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
Condition: Multiple Sclerosis, Relapsing-Remitting
MeSH terms: Multiple Sclerosis; Multiple Sclerosis, Relapsing-Remitting; Sclerosis
Intervention: Dimethyl Fumarate; Peginterferon Beta-1a; Placebo
Intervention description: Administered as specified in the treatment arm.; Administered as specified in the treatment arm.; Administered as specified in the treatment arm.
Intervention MeSH terms: Dimethyl Fumarate
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 11.0
Sex: All
Minimum age: 10 Years
Maximum age: 17 Years
Healthy volunteers: No
Keywords: Pediatric, Multiple Sclerosis

Summary:

      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.
    

Eligibility criteria:

        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.