Last updated: 04/22/2025 13:30:10
BENLYSTA® Special Drug Use Investigation
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: BENLYSTA for intravenous injection / subcutaneous injection Special Drug Use Investigation
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Change from Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI)
Timeframe: Baseline and up to 52 weeks
Change from Baseline in Physician's Global Assessment (PGA) score
Timeframe: Baseline and up to 52 weeks
Change from Baseline in Lupus Impact Tracker score
Timeframe: Baseline and up to 52 weeks
Number of subjects with abnormal change in laboratory parameters
Timeframe: Baseline and up to 52 weeks
Number of subjects with adverse events (AE) and serious adverse events (SAE)
Timeframe: Up to 52 weeks
Number of subjects with adverse drug reactions (ADR) of events defined as a priority study matter
Timeframe: Up to 52 weeks
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
600
Primary completion date:
2025-26-06
Observational study model:
Case-Only
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
January 2018 to June 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable
Accepts healthy volunteers
No
- 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.
- N/A
Inclusion and 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
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Recruiting
Actual primary completion date
Not applicable
Actual study completion date
Not applicable
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Additional information
Not applicable
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