BENLYSTA® 特殊药物使用调查
2026年4月24日 更新者：GlaxoSmithKline
BENLYSTA 用于静脉注射/皮下注射特殊药物使用调查
本研究的目的是收集和评估日常临床实践中静脉注射用贝利司他和皮下注射用贝利司他（以下简称“贝利司他”）的长期安全性和有效性信息。
对所有受试者进行药物使用调查（DUI）的目的是在 Benlysta 上市后从一定数量的受试者中积累数据，尽早收集有关 Benlysta 安全性和有效性的数据，从而采取必要的措施正确使用 Benlysta。
大约 600 名受试者将被纳入这项研究。
从 Benlysta 给药开始，每个受试者的观察期为 52 周。
BENLYSTA 是葛兰素史克 (GSK) 集团公司的注册商标。
研究概览
研究类型
观察性的
注册 (实际的)
1514
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Hiroshima、日本、730-0001
- GSK Investigational Site
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 孩子
- 成人
- 年长者
接受健康志愿者
不
取样方法
概率样本
研究人群
该研究将包括接受 Benlysta 治疗的所有受试者。
此外，在上市后开始给药的受试者中，合同签订前已经给药的受试者和诊断时因转院等原因已经开始给药的受试者也将包括在内。
描述
纳入标准：
- 该研究将包括接受 Benlysta 治疗的所有受试者。 此外，在上市后开始给药的受试者中，合同签订前已经给药的受试者和诊断时因转院等原因已经开始给药的受试者也将包括在内。
排除标准：
- 不适用
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：仅案例
- 时间观点：预期
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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.
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Benlysta was administered
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Benlysta subcutaneous (SC)
Participants with SLE received Benlysta via subcutaneous (SC) administration for 52 weeks as a part of their treatment regimen.
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Benlysta was administered
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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.
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Benlysta was administered
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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.
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Benlysta was administered
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Number of Participants With Adverse Drug Reactions (ADRs)
大体时间：From the start of the study intervention (Day 1) up to maximum of 3 years
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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.
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From the start of the study intervention (Day 1) up to maximum of 3 years
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Number of Participants With Serious ADR of Events Defined as a Priority Study Matter
大体时间：From the start of the study intervention (Day 1) up to maximum of 3 years
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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.
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From the start of the study intervention (Day 1) up to maximum of 3 years
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Change From Baseline in Safety of Estrogens in Lupus Erythematosus National Assessment Systemic Lupus Erythematosus Disease Activity Index (SELENA SLEDAI) Score at Week 24
大体时间：Baseline (Day 0) and Week 24
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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.
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Baseline (Day 0) and Week 24
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Change From Baseline in SELENA SLEDAI Score at Week 52
大体时间：Baseline (Day 0) and Week 52
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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.
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Baseline (Day 0) and Week 52
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Change From Baseline in Lupus Impact Tracker Score at Week 24
大体时间：Baseline (Day 0) and Week 24
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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.
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Baseline (Day 0) and Week 24
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Change From Baseline in Lupus Impact Tracker Score at Week 52
大体时间：Baseline (Day 0) and Week 52
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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.
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Baseline (Day 0) and Week 52
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Change From Baseline in Physician's Global Assessment (PGA) Score at Week 24
大体时间：Baseline (Day 0) and Week 24
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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.
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Baseline (Day 0) and Week 24
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Change From Baseline in PGA Score at Week 52
大体时间：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.
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Baseline (Day 0) and Week 52
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 4
大体时间：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.
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Baseline (Day 0) and Week 4
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 8
大体时间：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.
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Baseline (Day 0) and Week 8
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 12
大体时间：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.
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Baseline (Day 0) and Week 12
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 16
大体时间：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.
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Baseline (Day 0) and Week 16
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 20
大体时间：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.
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Baseline (Day 0) and Week 20
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 24
大体时间：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.
|
Baseline (Day 0) and Week 24
|
|
Percent Change From Baseline in Mean Daily Steroid Dose at Week 28
大体时间：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.
|
Baseline (Day 0) and Week 28
|
|
Percent Change From Baseline in Mean Daily Steroid Dose at Week 32
大体时间：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.
|
Baseline (Day 0) and Week 32
|
|
Percent Change From Baseline in Mean Daily Steroid Dose at Week 36
大体时间：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.
|
Baseline (Day 0) and Week 36
|
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 40
大体时间：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.
|
Baseline (Day 0) and Week 40
|
|
Percent Change From Baseline in Mean Daily Steroid Dose at Week 44
大体时间：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.
|
Baseline (Day 0) and Week 44
|
|
Percent Change From Baseline in Mean Daily Steroid Dose at Week 48
大体时间：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.
|
Baseline (Day 0) and Week 48
|
|
Percent Change From Baseline in Mean Daily Steroid Dose at Week 52
大体时间：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.
|
Baseline (Day 0) and Week 52
|
|
Number of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) Response Criteria at Week 24
大体时间：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.
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At Week 24
|
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Number of Participants Who Achieved LLDAS Response Criteria at Week 52
大体时间：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.
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At Week 52
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Change From Baseline in Blood Levels of Anti-double-stranded Deoxyribonucleic Acid (Anti-dsDNA) Antibody at Week 24
大体时间：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.
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Baseline (Day 0) and Week 24
|
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Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52
大体时间：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.
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Baseline (Day 0) and Week 52
|
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Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 24
大体时间：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.
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Baseline (Day 0) and Week 24
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Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 52
大体时间：Baseline (Day 0) and Week 52
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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.
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Baseline (Day 0) and Week 52
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Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 24
大体时间：Baseline (Day 0) and Week 24
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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.
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Baseline (Day 0) and Week 24
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Change From Baseline in Blood Levels of Complement Hemolytic Activity at 50% (CH50) at Week 52
大体时间：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.
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Baseline (Day 0) and Week 52
|
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Change From Baseline in Urine Protein/Creatinine Ratio at Week 24
大体时间：Baseline (Day 0) and Week 24
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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.
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Baseline (Day 0) and Week 24
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Change From Baseline in Urine Protein/Creatinine Ratio at Week 52
大体时间：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.
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Baseline (Day 0) and Week 52
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 研究主任：GSK Clinical Trials、GlaxoSmithKline
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2018年1月15日
初级完成 (实际的)
2025年7月31日
研究完成 (实际的)
2025年7月31日
研究注册日期
首次提交
2017年12月6日
首先提交符合 QC 标准的
2017年12月6日
首次发布 (实际的)
2017年12月12日
研究记录更新
最后更新发布 (实际的)
2026年5月18日
上次提交的符合 QC 标准的更新
2026年4月24日
最后验证
2026年4月1日
更多信息
与本研究相关的术语
其他研究编号
- 207735
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
Benlysta的临床试验
-
Leiden University Medical CenterGlaxoSmithKline尚未招聘
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GlaxoSmithKline招聘中硬皮病，系统性 | 系统性硬化症相关间质性肺病美国, 澳大利亚, 法国, 西班牙, 希腊, 以色列, 日本, 英国, 芬兰, 中国, 阿根廷, 意大利, 巴西, 丹麦, 比利时, 墨西哥, 德国, 韩国
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Human Genome Sciences Inc.GlaxoSmithKline完全的系统性红斑狼疮香港, 台湾, 大韩民国, 印度, 智利, 阿根廷, 菲律宾, 哥伦比亚, 巴西, 罗马尼亚, 澳大利亚, 秘鲁, 俄罗斯联邦
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Assistance Publique - Hôpitaux de Paris完全的