premedication with oral or IV antihistaminic drug (i.e., diphenhydramine 50 mg or an equivalent dose of an alternative) will be administered prior to each ocrelizumab infusion.
Methylprednisolone
Premedication with 100 mg of methylprednisolone (or equivalent) will be administered by IV infusion prior to each ocrelizumab infusion.
MHATNP Sveti Naum EAD, Sofia
Semmelweis Egyetem Idegsebeszeti és Neurointervencios Klinika, Budapest
UNO Medical Trials Kft., Budapest
CEMIC Saavedra, Buenos Aires
Kistarcsai Flor Ferenc Korhaz, Kistarcsa
Rigshospitalet Glostrup, Glostrup Municipality
Inselspital Bern Medizin Neurologie, Bern
Revalidatie en MS Centrum, Overpelt
UMHAT Dr. Georgi Stranski, Pleven
Somogy Megyei Kaposi Mor Oktato Korhaz, Kaposvár
Aalborg Universitetshospital, Aalborg
Petz Aladar Megyei Oktato Korhaz, Győr
Lenox Hill Hospital, New York
AOU Città della Salute e della Scienza, Turin
Northwell Health, Great Neck
401 Military Hospital of Athens, Athens
Hopital Cote De Nacre, Caen
Universitätsmedizin Greifswald, Greifswald
5th Cherkasy City Center of Primary Health Care, Cherkasy
IRCCS Ospedale San Raffaele, Milan
Medical Clinical Research Center of Medical Center LLC Health Clinic, Vinnytsi
Ospedale S.Antonio Abate, Gallarate
International Neurorehabilitation Institute, Lutherville
CHU de Besancon Hopital Jean Minjoz, Besançon
IRCCS Istituto Neurologico C. Mondino?Dip. Neurologia Neuroriabilitazione S.S. Sclerosi Multipla, Pavia
Hospital Universitario Puerta De Hierro Majadahonda, Madrid
Hospital Quiron de Madrid, Pozuelo de Alarcón
CHU Brest Hopital La Cavale Blanche, Brest
Medizinische Hochschule Hannover, Klinik für Neurologie, Hanover
Mersin University Medical Faculty, Mersin
University of South Florida, Tampa
MS and Neuromuscular Center of Excellence, Clearwater
Haseki Training and Research Hospital, Istanbul
Istanbul Universitesi - Cerrahpasa Cerrahpasa Tip Fakultesi, Istanbul
Sancaktepe Training and Research Hospital, Istanbul
Ege Üniversitesi Tip Fakültesi, Lzmir
Alabama Neurology Associates, Homewood
Advanced Neurosciences Institute, Nashville
Neurology Clinic PC, Cordova
Erciyes Universitesi, Kayseri
Sumy Regional Clinical Hospital, Sumy
Baptist Health Lexington, Nicholasville
Kocaeli University Hospital, Kocaeli
Selcuk University Medical Faculty, Istanbul
Volyn Regional Clinical Hospital, Lutsk
Centro de Investigacion Medico Biologico y Terapia Avanzada, S.C., Guadalajara
Cleveland Clinic, Cleveland
Universitätsklinikum Münster, Münster
Michigan Institute for Neurological Disorders, Farmington Hills
SI USSRI of Medical and Social Problems of Disabilities of MOHU, Dnipro
Wheaton Franciscan Healthcare - St. Francis Outpatient Center, Milwaukee
Hopital Central - CHU de Nancy, Nancy
Ondokuz Mayis University School of Medicine, Samsun
Cumhuriyet Universitesi Tip Fakultesi, Merkez
CH St Vincent de Paul, Lille
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU, Kharkiv
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Kharkiv
CHU Hopital Gabriel Montpied, Clermont-Ferrand
Washington University School of Medicine, St Louis
Deutsche Klinik für Diagnostik, Wiesbaden
Hopital Hautepierre - CHU Strasbourg, Strasbourg
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council, Zaporizhzhia
Universitätsklinikum Tübingen, Zentrum für Neurologie, Tübingen
Texas Institute for Neurological Disorders, Sherman
University of Texas Southwestern Medical Center, Dallas
Regional Clinical Hospital, Ivano-Frankivsk
Neurociencias Prisma, A.C, San Luis Potosí City
Lone Star Neurology of San Antonio, San Antonio
Lvivska oblasna tsentralna likarnia, Lviv
University of Colorado Denver, Aurora
A. O. U. Federico II, Napoli
