Systemic Lupus ErythematosusNCT03370263

BENLYSTA® Special Drug Use Investigation

An observational study of Systemic Lupus Erythematosus, run by GlaxoSmithKline at 1 site in Japan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Any age
Conditions the study is for: Systemic Lupus Erythematosus
What is being tested?: Benlysta
Type of treatment: Injection or infusion
How many people: 1,514 participants
Where: 1 siteJapan
Study dates: 15 Jan 2018to 31 Jul 2025
Phase: Observational
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Study population: 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.

Who may be able to join

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.

Who cannot join

Trial locations and contacts

1 site in 1 country.

Japan1 site

GSK Investigational Site
Hiroshima, 730-0001

Other trials in Japan

About this study

Official title: BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation

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.

Conditions: Systemic Lupus Erythematosus
Being tested: Benlysta
Keywords: Benlysta, systemic lupus erythematosus, safety, efficacy
Medical subject headings: Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

BenlystaDrug
Benlysta was administered

Study groups in NCT03370263
Study group	Role	What they receive
Benlysta intravenous (IV)		Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen. Receives: Drug: Benlysta
Benlysta subcutaneous (SC)		Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen. Receives: Drug: Benlysta
Benlysta switched from IV to SC or SC to IV		Participants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV during the study. Receives: Drug: Benlysta
Benlysta IV or SC (Initial route of administration unknown)		Participants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm. Receives: Drug: Benlysta

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Adverse Drug Reactions (ADRs)
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
Measured: 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
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Following serious ADRs were considered as priority study matter: 1. Serious hypersensitivity, 2. Serious infections (including tuberculosis, pneumonia, pneumocystis pneumonia, sepsis, and opportunistic infection), 3. Reactivation of hepatitis B virus, 4. Progressive multifocal leukoencephalopathy, 5. Interstitial pneumonitis, 6. Malignant tumor, 7. Depression and events related to suicide/self-injury.
Measured: 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
The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline (Day 0) and Week 24
Change From Baseline in SELENA SLEDAI Score at Week 52
The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline (Day 0) and Week 52
Change From Baseline in Lupus Impact Tracker Score at Week 24
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.
Measured: Baseline (Day 0) and Week 24
Change From Baseline in Lupus Impact Tracker Score at Week 52
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.
Measured: Baseline (Day 0) and Week 52
Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline (Day 0) and Week 24
Change From Baseline in PGA Score at Week 52
The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline (Day 0) and Week 52
Percent Change From Baseline in Mean Daily Steroid Dose at Week 4
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 4
Percent Change From Baseline in Mean Daily Steroid Dose at Week 8
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 8
Percent Change From Baseline in Mean Daily Steroid Dose at Week 12
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 12
Percent Change From Baseline in Mean Daily Steroid Dose at Week 16
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 16
Percent Change From Baseline in Mean Daily Steroid Dose at Week 20
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 20
Percent Change From Baseline in Mean Daily Steroid Dose at Week 24
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 24
Percent Change From Baseline in Mean Daily Steroid Dose at Week 28
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 28
Percent Change From Baseline in Mean Daily Steroid Dose at Week 32
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 32
Percent Change From Baseline in Mean Daily Steroid Dose at Week 36
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 36
Percent Change From Baseline in Mean Daily Steroid Dose at Week 40
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 40
Percent Change From Baseline in Mean Daily Steroid Dose at Week 44
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 44
Percent Change From Baseline in Mean Daily Steroid Dose at Week 48
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 48
Percent Change From Baseline in Mean Daily Steroid Dose at Week 52
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Measured: Baseline (Day 0) and Week 52
Number of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) Response Criteria at Week 24
LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score <=1 (33 millimeter); (4) corticosteroid dose <=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.
Measured: At Week 24
Number of Participants Who Achieved LLDAS Response Criteria at Week 52
LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score <=1 (33 millimeter); (4) corticosteroid dose <=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.
Measured: At Week 52
Change From Baseline in Blood Levels of Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody at Week 24
Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline (Day 0) and Week 24
Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52
Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: 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
Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: 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
Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline (Day 0) and Week 52
Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 24
Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline (Day 0) and Week 24
Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 52
Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline (Day 0) and Week 52
Change From Baseline in Urine Protein/Creatinine Ratio at Week 24
Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline (Day 0) and Week 24
Change From Baseline in Urine Protein/Creatinine Ratio at Week 52
Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Measured: Baseline (Day 0) and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

15 Jan 201831 Jul 2025

First posted12 Dec 2017
Study start15 Jan 2018
Primary completion31 Jul 2025
Study completion31 Jul 2025

