Back to resultsA Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis (Operetta 2)
Primary Purpose
Relapsing-Remitting Multiple Sclerosis
Status
Recruiting
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ocrelizumab
Ocrelizumab Placebo
Fingolimod
Fingolimod Placebo
Sponsored by
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
Arm Type
Experimental
Active Comparator
Arm Label
Ocrelizumab
Fingolimod
Arm Description
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).
Outcomes
Primary Outcome Measures
Annualized relapse rate (ARR)
Secondary Outcome Measures
Number of new or enlarging T2-hyperintense lesions (T2 lesions) as detected by brain MRI during the double-blind period
Number of new or enlarging T2 lesions by Week 96
Annualized relapse rate (ARR) by Week 96
Number of T1 Gd lesions at Week 12
Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Prevalence of ADAs at baseline and incidence of ADAs during the study
Full Information
NCT ID
NCT05123703
First Posted
November 16, 2021
Last Updated
October 3, 2023
Sponsor
Hoffmann-La Roche
Collaborators
PPD
1. Study Identification
Unique Protocol Identification Number
NCT05123703
Brief Title
A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis
Acronym
Operetta 2
Official Title
A Phase III Multicenter, Randomized, Double-Blind, Double-Dummy Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
February 4, 2022 (Actual)
Primary Completion Date
July 7, 2025 (Anticipated)
Study Completion Date
November 5, 2025 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hoffmann-La Roche
Collaborators
PPD
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
Detailed 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Relapsing-Remitting Multiple Sclerosis
Keywords
pediatric Multiple Sclerosis, pediatric MS, children MS, children Multiple Sclerosis, pediatric ocrelizumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
233 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Ocrelizumab
Arm Type
Experimental
Arm Description
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).
Arm Title
Fingolimod
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Drug
Intervention Name(s)
Ocrelizumab
Intervention Description
Ocrelizumab will be administered at a dose of 600 mg by IV infusion on Day 1 and Day 15 (half the dose, 2 weeks apart) and every 24 weeks thereafter.
Intervention Type
Other
Intervention Name(s)
Ocrelizumab Placebo
Intervention Description
Ocrelizumab placebo will be administered by IV infusion on day 1 and Day 15 and every 24 weeks thereafter.
Intervention Type
Drug
Intervention Name(s)
Fingolimod
Intervention Description
Fingolimod will be administered daily as 0.5 mg capsule.
Intervention Type
Other
Intervention Name(s)
Fingolimod Placebo
Intervention Description
Fingolimod placebo will be administsred daily as a capsule.
Primary Outcome Measure Information:
Title
Annualized relapse rate (ARR)
Time Frame
Baseline up to approximately 4 years
Secondary Outcome Measure Information:
Title
Number of new or enlarging T2-hyperintense lesions (T2 lesions) as detected by brain MRI during the double-blind period
Time Frame
Baseline up to approximately 4 years
Title
Number of new or enlarging T2 lesions by Week 96
Time Frame
Baseline up to Week 96
Title
Annualized relapse rate (ARR) by Week 96
Time Frame
Baseline up to Week 96
Title
Number of T1 Gd lesions at Week 12
Time Frame
Week 12
Title
Incidence and severity of adverse events, with severity determined according to National Cancer Institute Common Terminology Criteria for Adverse Events, Version 5.0 (NCI CTCAE v5.0)
Time Frame
Baseline up to approximately 8 years
Title
Prevalence of ADAs at baseline and incidence of ADAs during the study
Time Frame
Baseline up to approximately 8 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Reference Study ID Number: WN42086 https://forpatients.roche.com/
Phone
888-662-6728 (U.S. and Canada)
Email
global-roche-genentech-trials@gene.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trials
Organizational Affiliation
Hoffmann-La Roche
Official's Role
Study Director
Facility Information:
Facility Name
UC San Diego; ACTRI
City
La Jolla
State/Province
California
ZIP/Postal Code
92037
Country
United States
Individual Site Status
Recruiting
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94117
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Colorado Denver Childrens Hospital Rocky Mountain MS Center
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's National Hospital
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20010
Country
United States
Individual Site Status
