Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
3상
완료
NCT02283853
| 대상 질환 | Relapsing-Remitting Multiple Sclerosis |
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| 임상 단계 | 3상 |
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| 스폰서 | Biogen |
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| 상태 | 완료 |
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| 참여자 수 | 156 명 |
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| 중재(약물) | dimethyl fumarate, Interferon β-1a |
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| 시작일 | 2014년 8월 28일 |
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| 완료일 | 2025년 7월 8일 |
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| 결과 공개일 | 2026년 5월 19일 |
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요약
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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