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Systemic Lupus ErythematosusStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Case only
Time perspective: Prospective
Enrolment: 1,514 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03370263
Sponsor's protocol ID: 207735
Status last verified: Apr 2026
First submitted: 6 Dec 2017
Last updated: 18 May 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

Okamoto N, Fujii T, Atsumi T, Abe A, Takahashi N, Tamura N, Nakajima A, Nakajima A, Nakayamada S, Nishida K, Matsuno H, Asamura T, Koyano M, Hayashi A, Yoshida M, Noda D, Kaneko N, Saito S, Takagi M, Tanaka S, Takeuchi T, Tanaka Y, Kuwana M. Safety of intravenous and subcutaneous belimumab in Japanese patients with systemic lupus erythematosus: Final analysis of data from an all-case post-marketing surveillance study. Mod Rheumatol. 2026 Aug 19:roag066. doi: 10.1093/mr/roag066. Online ahead of print.
PubMed 42616068

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Systemic Lupus Erythematosus trials

Study at a glance

From the registry record, last updated by the sponsor on 18 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: BENLYSTA for Intravenous Injection / Subcutaneous Injection Special Drug Use Investigation
ClinicalTrials.gov ID: NCT03370263
Acronym / sponsor ID: 207735
Conditions: Systemic Lupus Erythematosus
Keywords: Benlysta, systemic lupus erythematosus, safety, efficacy
Study type: Observational
Recruitment status: Completed
Enrolment: 1,514 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 15 Jan 2018 (actual)
Primary completion: 31 Jul 2025 (actual)
Study completion: 31 Jul 2025 (actual)
First posted: 12 Dec 2017 (actual)
Results: Posted 18 May 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Observational model: Case only
Time perspective: Prospective
Number of arms: 4

Arm	Type	Receives
Benlysta intravenous (IV)	–	Drug: BenlystaParticipants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
Benlysta subcutaneous (SC)	–	Drug: BenlystaParticipants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
Benlysta switched from IV to SC or SC to IV	–	Drug: BenlystaParticipants with SLE received Benlysta for 52 weeks as a part of their treatment regimen, where initial administration was IV but switched to SC, or where the initial administration was SC but switched to IV during the study.
Benlysta IV or SC (Initial route of administration unknown)	–	Drug: BenlystaParticipants with SLE received Benlysta via IV or SC administration for 52 weeks as a part of their treatment regimen. It was unknown whether the initial administration was IV or SC for participants in this arm.

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult
Study population: 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.

Key inclusion criteria (1 listed)

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.

Key exclusion criteria (1 listed)

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
BenlystaBenlysta was administered	Drug	Benlysta IV or SC (Initial route of administration unknown), Benlysta intravenous (IV), Benlysta subcutaneous (SC), Benlysta switched from IV to SC or SC to IV