Recruiting
Facility Name
Pediatric Multiple Sclerosis and Related Disorders Program at Boston Children's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Recruiting
Facility Name
Washington University, Pediatric MS and other Demyelinating Disease Center
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Individual Site Status
Recruiting
Facility Name
NYU Langone Medical Center; Laura and Isaac Perlmutter Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
Individual Site Status
Withdrawn
Facility Name
Cleveland Clinic, Mellen Center for Multiple Sclerosis
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Name
The Boster Center for MS
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43235
Country
United States
Individual Site Status
Recruiting
Facility Name
The Children's Hospital of Philadelphia
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Individual Site Status
Recruiting
Facility Name
Baylor College of Medicine/Texas Children's Hospital
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia Health System
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Recruiting
Facility Name
Hospital de Pediatría S.A.M.I.C.- Prof. Dr. Juan P. Garrahan
City
Ciudad Autonoma Buenos Aires
ZIP/Postal Code
C1249ABN
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Centro de Investigaciones Médicas Tucuman; REUMATHOLOGY
City
San Miguel
ZIP/Postal Code
T4000AXL
Country
Argentina
Individual Site Status
Recruiting
Facility Name
Royal Children's Hospital Melbourne - PIN
City
Parkville
State/Province
Victoria
ZIP/Postal Code
3052
Country
Australia
Individual Site Status
Recruiting
Facility Name
Medizinische Universität Wien; Univ.Klinik fuer Neurologie
City
Wien
ZIP/Postal Code
1090
Country
Austria
Individual Site Status
Recruiting
Facility Name
Hôpital Universitaire des Enfants Reine Fabiola; porte 10, batiment K
City
Brussel
ZIP/Postal Code
1020
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires St-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Gent
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
L2 Ip - Instituto de Pesquisas Clinicas Ltda - ME
City
Brasilia
State/Province
DF
ZIP/Postal Code
70200-730
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Instituto de Neurologia de Curitiba
City
Curitiba
State/Province
PR
ZIP/Postal Code
81210-310
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Universidade de Caxias do Sul - Rio Grande do Sul
City
Caxias do Sul
State/Province
RS
ZIP/Postal Code
95070-560
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Nucleo de Pesquisa Clinica do Rio Grande do Sul NPCR
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90430-001
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Hospital Sao Lucas - PUCRS
City
Porto Alegre
State/Province
RS
ZIP/Postal Code
90610-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
CPQuali Pesquisa Clínica Sao Paulo
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01228-000
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Intituto PENSI
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
01228-200
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Inst. Da Criança- Faculdade de Medicina Usp; Unidade de Pneumologia
City
Sao Paulo
State/Province
SP
ZIP/Postal Code
05403-900
Country
Brazil
Individual Site Status
Recruiting
Facility Name
Multiprofile Hospital For Active Treatment In Neurology And Psychiatry (MHATNP) ''St. Naum"
City
Sofia
ZIP/Postal Code
1797
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
University of Alberta Hospital
City
Edmonton
State/Province
Alberta
ZIP/Postal Code
T6G 1Z1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Eastern Ontario
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H 8L1
Country
Canada
Individual Site Status
Recruiting
Facility Name
Split University Hospital
City
Split
ZIP/Postal Code
21000
Country
Croatia
Individual Site Status
Recruiting
Facility Name
Astra Kliinik
City
Tallinn
ZIP/Postal Code
11315
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Tartu University Hospital
City
Tartu
ZIP/Postal Code
51014
Country
Estonia
Individual Site Status
Recruiting
Facility Name
Centre Hospitalier Universitaire de Bicêtre
City
Le Kremlin-bicêtre
ZIP/Postal Code
94275
Country
France
Individual Site Status
Recruiting
Facility Name
Hopital Pierre Wertheimer - Hopital Neurologique; Service de neurologie
City
Lyon
ZIP/Postal Code
69394
Country
France
Individual Site Status
Recruiting
Facility Name
CHRU de Montpellier, Hopital Gui de Chauliac; Service de Neuropediatrie
City
Montpellier
ZIP/Postal Code
34295
Country
France
Individual Site Status
Recruiting
Facility Name
