NCT03370263Completed
BENLYSTA® Special Drug Use Investigation
BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation
Source: ClinicalTrials.gov · Last updated 18 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1514 (actual)
- First submitted
- 6 Dec 2017
- Start date
- 15 Jan 2018
- Primary completion date
- 31 Jul 2025
- Lead sponsor
- GlaxoSmithKline
- Diseases
- Lupus (SLE)
- NCT number
- NCT03370263
What you commit to
- Study type: Observational
- Participants enrolled: 1514
- From 15 Jan 2018 to the primary completion date, 31 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other
- N/A
Who the study is looking for
- 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.
Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| GSK Investigational Site Coordinator of this site? Confirm its status | Hiroshima | Japan | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.