Primary outcome

Number of Participants With Adverse Drug Reactions (ADRs)
Time frame: From the start of the study intervention (Day 1) up to maximum of 3 years
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function.
Number of Participants With Serious ADR of Events Defined as a Priority Study Matter
Time frame: From the start of the study intervention (Day 1) up to maximum of 3 years
ADR is defined as a response to a drug which is noxious and unintended, and which occurred at doses normally used in human for the prophylaxis, diagnosis, or therapy of disease, or for the modifications of physiological function. Following serious ADRs were considered as priority study matter: 1. Serious hypersensitivity, 2. Serious infections (including tuberculosis, pneumonia, pneumocystis pneumonia, sepsis, and opportunistic infection), 3. Reactivation of hepatitis B virus, 4. Progressive multifocal leukoencephalopathy, 5. Interstitial pneumonitis, 6. Malignant tumor, 7. Depression and events related to suicide/self-injury.
Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24
Time frame: Baseline (Day 0) and Week 24
The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in SELENA SLEDAI Score at Week 52
Time frame: Baseline (Day 0) and Week 52
The SELENA-SLEDAI score is a cumulative and weighted index for assessing systemic lupus erythematosus (SLE) disease activity in participants with SLE. It consists of 24 disease descriptors related to signs and symptoms, laboratory tests, and physician's assessment across 9 organ systems. Each descriptor is assigned a weighted score (8 descriptors with a weight of 8 each, 6 descriptors with a weight of 4 each, 7 descriptors with a weight of 2 each, and 3 descriptors with a weight of 1 each) which is added up if the descriptor is observed during a visit or within the preceding 10 days. The total score ranges from 0 (no disease activity) to 105 (all 24 descriptors present simultaneously). A higher score indicates a more significant degree of disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Lupus Impact Tracker Score at Week 24
Time frame: Baseline (Day 0) and Week 24
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.
Change From Baseline in Lupus Impact Tracker Score at Week 52
Time frame: Baseline (Day 0) and Week 52
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives. Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points. Lower the lupus impact score, less impact lupus is having on life of participant. Total score was derived by adding up scores of all 10 items. Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life). Higher score indicates greater impact of lupus on quality of life.
Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
Time frame: Baseline (Day 0) and Week 24
The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in PGA Score at Week 52
Time frame: Baseline (Day 0) and Week 52
The PGA is used to assess the participant's current disease activity by investigator. It was collected on a 10 centimeter (cm) visual analogue scale (VAS). The score ranges from 0 (no activity) to 3 (severe activity). Lower score means no disease activity, higher score means severe disease activity. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 4
Time frame: Baseline (Day 0) and Week 4
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 8
Time frame: Baseline (Day 0) and Week 8
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 12
Time frame: Baseline (Day 0) and Week 12
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 16
Time frame: Baseline (Day 0) and Week 16
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 20
Time frame: Baseline (Day 0) and Week 20
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 24
Time frame: Baseline (Day 0) and Week 24
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 28
Time frame: Baseline (Day 0) and Week 28
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 32
Time frame: Baseline (Day 0) and Week 32
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 36
Time frame: Baseline (Day 0) and Week 36
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 40
Time frame: Baseline (Day 0) and Week 40
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 44
Time frame: Baseline (Day 0) and Week 44
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 48
Time frame: Baseline (Day 0) and Week 48
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Percent Change From Baseline in Mean Daily Steroid Dose at Week 52
Time frame: Baseline (Day 0) and Week 52
Mean daily steroid dose was calculated based on the prednisolone equivalent dose. The average dose over the 7 days prior to and including the assessment date was used as mean daily steroid dose. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value. Percent change from Baseline was calculated by dividing change from Baseline value by Baseline value and multiplying it by 100.
Number of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) Response Criteria at Week 24
Time frame: At Week 24
LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score <=1 (33 millimeter); (4) corticosteroid dose <=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.
Number of Participants Who Achieved LLDAS Response Criteria at Week 52
Time frame: At Week 52
LLDAS was defined as a state which, if sustained, was associated with a low likelihood of adverse outcome, considering disease activity and medication safety. The LLDAS response criteria were: (1) Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) less than equal to (<=)4 and no major active organ involvement (renal, central nervous system, cardiopulmonary, vasculitis, and pyrexia) and without hemolytic anemia or active gastrointestinal lesions; (2) no new signs or symptoms as compared to the last SELENA-SLEDAI assessment; (3) PGA score <=1 (33 millimeter); (4) corticosteroid dose <=7.5 milligram (mg)/day at time of assessment; and (5) use of the same immunosuppressant as compared with prior medication. No unapproved immunosuppressant drugs like rituximab, anifrolumab, ustekinumab, or baricitinib were used as concomitant medications.
Change From Baseline in Blood Levels of Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody at Week 24
Time frame: Baseline (Day 0) and Week 24
Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52
Time frame: Baseline (Day 0) and Week 52
Blood samples were collected for anti-dsDNA antibody biomarker analysis. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 24
Time frame: Baseline (Day 0) and Week 24
Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 52
Time frame: Baseline (Day 0) and Week 52
Blood samples were collected from participants to assess C3 and C4 levels. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 24
Time frame: Baseline (Day 0) and Week 24
Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 52
Time frame: Baseline (Day 0) and Week 52
Blood samples were collected from participants to assess CH50 concentrations. CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function. Low CH50 levels can be associated with certain infections. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Urine Protein/Creatinine Ratio at Week 24
Time frame: Baseline (Day 0) and Week 24
Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.
Change From Baseline in Urine Protein/Creatinine Ratio at Week 52
Time frame: Baseline (Day 0) and Week 52
Urine samples were collected from participants to assess Urine Protein/Creatinine Ratio. It is a test that estimates how much protein is being excreted in urine, normalized to creatinine. It's commonly used to assess kidney function and detect proteinuria. Baseline was considered as Day 0 of the study. Change from Baseline was defined as value at the indicated time point minus Baseline value.