Vestische Kinder- und Jugendklinik Datteln
City
Datteln
ZIP/Postal Code
45711
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsmedizin Göttingen Georg-August-Universität; Klinik für Kinder-und Jugendmedizin_UMG
City
Göttingen
ZIP/Postal Code
37075
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitätsklinikum Münster; Klinik für Kinder- und Jugendmedizin
City
Muenster
ZIP/Postal Code
48129
Country
Germany
Individual Site Status
Recruiting
Facility Name
Hospital Eginition; First Department of Neurology
City
Athens
ZIP/Postal Code
115 28
Country
Greece
Individual Site Status
Recruiting
Facility Name
Attikon University General Hospital
City
Chaidari
ZIP/Postal Code
124 62
Country
Greece
Individual Site Status
Recruiting
Facility Name
Agios Loucas Clinic SA
City
Panorama
ZIP/Postal Code
552 36
Country
Greece
Individual Site Status
Recruiting
Facility Name
Hippokration General Hospital; First Department of Pediatrics
City
Thessaloniki
ZIP/Postal Code
546 42
Country
Greece
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem
City
Budapest
ZIP/Postal Code
1088
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Debreceni Egyetem Klinikai Központ; Gyermekklinika
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Artemis Hospital
City
Gurugram
State/Province
Haryana
ZIP/Postal Code
122001
Country
India
Individual Site Status
Recruiting
Facility Name
Sparsh Super Speciality Hospital
City
Bangalore North
State/Province
Karnataka
ZIP/Postal Code
560022
Country
India
Individual Site Status
Recruiting
Facility Name
Universita? G. D'Annunzio; Dipartimento di Neuroscienze, Imaging e Scienze Cliniche
City
Chieti
State/Province
Abruzzo
ZIP/Postal Code
66100
Country
Italy
Individual Site Status
Recruiting
Facility Name
A. O. U. Federico II; Dip Neuroscienze, Scienze Riproduttive ed Odontostomatologiche
City
Napoli
State/Province
Campania
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Materno Infantile Burlo Garofolo - INCIPIT - PIN
City
Trieste
State/Province
Friuli-Venezia Giulia
ZIP/Postal Code
34137
Country
Italy
Individual Site Status
Recruiting
Facility Name
A.O. Sant'Andrea; UOC Neurologia, Dip. di Neuroscienze, Salute Mentale e Organi di Senso (NESMOS)
City
Roma
State/Province
Lazio
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Name
Irccs A.O.U.San Martino Ist; Dinogmi
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale San Raffaele; Neurologia Neurofisiologia Neuroriabilitazione-Centro Sclerosi Multipla
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20132
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria Policlinico Vittorio Emanuele
City
Catania
State/Province
Sicilia
ZIP/Postal Code
95123
Country
Italy
Individual Site Status
Recruiting
Facility Name
Azienda Ospedaliero Universitaria A Meyer - INCIPIT - PIN
City
Pisa
State/Province
Toscana
ZIP/Postal Code
58126
Country
Italy
Individual Site Status
Recruiting
Facility Name
Children's Clinical University Hospital
City
Riga
ZIP/Postal Code
LV-1004
Country
Latvia
Individual Site Status
Recruiting
Facility Name
Hospital Civil Fray Antonio Alcalde
City
Guadalajara
State/Province
Jalisco
ZIP/Postal Code
44280
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Grupo Médico Camino S.C.
City
Ciudad de México
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
03600
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Clinstile S.A de C.V.
City
Mexico City
State/Province
Mexico CITY (federal District)
ZIP/Postal Code
06700
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro de Investigacion Clinica Chapultepec S. A. de C. V.
City
Morelia
State/Province
Michoacan
ZIP/Postal Code
58260
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Centro para el Desarrollo de la Medicina y de Asistencia
City
Culiacán Rosales
State/Province
Sinaloa
ZIP/Postal Code
80230
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Neurociencias Estudios Clinicos S.C.
City
Culiacán
State/Province
Sinaloa
ZIP/Postal Code
80020
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Instituto de Investigaciones Aplicadas a la Neurociencia A.C.
City
Durango
ZIP/Postal Code
34000
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Iecsi S.C.
City
Monterrey
ZIP/Postal Code
64310
Country
Mexico
Individual Site Status
Recruiting
Facility Name
FAICIC S de R.L. de C.V; FAICIC Clinical Research
City
Veracruz
ZIP/Postal Code
91900
Country
Mexico
Individual Site Status
Recruiting
Facility Name
Erasmus MC
City
Rotterdam
ZIP/Postal Code
3015 GD
Country
Netherlands
Individual Site Status
Recruiting
Facility Name
Instytut Centrum Zdrowia Matki Polki; Klinika Neurologii
City
?ód?
