An observational study in Systemic Lupus Erythematosus, sponsored by GlaxoSmithKline. Completed at 1 site in Japan. Per ClinicalTrials.gov, last updated 2026-05-18.
Sponsored by GlaxoSmithKline · Observational
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Among 43 studies in Lupus Erythematosus, Systemic by GlaxoSmithKline — 1 open to participants now, 4 under way, none of them phase 3. Lupus Erythematosus, Systemic · GlaxoSmithKline.
Among the 43 studies in Lupus Erythematosus, Systemic by GlaxoSmithKline, this one is one of 2 that started in 2018, is one of 6 observational ones, and was the 33rd registered.
1,210 studies on the registry are indexed under Lupus Erythematosus, Systemic; 406 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →1 of the 43 studies in Lupus Erythematosus, Systemic by GlaxoSmithKline is open now, in 9 countries. Recruiting first, the newest first:
GlaxoSmithKline · Sites in Argentina, Brazil, France and 6 more countries
Ages 18–70
By country, each count listing its studies:
Of the 284 Lupus Erythematosus, Systemic studies recruiting now, 93 (33%) set no upper age limit and 161 (57%) stop at 75 or younger; 54 take children under 18; 33 take healthy volunteers.
This study: all sexes · no healthy volunteers.
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43 studies; the count open now beside each. This study's row is marked.
First in 2002; this study’s year is marked. 2 started in 2018.
By drug class, each counting the studies that test any of its medicines:
This study's enrollment of 1,514 is above the median of 150 across 281 observational studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 87 across the 36 interventional studies, 605 across the 6 observational. Of the 36 that completed or were terminated, 26 (72%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
1 of the studies in Lupus Erythematosus, Systemic by GlaxoSmithKline that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06411249GlaxoSmithKlineA Study Describing the Efficacy and Safety of Belimumab Administered in Adult Participants With Early Systemic Lupus Erythematosus (SLE) | 2027-06-29 |
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Among the 43 studies in Lupus Erythematosus, Systemic by GlaxoSmithKline, from their registry updates:
This tab as a report to print or save as PDF → With an account.
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.
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.
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Exclusion Criteria:
Participants with systemic lupus erythematosus (SLE) received Benlysta via intravenous (IV) administration for 52 weeks as a part of their treatment regimen.
Drug: Benlysta
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
Drug: Benlysta
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.
Drug: Benlysta
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.
Drug: Benlysta
Benlysta was administered
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Baseline (Day 0) and Week 52
This Special Drug Use Investigation was conducted under routine clinical practice in Japan as a non-interventional/observational study. No treatment arms were assigned by protocol; route of administration (intravenous \[IV\] or subcutaneous \[SC\]) was determined by treating physicians in real world care. Protocol confirms observational conduct in actual use conditions and does not define any randomized or assigned arms.
| Milestone | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Started | 543 | 661 | 308 | 2 |
| Completed | 361 | 462 | 270 | 1 |
| Not completed | 182 | 199 | 38 | 1 |
| Withdrew: Adverse event | 51 | 55 | 11 | 0 |
| Withdrew: Withdrawal by subject | 33 | 39 | 8 | 0 |
| Withdrew: Pregnancy | 5 | 4 | 0 | 0 |
| Withdrew: Physician decision | 16 | 11 | 4 | 0 |
| Withdrew: Lost to follow-up | 9 | 13 | 3 | 0 |
| Withdrew: Lack of efficacy | 67 | 47 | 10 | 0 |
| Withdrew: Death | 1 | 1 | 0 | 0 |
| Withdrew: Other | 0 | 29 | 2 | 1 |
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.
| Participants | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Number of Participants With Adverse Drug Reactions (ADRs) | 107 | 110 | 47 | 0 |
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.
| Participants | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Serious Hypersensitivity | 3 | 0 | 0 | 0 |
| Serious infections | 27 | 24 | 9 | 0 |
| Reactivation of hepatitis B virus | 1 | 0 | 0 | 0 |
| Progressive Multifocal Leukoencephalopathy | 0 | 0 | 0 | 0 |
| Interstitial Pneumonia | 0 | 0 | 0 | 0 |
| Malignant tumor | 4 | 2 | 3 | 0 |
| Depression and events related to suicide/self-injury | 1 | 1 | 1 | 0 |
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.
| Scores on a Scale | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24 | -2.5 ± 4.8 | -2.8 ± 4.3 | -2.8 ± 4.3 | -4.0 ± NA |
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.
| Scores on a Scale | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Change From Baseline in SELENA SLEDAI Score at Week 52 | -3.1 ± 5.1 | -3.6 ± 5.3 | -3.2 ± 5.6 | — |
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.
