Last updated: 07/12/2024 09:10:09
Benlysta pediatric special drug use investigation
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Recruiting
Recruiting
Trial overview
Official title: BENLYSTA for Intravenous Injection Pediatric 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 (IV) injection (hereinafter referred to as "Benlysta") in pediatric participants (aged <15 years) in daily clinical practice. The aim of conducting a drug use investigation (DUI) in all participants until data are accumulated from a certain number of participants after Benlysta being marketed, collect the data on safety and effectiveness of Benlysta in an early stage and thereby take the necessary measures for proper use of Benlysta. Approximately 115 participants will be enrolled in to this study. The observation period per participant will be 52 weeks from the start of Benlysta administration.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Number of participants with adverse drug reactions (ADRs)
Timeframe: Up to Week 52
Number of participants with severe ADRs
Timeframe: Up to Week 52
Incidence rate of ADRs and severe ADRs
Timeframe: Up to Week 52
Factors that potentially affect safety
Timeframe: Up to Week 52
Number of participants with ADRs defined as a priority study matter
Timeframe: Up to Week 52
Change from Baseline in safety of estrogens in lupus erythematosus national assessment (SELENA) systemic lupus erythematosus disease activity index (SLEDAI) at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in SELENA, SLEDAI at Week 52
Timeframe: Baseline and Week 52
Change from Baseline in physician's global assessment (PGA) score at Week 24
Timeframe: Baseline and Week 24
Change from Baseline in PGA score at Week 52
Timeframe: Baseline and Week 52
Number of participants with increase in daily dose of systemic steroids due to worsening of SLE
Timeframe: Up to Week 52
Number of participants with abnormal findings in laboratory parameters
Timeframe: Up to Week 52
Secondary outcomes:
Not applicable
Interventions:
Enrollment:
115
Primary completion date:
2025-25-06
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
November 2019 to June 2025
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable - 15 Years
Accepts healthy volunteers
No
- The study will include all pediatric participants to whom Benlysta is administered after approval for pediatric dosage.
- NA
Inclusion and exclusion criteria
Inclusion criteria:
- The study will include all pediatric participants to whom Benlysta is administered after approval for pediatric dosage.
Exclusion criteria:
- NA
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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