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Search / Trial NCT03370263

BENLYSTA® Special Drug Use Investigation

Launched by GLAXOSMITHKLINE · Dec 6, 2017

Trial Information

Current as of November 14, 2025

Recruiting

Keywords

Benlysta, Systemic Lupus Erythematosus, Safety, Efficacy

ClinConnect Summary

This clinical trial, called the BENLYSTA® Special Drug Use Investigation, is looking at the long-term safety and effectiveness of a medication called Benlysta for people with systemic lupus erythematosus, which is a chronic condition that can affect various parts of the body. The goal is to gather important information about how well Benlysta works and if it has any side effects when used in everyday clinical practice. The study aims to involve around 600 participants, who will be observed for 52 weeks after starting the treatment.

To be eligible for this study, participants must be individuals who are set to receive Benlysta, including those who have already started treatment before the study began or those who are transitioning from other care. There are no specific exclusion criteria mentioned, meaning that most people who meet the inclusion criteria can participate. If you join the study, you can expect regular check-ins and evaluations regarding your health and how you're responding to the medication. This study is important for ensuring that Benlysta is used safely and effectively for patients with lupus.

Gender

ALL

Eligibility criteria

  • 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

About Glaxosmithkline

GlaxoSmithKline (GSK) is a global healthcare company dedicated to improving the quality of human life by enabling people to do more, feel better, and live longer. With a strong focus on research and development, GSK specializes in pharmaceuticals, vaccines, and consumer health products. The company is committed to advancing innovative therapies and preventive measures across various therapeutic areas, including respiratory, oncology, immunology, and infectious diseases. GSK's collaborative approach and rigorous clinical trial processes underscore its dedication to delivering safe and effective healthcare solutions that meet the needs of patients worldwide.

Locations

Hiroshima, Japan

Patients applied

0 patients applied

Trial Officials

GSK Clinical Trials

Study Director

GlaxoSmithKline

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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