Multiple Sclerosis Clinical Trial
Study to Evaluate the Efficacy and Safety of Dimethyl Fumarate (Tecfidera) and Peginterferon Beta-1a (Plegridy) for the Treatment of Relapsing-Remitting Multiple Sclerosis in Pediatric Participants
The main objective of the study is to evaluate the efficacy of dimethyl fumarate (Tecfidera) and peginterferon beta-1a (Plegridy), both compared with placebo, in pediatric participants with RRMS. The other objectives of this study are to evaluate the safety and tolerability of dimethyl fumarate and peginterferon beta-1a and to assess the effect of dimethyl fumarate and peginterferon beta-1a, both compared with placebo, on additional clinical and radiological measures of disease activity.
Participants will be randomized in a 1:2:2 ratio to receive the double-blind study treatment (Dimethyl Fumarate, Peginterferon Beta-1a, and placebo). Participants experiencing a confirmed relapse or disability progression or high lesion burden on MRI will have the option to discontinue the blinded study treatment and switch to an alternative therapy or open-label BG00012.
Key Inclusion Criteria:
Must have a diagnosis of RRMS as defined by the revised consensus definition for pediatric MS
Must have an EDSS score between 0.0 and 5.0.
Must have a body weight of ≥30 kg
Must have experienced ≥1 relapse in the 12 months prior to randomization (Day 1), or must have evidence of asymptomatic disease activity seen on MRI in the 6 months prior to randomization, or ≥2 relapses in the 24 months prior to randomization (Day 1). Relapse is defined as the occurrence of a clinical demyelination event regardless of whether the event is a first or subsequent demyelinating event.
Key Exclusion Criteria:
Participants having primary progressive, secondary progressive, or progressive RMS.
Disorders mimicking MS, such as other demyelinating disorders, systemic autoimmune disorders, metabolic disorders, and infectious disorders.
History of clinically significant cardiovascular, pulmonary, GI, hepatic, renal, endocrinologic, hematologic, immunologic, metabolic, dermatologic, growth, developmental, psychiatric (including depression), neurologic (other than MS), and/or other major disease and/or laboratory abnormality indicative thereof, that would preclude participation in a clinical study
Occurrence of an MS relapse within the 30 days prior to randomization (Day 1) and/or the subject has not stabilized from a previous relapse prior to randomization
NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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There are 6 Locations for this study
Raleigh North Carolina, 27607, United States
Medellín , , Colombia
Tallinn , 11315, Estonia
Budapest , 1083, Hungary
Ar-Ramtha , , Jordan
Seoul , 06351, Korea, Republic of
Petaling Jaya , , Malaysia
Seberang Jaya , , Malaysia
Guadalajara , , Mexico
Morelia , , Mexico
Santa Cruz , , Mexico
Dammam , , Saudi Arabia
Riyadh , , Saudi Arabia
Taipei , 10002, Taiwan
Taoyuan , 333, Taiwan
Bangkok , , Thailand
Manouba , , Tunisia
Monastir , , Tunisia
Sfax , , Tunisia
Tunis , , Tunisia
Ankara , , Turkey
Izmir , , Turkey
Samsun , , Turkey
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