A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis (Operetta 2)
Relapsing-Remitting Multiple Sclerosis
About this trial
This is an interventional treatment trial for Relapsing-Remitting Multiple Sclerosis focused on measuring pediatric Multiple Sclerosis, pediatric MS, children MS, children Multiple Sclerosis, pediatric 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
Sites / Locations
- UC San Diego; ACTRIRecruiting
- University of California San FranciscoRecruiting
- University of Colorado Denver Childrens Hospital Rocky Mountain MS CenterRecruiting
- Children's National HospitalRecruiting
- Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's HospitalRecruiting
- Washington University, Pediatric MS and other Demyelinating Disease CenterRecruiting
- NYU Langone Medical Center; Laura and Isaac Perlmutter Cancer Center
- Cleveland Clinic, Mellen Center for Multiple SclerosisRecruiting
- The Boster Center for MSRecruiting
- The Children's Hospital of PhiladelphiaRecruiting
- Baylor College of Medicine/Texas Children's HospitalRecruiting
- University of Virginia Health SystemRecruiting
- Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. GarrahanRecruiting
- Centro de Investigaciones Médicas Tucuman; REUMATHOLOGYRecruiting
- Royal Children's Hospital Melbourne - PINRecruiting
- Medizinische Universität Wien; Univ.Klinik fuer NeurologieRecruiting
- Hôpital Universitaire des Enfants Reine Fabiola; porte 10, batiment KRecruiting
- Cliniques Universitaires St-LucRecruiting
- UZ GentRecruiting
- L2 Ip - Instituto de Pesquisas Clinicas Ltda - MERecruiting
- Instituto de Neurologia de CuritibaRecruiting
- Universidade de Caxias do Sul - Rio Grande do SulRecruiting
- Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCRRecruiting
- Hospital Sao Lucas - PUCRSRecruiting
- CPQuali Pesquisa Clínica Sao PauloRecruiting
- Intituto PENSIRecruiting
- Inst. Da Criança- Faculdade de Medicina Usp; Unidade de PneumologiaRecruiting
- Multiprofile Hospital For Active Treatment In Neurology And Psychiatry (MHATNP) ''St. Naum"Recruiting
- University of Alberta HospitalRecruiting
- Children's Hospital of Eastern OntarioRecruiting
- Split University HospitalRecruiting
- Astra KliinikRecruiting
- Tartu University HospitalRecruiting
- Centre Hospitalier Universitaire de BicêtreRecruiting
- Hopital Pierre Wertheimer - Hopital Neurologique; Service de neurologieRecruiting
- CHRU de Montpellier, Hopital Gui de Chauliac; Service de NeuropediatrieRecruiting
- Vestische Kinder- und Jugendklinik DattelnRecruiting
- Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Kinder-und Jugendmedizin_UMGRecruiting
- Universitätsklinikum Münster; Klinik für Kinder- und JugendmedizinRecruiting
- Hospital Eginition; First Department of NeurologyRecruiting
- Attikon University General HospitalRecruiting
- Agios Loucas Clinic SARecruiting
- Hippokration General Hospital; First Department of PediatricsRecruiting
- Semmelweis EgyetemRecruiting
- Debreceni Egyetem Klinikai Központ; GyermekklinikaRecruiting
- Artemis HospitalRecruiting
- Sparsh Super Speciality HospitalRecruiting
- Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze ClinicheRecruiting
- A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed OdontostomatologicheRecruiting
- IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PINRecruiting
- A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)Recruiting
- Irccs A.O.U.San Martino Ist; DinogmiRecruiting
- IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi MultiplaRecruiting
- Azienda Ospedaliero Universitaria Policlinico Vittorio EmanueleRecruiting
- Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PINRecruiting
- Children's Clinical University HospitalRecruiting
- Hospital Civil Fray Antonio AlcaldeRecruiting
- Grupo Médico Camino S.C.Recruiting
- Clinstile S.A de C.V.Recruiting
- Centro de Investigacion Clinica Chapultepec S. A. de C. V.Recruiting
- Centro para el Desarrollo de la Medicina y de AsistenciaRecruiting
- Neurociencias Estudios Clinicos S.C.Recruiting
- Instituto de Investigaciones Aplicadas a la Neurociencia A.C.Recruiting
- Iecsi S.C.Recruiting
- FAICIC S de R.L. de C.V; FAICIC Clinical ResearchRecruiting
- Erasmus MCRecruiting
- Instytut Centrum Zdrowia Matki Polki; Klinika NeurologiiRecruiting
- Uniwersyteckie Centrum Kliniczne; Klinika Neurologii RozwojowejRecruiting
- Uniwersytecki Szpital Kliniczny w Poznaniu; Od. Kliniczny Neurologii Dzieci i M?odziezyRecruiting
- Instytut Pomnik Centrum Zdrowia Dziecka; Klinika Neurologii i EpileptologiiRecruiting
- Hospital de BragaRecruiting
- Centro Hospitalar e Universitário de Coimbra E.P.E.; Hospital PediátricoRecruiting
- Hospital Santo Antonio dos Capuchos; Servico de NeurologiaRecruiting
- Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria; Servicos FarmaceuticosRecruiting
- Spitalul Clinic de Psihiatrie ?Prof. dr. Alexandru Obregia?; Sectia Clinica Neurologie PediatricaRecruiting
- Childrens University HospitalRecruiting
- Clinic for Neurology and Psychiatry for Children and YouthRecruiting
- Mother and Child Health Care Institute of Serbia Dr Vukan CupicRecruiting
- University Clinical Center Kragujevac; Clinic of neurologyRecruiting
- University Clinical Centre of Nis; Clinic of neurologyRecruiting
- Clinical Centre of VojvodinaRecruiting
- Hospital Sant Joan De DeuRecruiting
- Hospital de Cruces; Servicio de NeurologiaRecruiting
- Hospital Universitari Vall d'HebronRecruiting
- Hospital Universitario de la Princesa; Servicio de NeurologiaRecruiting
- Hospital Universitario Ramon y CajalRecruiting
- Hospital Regional Universitario Carlos Haya; Servicio de NeurologiaRecruiting
- Hospital Universitario Virgen Macarena; Servicio de NeurologiaRecruiting
- State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
- Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
- KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR
- Birmingham Children's Hospital
- Great Ormond Street Hospital For Children; NeurologyRecruiting
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Ocrelizumab
Fingolimod
Participants will receive Ocrelizumab by IV infusion every 24 weeks. The first dose is given as dual infusions of half the dose of ocrelizumab on Days 1 and 15 and subsequent doses are given as single infusions of ocrelizumab every 24 weeks. Participants will also receive a placebo of fingolimod (administered as QD capsule).
Participants will receive Fingolimod PO QD as per the prescribing information provided with fingolimod. Patients will also receive a placebo of ocrelizumab (administered as IV infusions on Days 1 and 15, and every 24 weeks thereafter).