ZIP/Postal Code
93-338
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersyteckie Centrum Kliniczne; Klinika Neurologii Rozwojowej
City
Gda?sk
ZIP/Postal Code
80-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Uniwersytecki Szpital Kliniczny w Poznaniu; Od. Kliniczny Neurologii Dzieci i M?odziezy
City
Pozna?
ZIP/Postal Code
60-355
Country
Poland
Individual Site Status
Recruiting
Facility Name
Instytut Pomnik Centrum Zdrowia Dziecka; Klinika Neurologii i Epileptologii
City
Warszawa
ZIP/Postal Code
04-730
Country
Poland
Individual Site Status
Recruiting
Facility Name
Hospital de Braga
City
Braga
ZIP/Postal Code
4710-243
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar e Universitário de Coimbra E.P.E.; Hospital Pediátrico
City
Coimbra
ZIP/Postal Code
3000-602
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Hospital Santo Antonio dos Capuchos; Servico de Neurologia
City
Lisboa
ZIP/Postal Code
1169-050
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Centro Hospitalar Lisboa Norte, E.P.E. ? Hospital de Santa Maria; Servicos Farmaceuticos
City
Lisboa
ZIP/Postal Code
1649-035
Country
Portugal
Individual Site Status
Recruiting
Facility Name
Spitalul Clinic de Psihiatrie ?Prof. dr. Alexandru Obregia?; Sectia Clinica Neurologie Pediatrica
City
Bucuresti
ZIP/Postal Code
041914
Country
Romania
Individual Site Status
Recruiting
Facility Name
Childrens University Hospital
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinic for Neurology and Psychiatry for Children and Youth
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Mother and Child Health Care Institute of Serbia Dr Vukan Cupic
City
Belgrade
ZIP/Postal Code
11000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
University Clinical Center Kragujevac; Clinic of neurology
City
Kragujevac
ZIP/Postal Code
34000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
University Clinical Centre of Nis; Clinic of neurology
City
NIS
ZIP/Postal Code
18000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Clinical Centre of Vojvodina
City
Nova Sad
ZIP/Postal Code
21000
Country
Serbia
Individual Site Status
Recruiting
Facility Name
Hospital Sant Joan De Deu
City
Esplugues De Llobregas
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital de Cruces; Servicio de Neurologia
City
Barakaldo
State/Province
Vizcaya
ZIP/Postal Code
48903
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitari Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario de la Princesa; Servicio de Neurologia
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Ramon y Cajal
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Regional Universitario Carlos Haya; Servicio de Neurologia
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario Virgen Macarena; Servicio de Neurologia
City
Sevilla
ZIP/Postal Code
41009
Country
Spain
Individual Site Status
Recruiting
Facility Name
State Institution Institute of Neurology, Psychiatry and Narcology of NAMS of Ukraine
City
Kharkiv
State/Province
Kharkiv Governorate
ZIP/Postal Code
61068
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Communal noncommercial enterprise of Lviv Regional Council Lviv Regional Clinical Hospital
City
Lviv
State/Province
Kharkiv Governorate
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
KZ "Dnipropetrovska oblasna dytiacha klinichna likarnia" DOR
City
Dnipropetrovsk
State/Province
Tavria Okruha
ZIP/Postal Code
49100
Country
Ukraine
Individual Site Status
Active, not recruiting
Facility Name
Birmingham Children's Hospital
City
Birmingham
ZIP/Postal Code
B4 6NH
Country
United Kingdom
Individual Site Status
Withdrawn
Facility Name
Great Ormond Street Hospital For Children; Neurology
City
London
ZIP/Postal Code
WC1N 3JH
Country
United Kingdom
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Qualified researchers may request access to individual patient level data through the clinical study data request platform (www.clinicalstudydatarequest.com). Further details on Roche's criteria for eligible studies are available here (https://clinicalstudydatarequest.com/Study-Sponsors/Study-Sponsors-Roche.aspx). For further details on Roche's Global Policy on Sharing of Clinical Study Information and how to request access to related clinical study documents, see here (https://www.roche.com/research_and_development/who_we_are_how_we_work/clinical_trials/our_commitment_to_data_sharing.htm)
Learn more about this trial
A Study To Evaluate Safety And Efficacy Of Ocrelizumab In Comparison With Fingolimod In Children And Adolescents With Relapsing-Remitting Multiple Sclerosis
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