Multiple Sclerosis Clinical Trial

A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis

Summary

This double-blind, double-dummy study will evaluate the safety and efficacy of ocrelizumab compared with fingolimod in children and adolescents with relapsing-remitting multiple sclerosis aged between 10 and < 18 years over a duration of at least 96 weeks.

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Full Description

This Phase III randomized, double-blind, double-dummy, multicenter study will evaluate the safety and efficacy of ocrelizumab administered by IV infusion every 24 weeks compared with fingolimod taken orally daily, in children and adolescents with Multiple Sclerosis aged between 10 and < 18 years. The study plans to enroll 233 patients in a 1:1 randomization (ocrelizumab:fingolimod), globally. This study consists of a double-blind, double dummy period in which patients will be treated with either active ocrelizumab or active fingolimod for at least 96 weeks. Patients who complete the double-blind period will be offered the possibility to enter an optional open-label extension treatment period of at least 144 weeks with ocrelizumab.

View Eligibility Criteria

Eligibility Criteria

Inclusion Criteria:

Body weight ≥ 40 kg
Diagnosis of RRMS in accordance with the International Pediatric Multiple Sclerosis Study Group (IPMSSG) criteria for pediatric MS, Version 2012, or McDonald criteria 2017
EDSS at screening: 0-5.5, inclusive
Neurologic stability for ≥ 30 days prior to screening, and between screening and Day 1
At least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of at least one Gd enhancing lesion on MRI within 6 months

Exclusion Criteria:

Known presence or suspicion of other neurologic disorders that may mimic MS
Significant uncontrolled somatic diseases, known active infection or any other significant condition that may preclude patient from participating in the study
Patient with severe cardiac disease or significant findings on the screening ECG

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

171

Study ID:

NCT05123703

Recruitment Status:

Recruiting

Sponsor:

Hoffmann-La Roche

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There are 113 Locations for this study

