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 120 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:
1. Between 10 to \<18 years of age (i.e., have not yet had their 18th birthday) at randomization
2. Diagnosis of multiple sclerosis
3. EDSS score of 0 to 5.5, inclusive
4. 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:
1. Participants with progressive MS
2. Participants with an active, chronic disease of the immune system other than MS
3. Participants meeting the definition of ADEM
4. Participants with severe cardiac disease or significant findings on the screening ECG.
5. Participants with severe renal insufficiency
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Caba,Buenos Aires,C1181ach,Argentina
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Parkville,Victoria,3052,Australia
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Wien,1090,Austria
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Esneux,4130,Belgium
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Gent,9000,Belgium
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Porto Alegre,RS,90430-001,Brazil
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Sao Paulo,SP,05403-000,Brazil
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Curitiba,PR,81210-310,Brazil
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Montreal,Quebec,H3a 2b4,Canada
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Montreal,Quebec,H3t 1c5,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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Le Kremlin Bicetre,94275,France
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Montpellier,34295,France
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Strasbourg,67000,France
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Freiburg,79106,Germany
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Gottingen,37075,Germany
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Berlin,13353,Germany
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Bochum,44791,Germany
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Erlangen,91054,Germany
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Guatemala,01015,Guatemala
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Kolkata,West Bengal,700017,India
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New Delhi,Delhi,110 017,India
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Kochi,Kerala,682041,India
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Lucknow,Uttar Pradesh,226014,India
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Petach Tikva,49202,Israel
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Milano,MI,20132,Italy
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Roma,RM,00165,Italy
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Napoli,80131,Italy
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Riga,Lv-1004,Latvia
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Mexico,Distrito Federal,06720,Mexico
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Ciudad de Mexico,Distrito Federal,06700,Mexico
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Gdansk,80 952,Poland
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Poznan,60-355,Poland
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Lodz,93-338,Poland
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Warsaw,04 730,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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Belgrade,11000,Serbia
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Bratislava,833 40,Slovakia
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Sevilla,Andalucia,41009,Spain
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Oviedo,Asturias,33011,Spain
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Baracaldo,Vizcaya,48903,Spain
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Madrid,28034,Spain
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Tainan,70403,Taiwan
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Taipei,10002,Taiwan
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Istanbul,TUR,34098,Turkey
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Izmir,35575,Turkey
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Kocaeli,41380,Turkey
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Samsun,55139,Turkey
Childrens Hospital Los Angeles .
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Los Angeles,California,90027,United States
Jonathan Santoro
WA Uni School Of Med Main Center
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Saint Louis,Missouri,63110,United States
Soe Mar
Childrens Healthcare Of Atlanta .
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Atlanta,Georgia,30322,United States
Grace Gombolay
Childrens Hospital of Philadelphia .
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Philadelphia,Pennsylvania,19104 4399,United States
Amy Waldman
Uni of Louisville Clncl Trials Unit Novak Center
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Louisville,Kentucky,40202,United States
Michael Sweeney
Childrens National Medical Center .
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Washington,District of Columbia,20010,United States
Alexandra Kornbluh
Mayo Clinic - Rochester
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Rochester,Minnesota,55905,United States
Jan-Mendelt Tillema
Arkansas Childrens Hosp Rsch Inst .
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Little Rock,Arkansas,72202,United States
Virginia Erin Willis
Axiom Clinical Research of Florida
Recruiting
Tampa,Florida,33609,United States
Mark Cascione
Medical College of Wisconsin .
Recruiting
Milwaukee,Wisconsin,53226,United States
Ahmed Obeidat
Worldwide Contacts
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