Long Term Extension Study to Assess the Safety and Efficacy of Filgotinib in Adults With Rheumatoid Arthritis

3상 완료 NCT03025308

대상 질환	Rheumatoid Arthritis
임상 단계	3상
스폰서	Alfasigma S.p.A.
상태	완료
참여자 수	2,731 명
중재(약물)	Filgotinib, Placebo to match filgotinib
시작일	2017년 2월 28일
완료일	2025년 5월 16일
결과 공개일	2026년 7월 27일

요약

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
Filgotinob 200 mg: Without Prior Filgotinob Exposure	300 Participants
Filgotinib 100 mg: With Prior Filgotinib Exposure	769 Participants
Filgotinib 100 mg: Without Prior Filgotinib Exposure	283 Participants
Filgotinib 200 mg: With Prior Filgotinib Exposure	288 Participants
Filgotinob 200 mg: Without Prior Filgotinob Exposure	74 Participants

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
Filgotinob 200 mg: Without Prior Filgotinob Exposure	98 Participants
Filgotinib 100 mg: With Prior Filgotinib Exposure	274 Participants
Filgotinib 100 mg: Without Prior Filgotinib Exposure	106 Participants
Filgotinib 200 mg: With Prior Filgotinib Exposure	49 Participants
Filgotinob 200 mg: Without Prior Filgotinob Exposure	16 Participants

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
Filgotinob 200 mg: Without Prior Filgotinob Exposure	60 Participants
Filgotinib 100 mg: With Prior Filgotinib Exposure	165 Participants
Filgotinib 100 mg: Without Prior Filgotinib Exposure	60 Participants
Filgotinib 200 mg: With Prior Filgotinib Exposure	86 Participants
Filgotinob 200 mg: Without Prior Filgotinob Exposure	29 Participants

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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전체 임상

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