AOU Seconda Università degli Studi, Napoli
Advanced Neurosciences Research LLC, Fort Collins
21st Century Neurology, Phoenix
Universitätsklinikum Ulm, Ulm
University of California Irvine, Irvine
Stanford University Medical Center, Stanford
Federal center of brain research and neurotechnologies, Moskva
Research Center of Neurology of RAMS, Moscow
City Clinical Hospital #24, Moskva
Leningrad Regional Clinical Hospital, Saint Petersburg
National Center of Social Significant Disease, Saint Petersburg
N.P. Bechtereva Institute of the Human Brain, Saint Petersburg
City Hospital #40 of Kurortniy Administrative District, Saint Petersburg
Regional clinical hospital named after prof. S.V. Ochapovsky, Krasnodar
Vertebronevrologiya LLC, Kazan'
Ulyanovsk Regional Clinical Hospital, Ulyanovsk
Center of Cardiology and Neurology, Kirov
Perm SMA n.a. academ. E.A. Vagner, Perm
SHI Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg
FSBIH Siberian Regional Medical Centre of FMBA of Russia, Novosibirsk
Krasnoyarsk State Medical Academy, Krasnoyarsk
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency, Krasnoyarsk
Massachusetts General Hospital., Boston
University of Massachusetts Medical School, Worcester
Jersey Shore University Medical Centre, Neptune City
Centro de Especialidades Neurológicas y Rehabilitación - CENyR, Buenos Aires
INECO, Rosario
L2 Ip Instituto de Pesquisas Clinicas Ltda ME, Brasília
Hospital das Clinicas - UFG, Goiânia
Instituto de Neurologia de Curitiba, Curitiba
Instituto Méderi de Pesquisa e Saúde, Passo Fundo
Hospital Moinhos de Vento, Porto Alegre
IMV Pesquisa Neurológica, Porto Alegre
Hospital Sao Lucas - PUCRS, Porto Alegre
Clinica Neurologica, Joinville
Hospital das Clinicas - UNICAMP, Campinas
Praxis Pesquisa Médica, Santo André
CPQuali Pesquisa Clinica Ltda, São Paulo
Chum Campus Notre Dame, Montreal
MUCH - Montreal Neurological Institute & Hospital, Montreal
Hotel-Dieu de Levis, Québec
"Universitätsklinikum Carl Gustav Carus, Zentrum für Klinische Neurowissenschaften", Dresden
Universität Leipzig, Leipzig
Hospital Eginition, Athens
Azienda Ospedaliera Sant'Andrea, Rome
Clinstile S.A de C.V., Mexico City
Grupo Médico Camino S.C., México
Hospital Nacional Guillermo Almenara Irigoyen, La Victoria, Lima
Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo, Lima
Hospital Nacional Dos de Mayo, Lima
Hospital Universitario Virgen de Arrixaca, Murcia
Neurocentrum Bydgoszcz sp. z o.o, Bydgoszcz
COPERNICUS Podmiot Leczniczy Sp. z o. o. Szpital im. M. Kopernika, Gdansk
MA-LEK Clinical Sp. Z o.o., Katowice
Szpital Specjalistyczny im. Rydygiera w Krakowie, Krakow
Centrum Neurologii Krzysztof Selmaj, Lodz
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak., Lublin
Instytut Zdrowia Dr Boczarska-Jedynak Sp. z o.o. Sp. k., Oświęcim
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych, Plewiska
EMC Instytut Medyczny SA, Późna
Wojewódzki Szpital Specjalistyczny Nr 3, Rybnik
Nmedis sp. z o.o., Rzeszów
Osrodek Badan Klinicznych Euromedis, Szczecin
Centrum Medyczne NeuroProtect, Warsaw
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna, Warsaw
Hospital de Braga, Braga
Hospital Santo Antonio dos Capuchos, Lisbon
Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz, Lisbon
Hospital Geral de Santo Antonio, Porto
Hospital Universitari Vall d'Hebron, Barcelona
Gazi University Medical Faculty, Ankara
Baskent Universitesi Ankara Hastanesi, Çankaya
Medical Center Dopomoga Plus, Kyiv
Medical Center of Private Execution First Private Clinic, Kyiv
Charing Cross Hospital, London
National Hospital for Neurology and Neurosurgery,, London
Royal Victoria Infirmary, Newcastle upon Tyne
Derriford Hospital, Plymouth
Hoffmann-La Roche
INDUSTRY