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UC San Diego; ACTRI
La Jolla California, 92037, United States
University of California San Francisco
San Francisco California, 94117, United States
University of Colorado Denver Childrens Hospital Rocky Mountain MS Center
Aurora Colorado, 80045, United States
Children's National Hospital
Washington District of Columbia, 20010, United States
University of Chicago Medical Center
Chicago Illinois, 60637, United States
Johns Hopkins Medicine
Baltimore Maryland, 21287, United States
Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's Hospital
Boston Massachusetts, 02115, United States
Washington University, Pediatric MS and other Demyelinating Disease Center
Saint Louis Missouri, 63110, United States
Robert Wood Johnson Medical School
New Brunswick New Jersey, 08901, United States
NYU Langone Medical Center; Laura and Isaac Perlmutter Cancer Center
New York New York, 10016, United States
Cleveland Clinic, Mellen Center for Multiple Sclerosis
Cleveland Ohio, 44195, United States
The Boster Center for MS
Columbus Ohio, 43235, United States
The Children's Hospital of Philadelphia
Philadelphia Pennsylvania, 19104, United States
Baylor College of Medicine/Texas Children's Hospital
Houston Texas, 77030, United States
University of Virginia Health System
Charlottesville Virginia, 22908, United States
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
Ciudad Autonoma Buenos Aires , C1249, Argentina
Clinica Universitaria Reina Fabiola
Cordoba , X5004, Argentina
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
San Miguel , T4000, Argentina
Royal Children's Hospital Melbourne - PIN
Parkville Victoria, 3052, Australia
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
Wien , 1090, Austria
Hôpital Universitaire des Enfants Reine Fabiola; porte 10, batiment K
Brussel , 1020, Belgium
Cliniques Universitaires St-Luc
Bruxelles , 1200, Belgium
UZ Gent
Gent , 9000, Belgium
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
Brasilia DF, 70200, Brazil
Instituto de Neurologia de Curitiba
Curitiba PR, 81210, Brazil
Universidade de Caxias do Sul - Rio Grande do Sul
Caxias do Sul RS, 95070, Brazil
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
Porto Alegre RS, 90430, Brazil
Hospital Sao Lucas - PUCRS
Porto Alegre RS, 90610, Brazil
CPQuali Pesquisa Clínica Sao Paulo
Sao Paulo SP, 01228, Brazil
Intituto PENSI
Sao Paulo SP, 01228, Brazil
Inst. Da Criança- Faculdade de Medicina Usp; Unidade de Pneumologia
Sao Paulo SP, 05403, Brazil
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry (MHATNP) ''St. Naum"
Sofia , 1797, Bulgaria
University of Alberta Hospital
Edmonton Alberta, T6G 1, Canada
Children's Hospital of Eastern Ontario
Ottawa Ontario, K1H 8, Canada
The Hospital for Sick Children
Toronto Ontario, M5G 1, Canada
University Hospital of Split
Split , 21000, Croatia
Children's Hospital Srebrnjak
Zagreb , 10000, Croatia
Aarhus Universitetshospital
Aarhus N , 8200 , Denmark
Rigshospitalet Glostrup; Neurologisk Klinik
Glostrup , 2600, Denmark
Astra Kliinik
Tallinn , 11315, Estonia
Tartu University Hospital
Tartu , 51014, Estonia
Centre Hospitalier Universitaire de Bicêtre
Le Kremlin-bicêtre , 94275, France
Hopital Pierre Wertheimer - Hopital Neurologique; Service de neurologie
Lyon , 69394, France
CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie
Montpellier , 34295, France
Hopital de Hautepierre
Strasbourg , 67091, France
Vestische Kinder- und Jugendklinik Datteln
Datteln , 45711, Germany
Universitaetsklinikum Carl Gustav Carus an der TU Dresden
Dresden , 01307, Germany
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Kinder-und Jugendmedizin_UMG
Göttingen , 37075, Germany
Universitätsklinikum Münster; Klinik für Kinder- und Jugendmedizin
Muenster , 48129, Germany
Hospital Eginition; First Department of Neurology
Athens , 115 2, Greece
Attikon University General Hospital
Chaidari , 124 6, Greece
Agios Loucas Clinic SA
Panorama , 552 3, Greece
Hippokration General Hospital; First Department of Pediatrics
Thessaloniki , 546 4, Greece
Semmelweis Egyetem; Belgyogyaszati es Hematologiai Klinika
Budapest , 1088, Hungary
Debreceni Egyetem Klinikai Központ; Gyermekklinika
Debrecen , 4032, Hungary
All India Institute Of Medical Sciences (AIIMS)
New Delhi Delhi, 11002, India
Fortis Flight Lieutenant Rajan Dhall Hospital
New Delhi Delhi, 11007, India
Zydus Hospital; Department of Neuro Sciences
Ahmadabad CITY Gujarat, 38005, India
Artemis Hospital
Gurugram Haryana, 12200, India
Sparsh Super Speciality Hospital
Bangalore North Karnataka, 56002, India
Amrita Institute of Medical Sciences and Research Centre
Kochi Kerala, 68200, India
Seth G.S Medical College K.E.M Hospital
Mumbai Maharashtra, 40001, India
Deenanath Mangeshkar Hospital & Research Centre
