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Clinical trial

BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation

ID
Name
207735
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.
Trial arms
Trial start
2018-01-15
Estimated PCD
2025-06-26
Trial end
2025-06-26
Status
Recruiting
Treatment
Benlysta
Benlysta will be administered intravenously or subcutaneously.
Arms:
Benlysta intravenous (IV), Benlysta subcutaneous (SC)
Size
600
Primary endpoint
Change from Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI)
Baseline and up to 52 weeks
Change from Baseline in Physician's Global Assessment (PGA) score
Baseline and up to 52 weeks
Change from Baseline in Lupus Impact Tracker score
Baseline and up to 52 weeks
Number of subjects with abnormal change in laboratory parameters
Baseline and up to 52 weeks
Number of subjects with adverse events (AE) and serious adverse events (SAE)
Up to 52 weeks
Number of subjects with adverse drug reactions (ADR) of events defined as a priority study matter
Up to 52 weeks
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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'CASE_ONLY', 'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'count': 600, 'type': 'ESTIMATED'}}
Updated at
2022-11-28

1 organization

1 product

1 indication

Product
Benlysta
Indication
Systemic Lupus Erythematosus
Organization
GlaxoSmithKline