BENLYSTA® Special Drug Use Investigation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2018-01-15

Study Completion Date

2025-06-26

Brief Summary

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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.

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Detailed Description

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Conditions

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Systemic Lupus Erythematosus

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Benlysta intravenous (IV)

This arm will include subjects who will receive Benlysta IV. Observation period per subject will be for 52 weeks from start of Benlysta administration.

Benlysta

Intervention Type DRUG

Benlysta will be administered intravenously or subcutaneously.

Benlysta subcutaneous (SC)

This arm will include subjects who will receive BENLYSTA SC. Observation period per subject will be for 52 weeks from start of Benlysta administration.

Benlysta

Intervention Type DRUG

Benlysta will be administered intravenously or subcutaneously.

Interventions

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Benlysta

Benlysta will be administered intravenously or subcutaneously.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* The study will include all subjects to whom Benlysta is administered. In addition, among subjects who start administration after launch, those to whom Benlysta has already administered before the conclusion of the contract and those who has already started administration at diagnosis, because of hospital transfer, etc. will be included as well.