The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric subjects with RRMS, as compared with a disease-modifying treatment and to assess health outcomes and evolution of disability. The primary objective of Part 2 is to evaluate the long-term safety of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306. The secondary objective of Part 2 is to describe the long-term MS outcomes of BG00012 in subjects who completed Week 96 in Part 1 of Study 109MS306.
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Proportion of Participants Free of New/Newly Enlarging T2 Hyperintense Lesions on Brain MRI Scans
Timeframe: At week 96
Number of Participants That Experience Adverse Events (AEs) or Serious Adverse Events (SAEs)
Timeframe: Up to 7 years
Number of Participants Who Discontinue Study Treatment due to an AE
Timeframe: Up to 7 years