Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis
第3相
完了
NCT03025308
| 対象疾患 | Rheumatoid Arthritis |
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| 相 | 第3相 |
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| スポンサー | Alfasigma S.p.A. |
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| ステータス | 完了 |
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| 参加者数 | 2,731 名 |
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| 介入（薬剤） | Filgotinib, Placebo to match filgotinib |
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| 開始日 | 2017年2月28日 |
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| 完了日 | 2025年5月16日 |
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| 結果公開日 | 2026年7月27日 |
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概要
The primary objective of this study is to evaluate the long-term safety and tolerability of filgotinib in participants who have completed one of the parent studies of filgotinib in rheumatoid arthritis (RA).
Number of Participants Who Reported Treatment-Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)
Day 1 to Week 376 (end of study) · Participants
| Filgotinib 200 mg: With Prior Filgotinib Exposure | 1071 Participants |
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| Filgotinob 200 mg: Without Prior Filgotinob Exposure | 300 Participants |
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| Filgotinib 100 mg: With Prior Filgotinib Exposure | 769 Participants |
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| Filgotinib 100 mg: Without Prior Filgotinib Exposure | 283 Participants |
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| Filgotinib 200 mg: With Prior Filgotinib Exposure | 288 Participants |
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| Filgotinob 200 mg: Without Prior Filgotinob Exposure | 74 Participants |
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Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Serum Chemistry Parameters
Day 1 to Week 376 (end of study) · Participants
| Filgotinib 200 mg: With Prior Filgotinib Exposure | 394 Participants |
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| Filgotinob 200 mg: Without Prior Filgotinob Exposure | 98 Participants |
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| Filgotinib 100 mg: With Prior Filgotinib Exposure | 274 Participants |
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| Filgotinib 100 mg: Without Prior Filgotinib Exposure | 106 Participants |
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| Filgotinib 200 mg: With Prior Filgotinib Exposure | 49 Participants |
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| Filgotinob 200 mg: Without Prior Filgotinob Exposure | 16 Participants |
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Number of Participants Who Reported Treatment-Emergent Graded Laboratory Abnormalities in Hematology Parameters
Day 1 to Week 376 (end of study) · Participants
| Filgotinib 200 mg: With Prior Filgotinib Exposure | 247 Participants |
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| Filgotinob 200 mg: Without Prior Filgotinob Exposure | 60 Participants |
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| Filgotinib 100 mg: With Prior Filgotinib Exposure | 165 Participants |
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| Filgotinib 100 mg: Without Prior Filgotinib Exposure | 60 Participants |
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| Filgotinib 200 mg: With Prior Filgotinib Exposure | 86 Participants |
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| Filgotinob 200 mg: Without Prior Filgotinob Exposure | 29 Participants |
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BENITIONS で見る
ClinicalTrials.gov の原文を見る
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