A Study to Evaluate Safety and Efficacy of Ocrelizumab in Comparison With Fingolimod in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis (RRMS)

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

188

Participants

Timeline

Start Date

May 19, 2022

Primary Completion Date

June 9, 2025

Study Completion Date

September 17, 2029

Conditions
Relapsing-Remitting Multiple Sclerosis
Interventions
DRUG

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.

OTHER

Ocrelizumab Placebo

Ocrelizumab matching placebo will be administered by IV infusion on Day 1 and Day 15 and Q24W thereafter.

DRUG

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).

OTHER

Fingolimod Placebo

Fingolimod matching placebo will be administered daily as a capsule.

Trial Locations (105)

1020

Hôpital Universitaire des Enfants Reine Fabiola, Brussels

1090

Medizinische Universität Wien, Vienna

1094

Semmelweis Egyetem, Budapest

1133

Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan, Ciudad de Buenos Aires

1200

Cliniques Universitaires St-Luc, Brussels

3052

Royal Children's Hospital Melbourne - PIN, Parkville

3310

Grupo Médico Camino S.C., Mexico City

8008

Universitäts-Kinderspital Zürich - Eleonorenstiftung, Zurich

9000

UZ Gent, Ghent

10100

Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites, Rabat

Hospital Militaire Dinstruction Mohammed V de Rabat, Rabat

11000

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

11315

Astra Kliinik, Tallinn

16132

Irccs A.O.U.San Martino Ist, Genoa

18000

University Clinical Centre of Nis, Niš

19104

The Children's Hospital of Philadelphia, Philadelphia

20010

Children's National Hospital, Washington D.C.

20133

Fondazione IRCCS Istituto Neurologico Carlo Besta, Milan

21287

Johns Hopkins Medicine, Baltimore

22903

University of Virginia Health System, Charlottesville

28006

Hospital Universitario de la Princesa, Madrid

28034

Hospital Universitario Ramon y Cajal, Madrid

29010

Hospital Regional Universitario Carlos Haya, Málaga

30000

Hassan II University Hospital, Fes

34137

IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN, Trieste

34295

CHRU de Montpellier, Hopital Gui de Chauliac, Montpellier

37075

Universitätsmedizin Göttingen Georg-August-Universität, Göttingen

40000

CHU Mohammed VI, Marrakesh

41009

Hospital Universitario Virgen Macarena, Seville

43235

The Boster Center for Multiple Sclerosis a Singlepoint Healthcare Company, Columbus

44280

Hospital Civil Fray Antonio Alcalde, Guadalajara

45711

Vestische Kinder- und Jugendklinik Datteln, Datteln

48129

Universitätsklinikum Münster, Münster

48903

Hospital de Cruces, Barakaldo

49100

"KZ Dnipropetrovska oblasna dytiacha klinichna likarnia DOR", Dnipropetrovsk

50406

Tartu University Hospital, Tartu

58260

Centro de Investigacion Clinica Chapultepec S. A. de C. V., Morelia

61068

State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine, Kharkiv

63101

Washington University, St Louis

64310

Iecsi S.C., Monterrey

66100

Universita? G. D'Annunzio, Chieti

67091

Hopital de Hautepierre, Strasbourg

69003

Hospices Civils de Lyon - Hôpital Pierre Wertheimer, Bron

70124

Azienda Ospedaliero-Universitaria Consorziale Pol. di Bari, Bari

79010

Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital, Lviv

80020

Neurociencias Estudios Clinicos S.C., Culiacán

80045

Children's Hospital Colorado, Aurora

80230

Centro para el Desarrollo de la Medicina y de Asistencia, Culiacán

91900

FAICIC S de R.L. de C.V, Veracruz

94117

University of California San Francisco, San Francisco

94275

Centre Hospitalier Universitaire de Bicêtre, Le Kremlin-Bicêtre

95123

Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele, Catania

110029

All India Institute Of Medical Sciences (AIIMS), New Delhi

110070

Fortis Flight Lieutenant Rajan Dhall Hospital, New Delhi

122001

Artemis Hospital, Gurugram

380054

Zydus Hospital, Ahmedabad

400012

Seth G.S Medical College K.E.M Hospital, Mumbai

411004

Deenanath Mangeshkar Hospital & Research Centre, Pune

560022

Sparsh Super Speciality Hospital, Bangalore North

682001

Amrita Institute of Medical Sciences and Research Centre, Kochi

92037-1337

UC San Diego, La Jolla

02115

Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's Hospital, Boston

08901

Robert Wood Johnson Medical School, New Brunswick

44195-0001

Cleveland Clinic, Mellen Center for Multiple Sclerosis, Cleveland

77030-2608

Baylor College of Medicine/Texas Children's Hospital, Houston

X5000FHP

Clinica Universitaria Reina Fabiola, Córdoba

T4000AXL

Centro de Investigaciones Médicas Tucuman, San Miguel de Tucumán

70200-730

L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME, Brasília

81210-310

Instituto de Neurologia de Curitiba, Curitiba

95070-560

Universidade de Caxias do Sul - Rio Grande do Sul, Caxias do Sul

90430-001

Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR, Porto Alegre

90610-000

Hospital Sao Lucas - PUCRS, Porto Alegre

01228-000

CPQuali Pesquisa Clínica Sao Paulo, São Paulo

05403-900

Inst. Da Criança- Faculdade de Medicina Usp, São Paulo

T6G 1Z1

University of Alberta Hospital, Edmonton

K1H 8L1

Children's Hospital of Eastern Ontario, Ottawa

M5G 1X8

The Hospital for Sick Children, Toronto

01307

Universitaetsklinikum Carl Gustav Carus an der TU Dresden, Dresden

115 28

Eginitio University General Hospital of Athens, Athens

124 62

University General Hospital ''ATTIKON'' - General Hospital of West Attica H AGIA VARVARA, Chaïdári

552 36

St. Luke's Hospital, Thessaloniki

H-4032

Debreceni Egyetem Klinikai Kozpont, Debrecen

00165

Ospedale Pediatrico Bambino Gesù, Rome

00189

Azienda Ospedaliera Sant'Andrea, Rome

LV-1004

Children's Clinical University Hospital, Riga

06700

Clinstile S.A de C.V., Mexico City

93-338

Instytut Centrum Zdrowia Matki Polki, ?ód?

80-952

Uniwersyteckie Centrum Kliniczne, Gda?sk

60-355

Uniwersytecki Szpital Kliniczny w Poznaniu, Późna

02-091

Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego, Warsaw

04-730

Instytut Pomnik Centrum Zdrowia Dziecka, Warsaw

4710-243

Hospital de Braga, Braga

3000-602

ULS de Coimbra, EPE - Hospitais da Universidade de Coimbra, Coimbra

1169-050

Hospital Santo Antonio dos Capuchos, Lisbon

1649-035

Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria, Lisbon

022102

Victor Gomoiu Clinical Hospital for Children, Bucharest

041914

Prof Dr Alexandru Obregia Clinical Psychiatric Hospital, Bucharest

08950

Hospital Sant Joan De Deu, Esplugues de Llobregas

08035

Hospital Universitari Vall d'Hebron, Barcelona

04209

Ukrainian medical rehabilitation center for children with organic lesions of the nervous system, Kyiv

CB2 0QQ

Addenbrookes Hospital, Cambridge

EH51

Royal Hospital for Children and Young People, Edinburgh

WC1N 3JH

Great Ormond Street Hospital For Children, London

Sponsors

Collaborators (1)

All Listed Sponsors
collaborator

PPD Development, LP

INDUSTRY

lead

Hoffmann-La Roche

INDUSTRY