BENLYSTA® Special Drug Use Investigation

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Systemic Lupus Erythematosus

Treatments: Drug: Benlysta

Study type: Observational

Funder types: Industry

Identifiers

NCT03370263

207735

Details and patient eligibility

About

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.

Enrollment: 1,514 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

• N/A

Trial design

1,514 participants in 2 patient groups

Benlysta intravenous (IV)

Description:

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

Treatment:

Drug: Benlysta

Benlysta subcutaneous (SC)

Description:

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

Treatment:

Drug: Benlysta