BENLYSTA® Special Drug Use Investigation
該当なし
完了
NCT03370263
| 対象疾患 | Systemic Lupus Erythematosus |
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| 相 | 該当なし |
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| スポンサー | GlaxoSmithKline |
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| ステータス | 完了 |
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| 参加者数 | 1,514 名 |
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| 介入（薬剤） | Benlysta |
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| 開始日 | 2018年1月15日 |
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| 完了日 | 2025年7月31日 |
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| 結果公開日 | 2026年5月18日 |
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概要
The objective of this study is to collect and assess the information about long-term safety and effectiveness of Benlysta for intravenous injection and Benlysta for subcutaneous injection (hereinafter referred to as "Benlysta") in daily clinical practice. The aim of conducting this drug use investigation (DUI) in all subjects until data are accumulated from a certain number of subjects after Benlysta being marketed, data will be collected on safety and effectiveness of Benlysta in an early stage and thereby to take the necessary measures for proper use of Benlysta. Approximately 600 subjects will be enrolled in to this study. The observation period per subject will be 52 weeks from the start of Benlysta administration. BENLYSTA is the registered trademark of GlaxoSmithKline (GSK) group of companies.
Number of Participants With Adverse Drug Reactions (ADRs)
From the start of the study intervention (Day 1) up to maximum of 3 years · Participants
| Benlysta IV | 107 Participants |
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| Benlysta SC | 110 Participants |
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| Benlysta Switched From IV to SC or SC to IV | 47 Participants |
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| Benlysta IV or SC (Initial Route of Administration Unknown) | 0 Participants |
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Number of Participants With Serious ADR of Events Defined as a Priority Study Matter
From the start of the study intervention (Day 1) up to maximum of 3 years · Participants
| Benlysta IV | 3 Participants |
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| Benlysta SC | 0 Participants |
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| Benlysta Switched From IV to SC or SC to IV | 0 Participants |
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| Benlysta IV or SC (Initial Route of Administration Unknown) | 0 Participants |
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| Benlysta IV | 27 Participants |
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| Benlysta SC | 24 Participants |
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Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24
Baseline (Day 0) and Week 24 · Scores on a Scale
| Benlysta IV | -2.5 ± 4.8 Scores on a Scale |
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| Benlysta SC | -2.8 ± 4.3 Scores on a Scale |
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| Benlysta Switched From IV to SC or SC to IV | -2.8 ± 4.3 Scores on a Scale |
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| Benlysta IV or SC (Initial Route of Administration Unknown) | -4.0 ± NA Scores on a Scale |
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