864
Participants
Start Date
November 26, 2020
Primary Completion Date
December 19, 2024
Study Completion Date
August 31, 2028
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.
Hospital Erasme, Brussels
S-Medicon Egeszsegugyi Szolgaltato Kft., Budapest
UNO Medical Trials Kft., Budapest
Rigshospitalet Glostrup, Glostrup Municipality
Inselspital Bern Medizin Neurologie, Bern
Austin Hospital, Heidelberg
Revalidatie en MS Centrum, Overpelt
Universitätsspital Basel Medizin Neurologie, Basel
Ospedale Regionale di Lugano - Civico, Lugano
Somogy Vármegyei Kaposi Mór Oktató Kórház, Kaposvár
Hospital Puerta del Mar, Cadiz
401 Military Hospital of Athens, Athens
Charite - Universitätsmedizin Berlin, Berlin
Mun.Med.Proph.Inst.?Chernihiv Reg.Hosp.?, Chernihiv
Dent Neurological Institute, Amherst
Clinica Internacional, Lima
Complejo Hospitalario Universitario A Coruña (CHUAC), A Coruña
5th Cherkasy City Center of Primary Health Care, Cherkasy
Abington Neurological Associates, Willow Grove
Fond. Istituto Neurologico C.Besta, Milan
Universitätsklinikum Schleswig-Holstein, Kiel
Hospital Quiron de Madrid, Pozuelo de Alarcón
Hospital Regional Universitario de Malaga ? Hospital General, Málaga
Neurology Associates, PA, Maitland
Groupe Hospitalier Pellegrin, Bordeaux
University of South Florida, Tampa
North Central Neurology Associates, Cullman
Alabama Neurology Associates, Homewood
Tri-State Mountain Neurology, Johnson City
Hope Neurology, Knoxville
Kocaeli University Hospital, Kocaeli
St. Josef-Hospital, Klinik für Neurologie, Bochum
UC Health Neurology, Dayton
American Health Network Institute, LLC, Avon
Henry Ford Health System, Detroit
SI USSRI of Medical and Social Problems of Disabilities of MOHU, Dnipro
Bukovinsky SMU RMI Chernivtsi RCH, Chernivtsi
CH St Vincent de Paul, Lille
Municipal Nonprofit Enterprise of Kharkiv Regional Council Regional Clinical Hospital, Kharkiv
St.In.Inst. of Neurol.Psych.and Narcol.of the AMSU, Kharkiv
CHU Hopital Gabriel Montpied, Clermont-Ferrand
Washington University School of Medicine, St Louis
Deutsche Klinik für Diagnostik, Wiesbaden
Universita? G. D'Annunzio, Chieti
University of Kansas Medical Center, Kansas City
"LCC Medical center Unimed", Zaporizhzhia
Municipal Non-profit Enterprise Zaporizhzhya Regional Hospital Zaporizhzhya Regional Council, Zaporizhzhia
The NeuroMedical Clinic of Central Louisiana, Alexandria
Universitätsklinikum Tübingen, Zentrum für Neurologie, Tübingen
Oklahoma Medical Research Foundation, Oklahoma City
Regional Clinical Hospital, Ivano-Frankivsk
Hôpital Charles Nicolle, Rouen
Lone Star Neurology of San Antonio, San Antonio
Lvivska oblasna tsentralna likarnia, Lviv
Bhupesh Dihenia M.D. P.A., Lubbock
AOU Seconda Università degli Studi, Napoli
AOU Seconda Università degli Studi, Napoli
Advanced Neurology of Colorado, LLC, Fort Collins
21st Century Neurology, Phoenix
IRCCS Istituto Neurologico Neuromed, Pozzilli
Universitätsklinikum Ulm, Ulm
Cleveland Clinic Lou Ruvo, Las Vegas
Profound Research, LLC, Carlsbad
Stanford University Medical Center, Stanford
Evergreen MS Center, Kirkland
Neiro Clinica LLC, Moscow
Federal center of brain research and neurotechnologies, Moskva
Research Center of Neurology of RAMS, Moscow
City Clinical Hospital #24, Moskva
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
Saratov State Medical University of RosZdrav, Saratov
Vertebronevrologiya LLC, Kazan'
KSMU Interregional Clinical Diagnostic Centre, Kazan'
Ulyanovsk Regional Clinical Hospital, Ulyanovsk
SHI Sverdlovsk Regional Clinical Hospital #1, Yekaterinburg
Nebbiolo Center for Clinical Trials, Tomsk
FSBHI Siberian Clinical Center of the Federal Medical and Biological Agency, Krasnoyarsk
Maine Medical Center, Scarborough
Dragonfly Research, LLC, Wellesley
Centro de Especialidades Neurológicas y Rehabilitación - CENyR, Buenos Aires
CEMIC, Buenos Aires
Centro de Investigaciones Médicas Tucuman, San Miguel de Tucumán
Instituto de Neurologia de Curitiba, Curitiba
IMV Pesquisa Neurológica, Porto Alegre
Clinica Neurologica, Joinville
CPQuali Pesquisa Clinica Ltda, São Paulo
Recherche Sepmus Inc., Greenfield Park
Hotel-Dieu de Levis, Lévis
"Universitätsklinikum Carl Gustav Carus, Zentrum für Klinische Neurowissenschaften", Dresden
Universität Leipzig, Leipzig
Policlinico Tor Vergata Dip. Neuroscienze-Clinica Neurologica-UOSD Sclerosi Multipla, Rome
NCL Institute Neuroscience, Rome
Policlinico Umberto I, Rome
Hospital IV Alberto Sabogal Sologuren, Bellavista
Instituto Nacional de Ciencias Neurológicas - Hospital Mogrovejo, Lima
Hospital Maria Auxiliadora, Lima
Hospital Nacional Dos de Mayo, Lima
Hospital Alvaro Cunqueiro, Vigo
Clinica Sanchez Ferrer, Trujillo
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
SPZOZ Uniwersytecki Szp. Klin. nr1 im.N.Barlickiego UM, Lodz
Centrum Neurologii Krzysztof Selmaj, Lodz
Indywidualna Praktyka Lekarska Prof. Dr Hab. N. Med. Konrad Rejdak., Lublin
Neurologiczny Niepubliczny ZOZ Centrum Leczenia SM Osrodek Bada? Klinicznych, Plewiska
EMC Instytut Medyczny SA, Późna
Nmedis sp. z o.o., Rzeszów
Osrodek Badan Klinicznych Euromedis, Szczecin
Centrum Medyczne NeuroProtect, Warsaw
Klinika Neurologii I Wydzialu Lekarskiego WUM w Warszawie, Warsaw
Instytut Psychiatrii i Neurologii II Klinika Neurologiczna, Warsaw
Wojskowy Instytut Medyczny - Pa?Stwowy Instytut Badawczy, Warsaw
Hospital de Braga, Braga
Centro Hospitalar de Lisboa Ocidental - Hospital Egas Moniz, Lisbon
Hospital de Santa Maria, Lisbon
Hospital Universitari Vall d'Hebron, Barcelona
Medical Center of Private Execution First Private Clinic, Kyiv
Medical Center Dopomoga Plus, Kyiv
Derriford Hospital, Plymouth
Hoffmann-La Roche
INDUSTRY