Last updated: 01/30/2026 14:10:14

BENLYSTA® Special Drug Use Investigation

GSK study ID
207735
See study documents
Clinicaltrials.gov ID
NCT03370263
See results summary
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: 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:

Number of participants with adverse drug reactions (ADRs)

Timeframe: From the start of the study intervention (Day 1) up to maximum of 3 years

Number of participants with Serious ADR of events defined as a priority study matter

Timeframe: From the start of the study intervention (Day 1) up to maximum of 3 years

Change from Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24

Timeframe: Baseline (Day 0) and Week 24

Change from Baseline in SELENA SLEDAI Score at Week 52

Timeframe: Baseline (Day 0) and Week 52

Change from Baseline in Lupus Impact Tracker Score at Week 24

Timeframe: Baseline (Day 0) and Week 24

Change from Baseline in Lupus Impact Tracker Score at Week 52

Timeframe: Baseline (Day 0) and Week 52

Change from Baseline in Physician's Global Assessment (PGA) score at Week 24

Timeframe: Baseline (Day 0) and Week 24

Change from Baseline in PGA score at Week 52

Timeframe: Baseline (Day 0) and Week 52

Percent Change from Baseline in Mean daily steroid dose at Week 4

Timeframe: Baseline (Day 0) and Week 4

Percent Change from Baseline in Mean daily steroid dose at Week 8

Timeframe: Baseline (Day 0) and Week 8

Percent Change from Baseline in Mean daily steroid dose at Week 12

Timeframe: Baseline (Day 0) and Week 12

Percent Change from Baseline in Mean daily steroid dose at Week 16

Timeframe: Baseline (Day 0) and Week 16

Percent Change from Baseline in Mean daily steroid dose at Week 20

Timeframe: Baseline (Day 0) and Week 20

Percent Change from Baseline in Mean daily steroid dose at Week 24

Timeframe: Baseline (Day 0) and Week 24

Percent Change from Baseline in Mean daily steroid dose at Week 28

Timeframe: Baseline (Day 0) and Week 28

Percent Change from Baseline in Mean daily steroid dose at Week 32

Timeframe: Baseline (Day 0) and Week 32

Percent Change from Baseline in Mean daily steroid dose at Week 36

Timeframe: Baseline (Day 0) and Week 36

Percent Change from Baseline in Mean daily steroid dose at Week 40

Timeframe: Baseline (Day 0) and Week 40

Percent Change from Baseline in Mean daily steroid dose at Week 44

Timeframe: Baseline (Day 0) and Week 44

Percent Change from Baseline in Mean daily steroid dose at Week 48

Timeframe: Baseline (Day 0) and Week 48

Percent Change from Baseline in Mean daily steroid dose at Week 52

Timeframe: Baseline (Day 0) and Week 52

Number of Participants who achieved Lupus Low Disease Activity State (LLDAS) response criteria at Week 24

Timeframe: At Week 24

Number of Participants who achieved LLDAS response criteria at Week 52

Timeframe: At Week 52

Change from Baseline in blood levels of Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) antibody at Week 24

Timeframe: Baseline (Day 0) and Week 24

Change from Baseline in blood levels of Anti-dsDNA antibody at Week 52

Timeframe: Baseline (Day 0) and Week 52

Change from Baseline in blood levels of complement component-3 (C3) and complement component-4 (C4) at Week 24

Timeframe: Baseline (Day 0) and Week 24

Change from Baseline in blood levels of complement component-3 (C3) and complement component-4 (C4) at Week 52

Timeframe: Baseline (Day 0) and Week 52

Change from Baseline in blood levels of Complement Hemolytic Activity at 50% (CH50) at Week 24

Timeframe: Baseline (Day 0) and Week 24

Change from Baseline in blood levels of Complement Hemolytic Activity at 50% (CH50) at Week 52

Timeframe: Baseline (Day 0) and Week 52

Change from Baseline in Urine Protein/creatinine ratio at Week 24

Timeframe: Baseline (Day 0) and Week 24

Change from Baseline in Urine Protein/creatinine ratio at Week 52

Timeframe: Baseline (Day 0) and Week 52

Secondary outcomes:
Not applicable
Interventions:
  • Drug: Benlysta
    • Enrollment:
    1514
    Primary completion date:
    2025-26-09
    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 September 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)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Hiroshima, Japan, 730-0001
    Status
    Recruiting
    Contact us

    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
    2025-26-09
    Actual study completion date
    2025-26-09

    Plain language summaries

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

    Additional information about the trial

    Not applicable
    Participate in clinical trial
    Access to clinical trial data by researchers
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