Study Description
Efficacy and safety of ofatumumab and siponimod compared to fingolimod in pediatric patients with multiple sclerosis
The study is divided into a Core Part and Extension Part. The Core Part is a 24-month, double-blind, triple dummy, randomized, 3-arm active-controlled in children/adolescent patients aged 10-17 years old with Multiple Sclerosis (MS). The Extension Part is 60-month (5 year) open label (except for first 12 weeks transition which will remain double-blind) treatment for patients who complete the Core Part of the study and meet all inclusion/exclusion criteria. The targeted enrollment is 180 participants with multiple sclerosis which will include at least 5 participants with body weight (BW) ≤40 kg and at least 5 participants with age 10 to 12 years in each of the ofatumumab and siponimod arms. There is a minimum 6 month follow up period for all participants (core and extension). Total duration of the study could be up to 7 years.
Interventions
Fingolimod
Fingolimod placebo
Ofatumumab
Ofatumumab placebo
Siponimod
Siponimod placebo
Eligibility Criteria
Inclusion Criteria:
Between 10 to <18 years of age (i.e., have not yet had their 18th birthday) at randomization
Diagnosis of multiple sclerosis
EDSS score of 0 to 5.5, inclusive
At least one MS relapse/attack during the previous year or two MS relapses in the previous two years prior or evidence of one or more new T2 lesions within 12 months
Exclusion Criteria:
Participants with progressive MS
Participants with an active, chronic disease of the immune system other than MS
Participants meeting the definition of ADEM
Participants with severe cardiac disease or significant findings on the screening ECG.
Participants with severe renal insufficiency
Study Location
Novartis Investigative Site
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Caba,Buenos Aires,C1181ACH,Argentina
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Parkville,Victoria,3052,Australia
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Vienna,1090,Austria
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Gent,9000,Belgium
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Esneux,4130,Belgium
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Curitiba,PR,81210-310,Brazil
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Sao Paulo,SP,05403-000,Brazil
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Porto Alegre,RS,90430-001,Brazil
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Montreal,Quebec,H3T 1C5,Canada
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Toronto,Ontario,M5G 1X8,Canada
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Montreal,Quebec,H3A 2B4,Canada
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Lo Barnechea,Santiago,7691236,Chile
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Zagreb,10000,Croatia
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Tallinn,11315,Estonia
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Strasbourg,67098,France
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Le Kremlin Bicetre,94275,France
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Montpellier,34295,France
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Berlin,13353,Germany
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Bochum,44791,Germany
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Gottingen,37075,Germany
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Erlangen,91054,Germany
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Freiburg,79106,Germany
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Guatemala,01015,Guatemala
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Kochi,Kerala,682041,India
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Lucknow,Uttar Pradesh,226014,India
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Kolkata,West Bengal,700017,India
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New Delhi,Delhi,110017,India
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Petach-Tikva,49202,Israel
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Napoli,80131,Italy
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Roma,RM,00165,Italy
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Milano,MI,20132,Italy
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Riga,LV-1004,Latvia
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Mexico,Distrito Federal,06720,Mexico
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Chihuahua,31203,Mexico
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Ciudad de Mexico,Distrito Federal,06700,Mexico
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Poznan,60-355,Poland
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Warsaw,04 730,Poland
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Gdansk,80 952,Poland
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Lodz,93-338,Poland
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Coimbra,3000-602,Portugal
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Lisboa,1169-050,Portugal
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Bucuresti,041914,Romania
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St Petersburg,190000,Russian Federation
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Belgrade,11000,Serbia
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Bratislava,833 40,Slovakia
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Oviedo,Asturias,33011,Spain
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Baracaldo,Vizcaya,48903,Spain
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Sevilla,Andalucia,41009,Spain
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Tainan,70403,Taiwan
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Taipei,10002,Taiwan
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Kaohsiung,83301,Taiwan
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Istanbul,TUR,34098,Turkey
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Samsun,55139,Turkey
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Izmir,35575,Turkey
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Kocaeli,41380,Turkey
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London,WC1N 1EH,United Kingdom
Childrens Hospital Los Angeles .
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Los Angeles,Fatima Menendez (401-413-2344) email: [email protected] -- Jonathan Santoro,90027 - California,United States
Providence St Vincent Med Center .
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Portland,(503-216-1234) -- Alison Christy,97225 - Oregon,United States
Childrens Hospital of Philadelphia .
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Philadelphia,Kat Gallison (215-590-1719) email: [email protected] -- Amy Waldman,19104 4399 - Pennsylvania,United States
Uni of Louisville Clncl Trials Unit Novak Center
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Louisville,Michael Sweeney,40202 - Kentucky,United States
Mayo Clinic - Rochester
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Rochester,Lexi DeLay (507-284-5689) email: [email protected] -- Jan-Mendelt Tillema,55905 - Minnesota,United States
Arkansas Childrens Hosp Rsch Inst .
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Little Rock,Kat Turbeville (+1 501 978 6413) email: [email protected] -- Virginia Erin Willis,72202 - Arkansas,United States
University of California San Diego
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San Diego,Sophie Zacharek (619-543-6102) email: [email protected] -- Jennifer Graves,92103 - California,United States
Medical College of Wisconsin .
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Milwaukee,Adriane Mueller (414-955-0619) email: [email protected] -- Ahmed Obeidat,53226 - Wisconsin,United States
Axiom Clinical Research of Florida
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Tampa,Fnu Madhuri (813-353-9613) email: [email protected] -- Mark Cascione,33609 - Florida,United States
University of Texas Southwestern Main Center
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Dallas,Tammy Ramm (214-648-2546) email: [email protected] -- Cynthia Wang,75390 - Texas,United States
Children's National Medical Center .
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Washington,Emily Mc Cracken (202-476-5000) email: [email protected] -- Alexandra Kornbluh,20010 - District of Columbia,United States
Washington Uni School of Med Main Center
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Saint Louis,Olga Novak (314-454-8293) email: [email protected] -- Soe Mar,63110 - Missouri,United States
Childrens Healthcare of Atlanta .
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Atlanta,Arpit Dosanjh (404-785-5437) email: [email protected] -- Grace Gombolay,30329 - Georgia,United States
Worldwide Contacts
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