Phase 3 Efficacy and Safety Study of BG00012 in Pediatric Participants With Relapsing-Remitting Multiple Sclerosis (RRMS)
第3相
完了
NCT02283853
| 対象疾患 | Relapsing-Remitting Multiple Sclerosis |
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| 相 | 第3相 |
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| スポンサー | Biogen |
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| ステータス | 完了 |
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| 参加者数 | 156 名 |
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| 介入（薬剤） | dimethyl fumarate, Interferon β-1a |
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| 開始日 | 2014年8月28日 |
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| 完了日 | 2025年7月8日 |
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| 結果公開日 | 2026年5月19日 |
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概要
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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