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.
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.
Eligibility Criteria
Inclusion Criteria:
Body weight ≥ 50 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
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There are 73 Locations for this study
La Jolla California, 92037, United States
Aurora Colorado, 80045, United States
Boston Massachusetts, 02115, United States
Saint Louis Missouri, 63110, United States
New York New York, 10016, United States
Cleveland Ohio, 44195, United States
Columbus Ohio, 43235, United States
Philadelphia Pennsylvania, 19104, United States
Houston Texas, 77030, United States
Charlottesville Virginia, 22903, United States
Ciudad Autonoma Buenos Aires , C1249, Argentina
San Miguel , T4000, Argentina
Parkville Victoria, 3052, Australia
Wien , 1090, Austria
Brussel , 1020, Belgium
Bruxelles , 1200, Belgium
Gent , 9000, Belgium
Brasilia DF, 70200, Brazil
Curitiba PR, 81210, Brazil
Caxias do Sul RS, 95070, Brazil
Porto Alegre RS, 90430, Brazil
Porto Alegre RS, 90610, Brazil
Sao Paulo SP, 01228, Brazil
Sofia , 1797, Bulgaria
Edmonton Alberta, T6G 1, Canada
Ottawa Ontario, K1H 8, Canada
Le Kremlin-bicêtre , 94275, France
Lyon , 69394, France
Montpellier , 34295, France
Datteln , 45711, Germany
Göttingen , 37075, Germany
Muenster , 48129, Germany
Athens , 115 2, Greece
Chaidari , 124 6, Greece
Panorama , 552 3, Greece
Thessaloniki , 546 4, Greece
Debrecen , 4032, Hungary
Chieti Abruzzo, 66100, Italy
Napoli Campania, 80131, Italy
Trieste Friuli-Venezia Giulia, 34137, Italy
Roma Lazio, 00189, Italy
Genova Liguria, 16132, Italy
Milano Lombardia, 20132, Italy
Catania Sicilia, 95123, Italy
Riga , LV-10, Latvia
Guadalajara Jalisco, 44280, Mexico
Ciudad de México Mexico CITY (federal District), 03600, Mexico
Mexico City Mexico CITY (federal District), 06700, Mexico
Culiacán Rosales Sinaloa, 80230, Mexico
Culiacán Sinaloa, 80020, Mexico
Durango , 34000, Mexico
Veracruz , 91900, Mexico
?ód? , 93-33, Poland
Gda?sk , 80-95, Poland
Pozna? , 60-35, Poland
Warszawa , 04-73, Poland
Braga , 4710-, Portugal
Coimbra , 3000-, Portugal
Lisboa , 1169-, Portugal
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Belgrade , 11000, Serbia
Kragujevac , 34000, Serbia
Nis , 18000, Serbia
Esplugues De Llobregas Barcelona, 08950, Spain
Barakaldo Vizcaya, 48903, Spain
Barcelona , 08035, Spain
Madrid , 28006, Spain
Madrid , 28034, Spain
Malaga , 29010, Spain
Sevilla , 41009, Spain
Kharkiv Kharkiv Governorate, 61068, Ukraine
Lviv Kharkiv Governorate, 79010, Ukraine
Dnipropetrovsk Tavria Okruha, 49100, Ukraine
Birmingham , B4 6N, United Kingdom
London , WC1N , United Kingdom
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