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.
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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