Results for this outcome have not been posted.
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.
Results for this outcome have not been posted.
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.
| Scores on a Scale | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24 | -0.44 ± 0.56 | -0.51 ± 0.55 | -0.44 ± 0.58 | — |
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.
| Scores on a Scale | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Change From Baseline in PGA Score at Week 52 | -0.64 ± 0.65 | -0.62 ± 0.63 | -0.53 ± 0.64 | — |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 4 | -1.57 ± 37.30 | -1.61 ± 25.35 | -0.70 ± 3.56 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 8 | -3.46 ± 34.00 | -2.26 ± 26.21 | -1.15 ± 4.92 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 12 | -2.97 ± 42.70 | -2.81 ± 26.71 | -1.59 ± 7.05 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 16 | -4.59 ± 35.68 | -3.48 ± 27.19 | -0.70 ± 22.93 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 20 | -5.15 ± 36.90 | -3.90 ± 27.53 | -2.50 ± 6.95 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 24 | -4.36 ± 46.43 | -4.07 ± 27.94 | -2.61 ± 6.91 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 28 | -6.15 ± 39.51 | -4.24 ± 25.22 | -2.61 ± 7.70 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 32 | -6.59 ± 40.41 | -4.73 ± 29.43 | -2.67 ± 8.66 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 36 | -6.85 ± 40.58 | -5.01 ± 29.61 | -3.04 ± 8.01 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 40 | -5.61 ± 50.19 | -5.15 ± 29.83 | -3.17 ± 8.16 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 44 | -7.20 ± 41.60 | -5.40 ± 30.05 | -3.44 ± 7.96 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 48 | -7.43 ± 41.87 | -5.03 ± 22.21 | -3.63 ± 7.98 | 0.00 ± NA |
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 | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Percent Change From Baseline in Mean Daily Steroid Dose at Week 52 | -8.27 ± 45.01 | -3.98 ± 7.57 | -3.89 ± 7.80 | 0.00 ± NA |
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.
| Participants | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Number of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) Response Criteria at Week 24 | 48 | 68 | 34 | — |
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.
| Participants | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Number of Participants Who Achieved LLDAS Response Criteria at Week 52 | 36 | 57 | 37 | — |
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.
| International Units per milliliter | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Change From Baseline in Blood Levels of Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody at Week 24 | 36.590 ± 72.145 | 27.721 ± 53.206 | 31.765 ± 62.527 | 5.000 ± NA |
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.
| International Units per milliliter | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52 | 30.984 ± 58.594 | 26.890 ± 95.331 | 28.346 ± 66.919 | 5.000 ± NA |
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.
| Milligram per deciliter | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| C3 | 82.57 ± 25.01 | 82.08 ± 23.56 | 83.79 ± 24.22 | 96.00 ± NA |
| C4 | 18.26 ± 9.22 | 16.88 ± 8.12 | 17.15 ± 7.94 | 25.00 ± NA |
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.
| Milligram per deciliter | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| C3 | 85.45 ± 24.67 | 85.05 ± 23.84 | 85.16 ± 22.27 | 97.00 ± NA |
| C4 | 18.71 ± 8.48 | 17.34 ± 8.10 | 17.38 ± 7.84 | 40.00 ± NA |
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.
| Units per milliliter | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 24 | 39.03 ± 15.20 | 38.14 ± 13.19 | 39.85 ± 14.57 | — |
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.
| Units per milliliter | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 52 | 39.60 ± 14.91 | 38.55 ± 13.47 | 39.73 ± 14.62 | — |
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.
| Ratio | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Change From Baseline in Urine Protein/Creatinine Ratio at Week 24 | 0.25200 (0.07610 to 1.25000) | 0.17000 (0.09000 to 0.48000) | 0.12000 (0.06000 to 0.56000) | — |
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.
