Last updated: 02/25/2025 10:10:15

A study to observe safety of BENLYSTA® administered in participants with Systemic Lupus Erythematosus (SLE)

GSK study ID
216984
See study documents
Clinicaltrials.gov ID
Not applicable
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

Official title: An open label, multi-centre, observational study to observe safety of Benlysta administered in Korean subjects with Systemic Lupus Erythematosus (SLE)
Trial description: This observational study aims to collect safety data on BENLYSTA administered in Korean participants with SLE used according to approved label in real-world practice. BENLYSTA is a registered trademark of GlaxoSmithKline (GSK) group of companies.
Primary purpose:
Treatment
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:

Number of participants with adverse events (AEs), adverse drug reactions (ADRs), serious adverse events (SAEs) and Serious adverse drug reactions (SADRs)

Timeframe: Up to 48 weeks

Factors that potentially affect safety of BENLYSTA

Timeframe: Up to 48 weeks

Secondary outcomes:
Not applicable
Interventions:
Not applicable
Enrollment:
300
Primary completion date:
2024-26-06
Observational study model:
Cohort
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Systemic Lupus Erythematosus
Product
belimumab
Collaborators
Not applicable
Study date(s)
July 2021 to June 2024
Type
Observational
Phase
4

Participation criteria

Sex
Female & Male
Age
18+ years
Accepts healthy volunteers
No
  • Inclusion criteria:
  • Treatment of Adult participants with active Systemic Lupus Erythematosus with auto-antibody positive under standard therapy.
Inclusion and exclusion criteria
Inclusion criteria:
  • Inclusion criteria:
  • Treatment of Adult participants with active Systemic Lupus Erythematosus with auto-antibody positive under standard therapy.
  • Participants who will administer BENLYSTA according to approval condition.
  • Participants who have agreed to participate and provide personal information in this study. Exclusion criteria:
  • Participants who have a history of anaphylaxis for compound of this BENLYSTA.
  • Participants who have an unfit history to participate of this study decided by Investigator.

Trial location(s)

Location
Status
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Location
GSK Investigational Site
Seoul, South Korea, 133-792
Status
Study Complete
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Location
GSK Investigational Site
Busan, South Korea, 49201
Status
Study Complete
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Location
GSK Investigational Site
Pusan, South Korea, 49241
Status
Study Complete
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Location
GSK Investigational Site
Daejeon, South Korea, 35233
Status
Study Complete
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Location
GSK Investigational Site
Jeonju, South Korea, 561-712
Status
Study Complete
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Location
GSK Investigational Site
Seoul, South Korea, 5030
Status
Study Complete
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Study documents

Protocol
Available language(s): English
Download document(s)
Statistical analysis plan
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Study complete
Actual primary completion date
2024-26-06
Actual study completion date
2024-26-06

Plain language summaries

Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.

Additional information about the trial

Not applicable
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