BENLYSTA® Special Drug Use Investigation

  • STATUS
    Recruiting
  • End date
    Jun 26, 2025
  • participants needed
    600
  • sponsor
    GlaxoSmithKline
Updated on 13 February 2022
benlysta

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.

Details
Condition Systemic Lupus Erythematosus
Treatment BENLYSTA
Clinical Study IdentifierNCT03370263
SponsorGlaxoSmithKline
Last Modified on13 February 2022

Eligibility

Yes No Not Sure

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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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