Pune Maharashtra, 41100, India
Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche
Chieti Abruzzo, 66100, Italy
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
Napoli Campania, 80131, Italy
IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN
Trieste Friuli-Venezia Giulia, 34137, Italy
Ospedale Pediatrico Bambino Gesù; Divisione di Neurologia
Roma Lazio, 00165, Italy
A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)
Roma Lazio, 00189, Italy
Irccs A.O.U.San Martino Ist; Dinogmi
Genova Liguria, 16132, Italy
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
Milano Lombardia, 20132, Italy
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
Catania Sicilia, 95123, Italy
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
Pisa Toscana, 58126, Italy
Children's Clinical University Hospital
Riga , LV-10, Latvia
Hospital Civil Fray Antonio Alcalde
Guadalajara Jalisco, 44280, Mexico
Grupo Médico Camino S.C.
Ciudad de México Mexico CITY (federal District), 03600, Mexico
Clinstile S.A de C.V.
Mexico City Mexico CITY (federal District), 06700, Mexico
Centro de Investigacion Clinica Chapultepec S. A. de C. V.
Morelia Michoacan, 58260, Mexico
Centro para el Desarrollo de la Medicina y de Asistencia
Culiacán Rosales Sinaloa, 80230, Mexico
Neurociencias Estudios Clinicos S.C.
Culiacán Sinaloa, 80020, Mexico
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
Durango , 34000, Mexico
Iecsi S.C.
Monterrey , 64310, Mexico
FAICIC S de R.L. de C.V; FAICIC Clinical Research
Veracruz , 91900, Mexico
Hassan II University Hospital
Fez , 30050, Morocco
CHU Mohammed VI
Marrakech , 40080, Morocco
Centre Hospitalier Ibn Sina CHIS - Hopital des Specialites
Rabat , 10100, Morocco
Hospital Militaire Dinstruction Mohammed V de Rabat
Rabat , 10100, Morocco
Erasmus MC
Rotterdam , 3015 , Netherlands
Instytut Centrum Zdrowia Matki Polki; Klinika Neurologii Rozwojowej i Epileptologii
?ód? , 93-33, Poland
Uniwersyteckie Centrum Kliniczne; Klinika Neurologii Rozwojowej
Gda?sk , 80-95, Poland
Uniwersytecki Szpital Kliniczny w Poznaniu; Od. Kliniczny Neurologii Dzieci i M?odziezy
Pozna? , 60-35, Poland
Dzieci?cy Szpital Kliniczny im. Józefa Polikarpa Brudzi?skiego; Klinika Neurologii Dzieciecej
Warszawa , 02-09, Poland
Instytut Pomnik Centrum Zdrowia Dziecka; Klinika Neurologii i Epileptologii
Warszawa , 04-73, Poland
Hospital de Braga
Braga , 4710-, Portugal
Centro Hospitalar e Universitário de Coimbra E.P.E.; Hospital Pediátrico
Coimbra , 3000-, Portugal
Hospital Santo Antonio dos Capuchos; Servico de Neurologia
Lisboa , 1169-, Portugal
Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria; Servicos Farmaceuticos
Lisboa , 1649-, Portugal
Victor Gomoiu Clinical Hospital for Children
Bucuresti , 02210, Romania
Prof Dr Alexandru Obregia Clinical Psychiatric Hospital
Bucuresti , 04191, Romania
Childrens University Hospital
Belgrade , 11000, Serbia
Clinic for Neurology and Psychiatry for Children and Youth
Belgrade , 11000, Serbia
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
Belgrade , 11000, Serbia
University Clinical Center Kragujevac; Clinic of neurology
Kragujevac , 34000, Serbia
University Clinical Centre of Nis; Clinic of neurology
NIS , 18000, Serbia
Clinical Centre of Vojvodina
Nova Sad , 21000, Serbia
Hospital Sant Joan De Deu
Esplugues De Llobregas Barcelona, 08950, Spain
Hospital de Cruces; Servicio de Neurologia
Barakaldo Vizcaya, 48903, Spain
Hospital Universitari Vall d'Hebron
Barcelona , 08035, Spain
Hospital Universitario de la Princesa; Servicio de Neurologia
Madrid , 28006, Spain
Hospital Universitario Ramon y Cajal
Madrid , 28034, Spain
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
Malaga , 29010, Spain
Hospital Universitario Virgen Macarena; Servicio de Neurologia
Sevilla , 41009, Spain
Hôpitaux Universit. de Genève Méd.Neurologie; Unité de Neurologie pédiatrique
Genève , 1205, Switzerland
Kinderspital Zurich - Eleonorenstiftung
Zürich , 8032, Switzerland
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
Lviv Kharkiv Governorate, 79010, Ukraine
KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR
Dnipropetrovsk Tavria Okruha, 49100, Ukraine
Birmingham Children's Hospital
Birmingham , B4 6N, United Kingdom
Addenbrookes Hospital
Cambridge , CB2 0, United Kingdom
Royal Hospital for Children and Young People
Edinburgh , EH51, United Kingdom
Great Ormond Street Hospital For Children; Neurology
London , WC1N , United Kingdom

How clear is this clinincal trial information?

Study is for people with:

Multiple Sclerosis

Phase:

Phase 3

Estimated Enrollment:

171

Study ID:

NCT05123703

Recruitment Status:

Recruiting

Sponsor:


Hoffmann-La Roche

How clear is this clinincal trial information?

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