Clinical Research Directory

BENLYSTA® Special Drug Use Investigation

Sponsor: GlaxoSmithKline

Summary

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.

Official title: BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation

Key Details

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Interventions

Locations (1)