BENLYSTA® Special Drug Use Investigation
Launched by GLAXOSMITHKLINE · Dec 6, 2017
Trial Information
Current as of November 14, 2025
Recruiting
Keywords
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.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Hiroshima, Japan
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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