188
Participants
Start Date
May 19, 2022
Primary Completion Date
June 9, 2025
Study Completion Date
September 17, 2029
Ocrelizumab
Ocrelizumab 300 milligrams (mg) will be administered by IV infusion to participants who weigh \< 35 kilograms (kg) and ocrelizumab 600 mg IV will be administered to participants who weigh ≥ 35 kg on Days 1 and 15 (half the dose, 2 weeks apart) and Q24W thereafter.
Ocrelizumab Placebo
Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter.
Fingolimod
Fingolimod will be administered daily as a capsule per the prescribing information (0.25 mg to participants who weigh ≤ 40 kg and 0.5 mg to participants who weigh \> 40 kg).
Fingolimod Placebo
Fingolimod matching placebo will be administered daily as a capsule.
Hôpital Universitaire des Enfants Reine Fabiola, Brussels
Medizinische Universität Wien, Vienna
Semmelweis Egyetem, Budapest
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan, Ciudad de Buenos Aires
Cliniques Universitaires St-Luc, Brussels
Royal Children's Hospital Melbourne - PIN, Parkville
Grupo Médico Camino S.C., Mexico City
Universitäts-Kinderspital Zürich - Eleonorenstiftung, Zurich
UZ Gent, Ghent
Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites, Rabat
Hospital Militaire Dinstruction Mohammed V de Rabat, Rabat
Childrens University Hospital, Belgrade
Clinic for Neurology and Psychiatry for Children and Youth, Belgrade
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic, Belgrade
Astra Kliinik, Tallinn
Irccs A.O.U.San Martino Ist, Genoa
University Clinical Centre of Nis, Niš
The Children's Hospital of Philadelphia, Philadelphia
Children's National Hospital, Washington D.C.
Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan
Johns Hopkins Medicine, Baltimore
University of Virginia Health System, Charlottesville
Hospital Universitario de la Princesa, Madrid
Hospital Universitario Ramon y Cajal, Madrid
Hospital Regional Universitario Carlos Haya, Málaga
Hassan II University Hospital, Fes
IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN, Trieste
CHRU de Montpellier, Hopital Gui de Chauliac, Montpellier
Universitätsmedizin Göttingen Georg-August-Universität, Göttingen
CHU Mohammed VI, Marrakesh
Hospital Universitario Virgen Macarena, Seville
The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company, Columbus
Hospital Civil Fray Antonio Alcalde, Guadalajara
Vestische Kinder- und Jugendklinik Datteln, Datteln
Universitätsklinikum Münster, Münster
Hospital de Cruces, Barakaldo
"KZ Dnipropetrovska oblasna dytiacha klinichna likarnia DOR", Dnipropetrovsk
Tartu University Hospital, Tartu
Centro de Investigacion Clinica Chapultepec S. A. de C. V., Morelia
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Kharkiv
Washington University, St Louis
Iecsi S.C., Monterrey
Universita? G. D'Annunzio, Chieti
Hopital de Hautepierre, Strasbourg
Hospices Civils de Lyon - Hôpital Pierre Wertheimer, Bron
Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari, Bari
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital, Lviv
Neurociencias Estudios Clinicos S.C., Culiacán
Children's Hospital Colorado, Aurora
Centro para el Desarrollo de la Medicina y de Asistencia, Culiacán
FAICIC S de R.L. de C.V, Veracruz
University of California San Francisco, San Francisco
Centre Hospitalier Universitaire de Bicêtre, Le Kremlin-Bicêtre
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania
All India Institute Of Medical Sciences (AIIMS), New Delhi
Fortis Flight Lieutenant Rajan Dhall Hospital, New Delhi
Artemis Hospital, Gurugram
Zydus Hospital, Ahmedabad
Seth G.S Medical College K.E.M Hospital, Mumbai
Deenanath Mangeshkar Hospital & Research Centre, Pune
Sparsh Super Speciality Hospital, Bangalore North
Amrita Institute of Medical Sciences and Research Centre, Kochi
UC San Diego, La Jolla
Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's Hospital, Boston
Robert Wood Johnson Medical School, New Brunswick
Cleveland Clinic, Mellen Center for Multiple Sclerosis, Cleveland
Baylor College of Medicine/Texas Children's Hospital, Houston
Clinica Universitaria Reina Fabiola, Córdoba
Centro de Investigaciones Médicas Tucuman, San Miguel de Tucumán
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME, Brasília
Instituto de Neurologia de Curitiba, Curitiba
Universidade de Caxias do Sul - Rio Grande do Sul, Caxias do Sul
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR, Porto Alegre
Hospital Sao Lucas - PUCRS, Porto Alegre
CPQuali Pesquisa Clínica Sao Paulo, São Paulo
Inst. Da Criança- Faculdade de Medicina Usp, São Paulo
University of Alberta Hospital, Edmonton
Children's Hospital of Eastern Ontario, Ottawa
The Hospital for Sick Children, Toronto
Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Dresden
Eginitio University General Hospital of Athens, Athens
University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA, Chaïdári
St. Luke's Hospital, Thessaloniki
Debreceni Egyetem Klinikai Kozpont, Debrecen
Ospedale Pediatrico Bambino Gesù, Rome
Azienda Ospedaliera Sant'Andrea, Rome
Children's Clinical University Hospital, Riga
Clinstile S.A de C.V., Mexico City
Instytut Centrum Zdrowia Matki Polki, ?ód?
Uniwersyteckie Centrum Kliniczne, Gda?sk
Uniwersytecki Szpital Kliniczny w Poznaniu, Późna
Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego, Warsaw
Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw
Hospital de Braga, Braga
ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra, Coimbra
Hospital Santo Antonio dos Capuchos, Lisbon
Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria, Lisbon
Victor Gomoiu Clinical Hospital for Children, Bucharest
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital, Bucharest
Hospital Sant Joan De Deu, Esplugues de Llobregas
Hospital Universitari Vall d'Hebron, Barcelona
Ukrainian medical rehabilitation center for children with organic lesions of the nervous system, Kyiv
Addenbrookes Hospital, Cambridge
Royal Hospital for Children and Young People, Edinburgh
Great Ormond Street Hospital For Children, London
Collaborators (1)
PPD Development, LP
INDUSTRY
Hoffmann-La Roche
INDUSTRY