| Ratio | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Change From Baseline in Urine Protein/Creatinine Ratio at Week 52 | 0.15000 (0.07000 to 0.55000) | 0.15000 (0.07800 to 0.50000) | 0.10000 (0.06000 to 0.30630) | 0.00000 (NA to NA) |
Collected over 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. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Benlysta IV | 4/543 (0.7%) | 101/543 (18.6%) | 154/543 (28.4%) |
| Benlysta SC | 4/661 (0.6%) | 91/661 (13.8%) | 155/661 (23.4%) |
| Benlysta Switched From IV to SC or SC to IV | 2/308 (0.6%) | 43/308 (14%) | 87/308 (28.2%) |
| Benlysta IV or SC (Initial Route of Administration Unknown) | 0/2 (0%) | 0/2 (0%) | 0/2 (0%) |
| Event | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| CellulitisInfections and infestations | 8/543 | 4/661 | 4/308 | 0/2 |
| Renal impairmentRenal and urinary disorders | 8/543 | 2/661 | 2/308 | 0/2 |
| Systemic lupus erythematosusMusculoskeletal and connective tissue disorders | 6/543 | 2/661 | 1/308 | 0/2 |
| Enteritis infectiousInfections and infestations | 1/543 | 0/661 | 3/308 | 0/2 |
| PneumoniaInfections and infestations | 5/543 | 5/661 | 0/308 | 0/2 |
| Cytomegalovirus infectionInfections and infestations | 5/543 | 1/661 | 2/308 | 0/2 |
| OsteonecrosisMusculoskeletal and connective tissue disorders | 1/543 | 6/661 | 0/308 | 0/2 |
| Herpes zosterInfections and infestations | 4/543 | 2/661 | 2/308 | 0/2 |
| AnaemiaBlood and lymphatic system disorders | 4/543 | 0/661 | 0/308 | 0/2 |
| Spinal compression fractureInjury, poisoning and procedural complications | 4/543 | 0/661 | 0/308 | 0/2 |
| Event | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) |
|---|---|---|---|---|
| Upper respiratory tract inflammationRespiratory, thoracic and mediastinal disorders | 20/543 | 14/661 | 3/308 | 0/2 |
| NasopharyngitisInfections and infestations | 18/543 | 16/661 | 8/308 | 0/2 |
| PyrexiaGeneral disorders | 16/543 | 18/661 | 3/308 | 0/2 |
| Herpes zosterInfections and infestations | 13/543 | 10/661 | 8/308 | 0/2 |
| InfluenzaInfections and infestations | 6/543 | 9/661 | 8/308 | 0/2 |
| Injection site painGeneral disorders | 0/543 | 8/661 | 8/308 | 0/2 |
| HeadacheNervous system disorders | 9/543 | 9/661 | 6/308 | 0/2 |
| DiarrhoeaGastrointestinal disorders | 9/543 | 9/661 | 4/308 | 0/2 |
| MalaiseGeneral disorders | 7/543 | 7/661 | 5/308 | 0/2 |
| NauseaGastrointestinal disorders | 4/543 | 4/661 | 4/308 | 0/2 |
| Age, Customized(Participants) | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) | Total |
|---|---|---|---|---|---|
| 13 to 85 years | 543 | 661 | 308 | 2 | 1514 |
| Sex: Female, Male(Participants) | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) | Total |
|---|---|---|---|---|---|
| Female | 470 | 597 | 287 | 1 | 1355 |
| Male | 73 | 64 | 21 | 1 | 159 |
| Race and Ethnicity Not Collected(Participants) | Benlysta IV | Benlysta SC | Benlysta Switched From IV to SC or SC to IV | Benlysta IV or SC (Initial Route of Administration Unknown) | Total |
|---|---|---|---|---|---|
| Count of participants | — | — | — | — | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jan 2018 to primary completion in Jul 2025, 90 months.
Results were first posted in May 2026, 9 months after primary completion.
Of 112 observational studies under Lupus Erythematosus, Systemic, half reached primary completion within 64 months of starting (the median), counting those still running; a quarter within 34 and three quarters within 126. This study's 90 months is above that.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Apr 2026. You cannot join it, but the record below documents what was studied.
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Lupus Erythematosus, Systemic →