Clinical trial NCT03370263: BENLYSTA® Special Drug Use Investigation
Official title: BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Systemic Lupus Erythematosus
Keywords: Benlysta, systemic lupus erythematosus, safety, efficacy
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-12-12
Enrollment: 600
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.


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

Primary outcomes:
measure: 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
measure: Change from Baseline in Physician's Global Assessment (PGA) score
timeFrame: Baseline and up to 52 weeks
measure: Change from Baseline in Lupus Impact Tracker score
timeFrame: Baseline and up to 52 weeks
measure: Number of subjects with abnormal change in laboratory parameters
timeFrame: Baseline and up to 52 weeks
measure: Number of subjects with adverse events (AE) and serious adverse events (SAE)
timeFrame: Up to 52 weeks
measure: Number of subjects with adverse drug reactions (ADR) of events defined as a priority study matter
timeFrame: Up to 52 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Hiroshima
country: Japan
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: