Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
Phase 3
Completed
NCT02283853
| Condition | Relapsing-Remitting Multiple Sclerosis |
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| Phase | Phase 3 |
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| Sponsor | Biogen |
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| Status | Completed |
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| Enrollment | 156 participants |
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| Interventions | dimethyl fumarate, Interferon β-1a |
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| Start date | Aug 28, 2014 |
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| Completion date | Jul 8, 2025 |
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| Results posted | May 19, 2026 |
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Summary
The main objectives of Part 1 are as follows: To evaluate the safety, tolerability, and efficacy of BG00012 in pediatric participants 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 participants 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 participants who completed Week 96 in Part 1 of Study 109MS306.
Part 1: Proportion of Participants Free of New or Newly Enlarging T2 Hyperintense Lesions on Brain Magnetic Resonance Imaging (MRI) Scans
At Week 96 · proportion of participants
| Part 1: BG00012 | 0.161 proportion of participants |
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| Part 1: Interferon β-1a | 0.049 proportion of participants |
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Part 2: Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
From Week 96 up to last follow-up visit (up to Week 340) · Participants
| Part 2: BG00012/ BG00012 | 49 Participants |
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| Part 2: IFN β-1a/ BG00012 | 31 Participants |
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| Part 2: BG00012/ BG00012 | 8 Participants |
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| Part 2: IFN β-1a/ BG00012 | 2 Participants |
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Part 2: Number of Participants Who Discontinued Study Treatment Due to an AE
From Week 96 up to last follow-up visit (up to Week 340) · Participants
| Part 2: BG00012/ BG00012 | 2 Participants |
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| Part 2: IFN β-1a/ BG00012 | 1 Participants |
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Open in BENITIONS
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