BENLYSTA® Special Drug Use Investigation

단계 해당 없음 완료 NCT03370263

요약

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

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

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

BENITIONS에서 보기 ClinicalTrials.gov 원문 보기

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