Results and safety

Results posted to the registry on 18 May 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Benlysta IV	543	361
Benlysta SC	661	462
Benlysta Switched From IV to SC or SC to IV	308	270
Benlysta IV or SC (Initial Route of Administration Unknown)	2	1

Primary outcome: Number of Participants With Adverse Drug Reactions (ADRs)

Time frame: From the start of the study intervention (Day 1) up to maximum of 3 years. Count of participants. Unit: Participants

Measure	Benlysta IV n = 543	Benlysta SC n = 661	Benlysta Switched From IV to SC or SC to IV n = 308	Benlysta IV or SC (Initial Route of Administration Unknown) n = 2
Value	107	110	47	0

Population analysed: Safety Analysis Population included participants with locked case report forms (CRFs) and who do not correspond to criteria for exclusion from safety analysis set.

Primary outcome: Number of Participants With Serious ADR of Events Defined as a Priority Study Matter

Time frame: From the start of the study intervention (Day 1) up to maximum of 3 years. Count of participants. Unit: Participants

Measure	Benlysta IV n = 543	Benlysta SC n = 661	Benlysta Switched From IV to SC or SC to IV n = 308
Serious Hypersensitivity	3	0	0
Serious infections	27	24	9
Reactivation of hepatitis B virus	1	0	0
Progressive Multifocal Leukoencephalopathy	0	0	0
Interstitial Pneumonia	0	0	0
Malignant tumor	4	2	3
Depression and events related to suicide/self-injury	1	1	1

Population analysed: Safety Analysis Population included participants with locked CRFs and who do not correspond to criteria for exclusion from safety analysis set.

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

Time frame: Baseline (Day 0) and Week 24. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Benlysta IV n = 358	Benlysta SC n = 450	Benlysta Switched From IV to SC or SC to IV n = 204	Benlysta IV or SC (Initial Route of Administration Unknown) n = 1
Value	-2.5 (4.8)	-2.8 (4.3)	-2.8 (4.3)	-4.0 (NA)

Population analysed: Effectiveness Analysis Population included participants in the safety analysis set and do not correspond to criteria for exclusion from the efficacy analysis set. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field.

Primary outcome: Change From Baseline in SELENA SLEDAI Score at Week 52

Time frame: Baseline (Day 0) and Week 52. Mean (Standard Deviation). Unit: Scores on a Scale

Measure	Benlysta IV n = 304	Benlysta SC n = 342	Benlysta Switched From IV to SC or SC to IV n = 172	Benlysta IV or SC (Initial Route of Administration Unknown) n = 0
Value	-3.1 (5.1)	-3.6 (5.3)	-3.2 (5.6)	–

Population analysed: Effectiveness Analysis Population. Only those participants who were measured and analyzed (i.e., contributed to data reported in the table) were included in the Overall Number of Participants Analyzed field. Data could not be collected for the 'Benlysta IV or SC (Initial route of administration unknown)' arm because no participants were evaluable for this arm. Therefore, the Overall Number of Participants Analyzed is zero (N=0).

Adverse events

Time frame: All-cause mortality, non-serious adverse events (SAEs) and SAEs were collected from the start of the study intervention (Day 1) up to maximum of 3 years. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Benlysta IV	101 of 543 (18.6%)	154 of 543 (28.4%)	4 of 543
Benlysta SC	91 of 661 (13.8%)	155 of 661 (23.4%)	4 of 661
Benlysta Switched From IV to SC or SC to IV	43 of 308 (14%)	87 of 308 (28.2%)	2 of 308
Benlysta IV or SC (Initial Route of Administration Unknown)	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): Data have not been disclosed for the Lupus Impact Tracker (LIT) score outcome measures because the data cannot be reported externally at this time due to pending validation and copyright authorization by the copyright holder, although LIT assessments were collected at Baseline and Weeks 24 and 52. The data for pre-specified LIT outcome measures are anticipated to be disclosed by November 2027.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 42616068Okamoto N, Fujii T, Atsumi T, Abe A, Takahashi N, Tamura N, Nakajima A, Nakajima A, Nakayamada S, Nishida K, Matsuno H, Asamura T, Koyano M, Hayashi A, Yoshida M, Noda D, Kaneko N, Saito S, Takagi M, Tanaka S, Takeuchi T, Tanaka Y, Kuwana M. Safety of intravenous and subcutaneous belimumab in Japanese patients with systemic lupus erythematosus: Final analysis of data from an all-case post-marketing surveillance study. Mod Rheumatol. 2026 Aug 19:roag066. doi: 10.1093/mr/roag066. Online ahead of print.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Systemic Lupus Erythematosus, run by GlaxoSmithKline at 1 site in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 May 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Adverse Drug Reactions (ADRs) (time frame: From the start of the study intervention (Day 1) up to maximum of 3 years). The study lists 31 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03370263, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 May 2026.