Investigation of Benlysta for treating systemic lupus erythematosus
BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation
This study is testing how well Benlysta works and how safe it is for people with systemic lupus erythematosus over a year of treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 600 (estimated) |
| Sex | All |
| Sponsor | GlaxoSmithKline Industry-sponsored |
| Locations | 1 site (Hiroshima) |
| Trial ID | NCT03370263 on ClinicalTrials.gov |
What this trial studies
This study aims to collect and evaluate long-term safety and effectiveness data for Benlysta, administered both intravenously and subcutaneously, in patients with systemic lupus erythematosus. The observational study will enroll approximately 600 subjects, with each participant being observed for 52 weeks following the initiation of Benlysta treatment. The goal is to gather real-world evidence on the drug's performance in clinical practice to ensure its proper use. Data will be collected from patients receiving Benlysta in various settings to assess its impact on their condition.
Who should consider this trial
Good fit: Ideal candidates for this study are patients diagnosed with systemic lupus erythematosus who are starting treatment with Benlysta.
Not a fit: Patients who are not receiving Benlysta or those with conditions other than systemic lupus erythematosus may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide valuable insights into the long-term safety and efficacy of Benlysta, potentially improving treatment strategies for patients with systemic lupus erythematosus.
How similar studies have performed: Other studies have shown positive outcomes with Benlysta in treating systemic lupus erythematosus, indicating that this investigation builds on existing knowledge.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hiroshima
- GSK Investigational Site — Hiroshima, Japan (Recruiting)
Study contacts
- Study coordinator: US GSK Clinical Trials Call Center
- Email: GSKClinicalSupportHD@gsk.com
- Phone: 877-379-3718
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.