Last updated: 04/24/2026 14:20:16

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

Finalized

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

Observational study model:

Case-Only

Primary completion date:

2025-31-07

Time perspective:

Prospective

Clinical publications:

Not applicable

Medical condition

Systemic Lupus Erythematosus

Product

belimumab

Collaborators

Not applicable

Study date(s)

January 2018 to July 2025

Type

Observational

Phase

Not applicable

Participation criteria

Sex

Female & Male

Age

Not applicable

Accepts healthy volunteers

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.

Trial location(s)

Location

Status

Location

GSK Investigational Site

Hiroshima, Japan, 730-0001

Status

Study Complete

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

Finalized

Actual primary completion date

2025-31-07

Actual study completion date

2025-31-07

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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Access to clinical trial data by researchers

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