BENLYSTA® 特別薬物使用調査
2026年4月24日 更新者：GlaxoSmithKline
ベンリスタ静注・皮下注 特殊用途調査
本研究は、日常臨床におけるベンリスタ点滴静注剤及びベンリスタ皮下注剤（以下「ベンリスタ」という。）の長期安全性及び有効性に関する情報を収集し、評価することを目的としている。
この薬物使用調査（DUI）は、ベンリスタの発売後、一定数の被験者のデータが蓄積されるまで全被験者を対象に実施し、早期にベンリスタの安全性及び有効性に関するデータを収集し、必要な措置を講じることを目的としています。ベンリスタを正しくお使いいただくために。
約 600 人の被験者がこの研究に登録されます。
被験者当たりの観察期間はベンリスタ投与開始から52週間となります。
BENLYSTA は、GlaxoSmithKline (GSK) グループ企業の登録商標です。
調査の概要
研究の種類
観察的
入学 (実際)
1514
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
-
-
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Hiroshima、日本、730-0001
- GSK Investigational Site
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-
参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
いいえ
サンプリング方法
確率サンプル
調査対象母集団
この研究には、ベンリスタが投与されるすべての被験者が含まれます。
なお、発売後に投与を開始する対象者には、契約締結前に既にベンリスタの投与を行っている者や、転院等により診断時に既に投与を開始している者も含まれる。
説明
包含基準:
- この研究には、ベンリスタが投与されるすべての被験者が含まれます。 なお、発売後に投与を開始する対象者には、契約締結前に既にベンリスタの投与を行っている者や、転院等により診断時に既に投与を開始している者も含まれる。
除外基準:
- 該当なし
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：ケースのみ
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Number of Participants With Adverse Drug Reactions (ADRs)
時間枠：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
時間枠：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.
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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
時間枠：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.
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Baseline (Day 0) and Week 24
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Change From Baseline in SELENA SLEDAI Score at Week 52
時間枠：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.
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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
時間枠：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.
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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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
|
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 36
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：Baseline (Day 0) and Week 24
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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
|
|
Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52
時間枠：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
時間枠：Baseline (Day 0) and Week 24
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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 24
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Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 52
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
スポンサー
捜査官
- スタディディレクター：GSK Clinical Trials、GlaxoSmithKline
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始 (実際)
2018年1月15日
一次修了 (実際)
2025年7月31日
研究の完了 (実際)
2025年7月31日
試験登録日
最初に提出
2017年12月6日
QC基準を満たした最初の提出物
2017年12月6日
最初の投稿 (実際)
2017年12月12日
学習記録の更新
投稿された最後の更新 (実際)
2026年5月18日
QC基準を満たした最後の更新が送信されました
2026年4月24日
最終確認日
2026年4月1日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- 207735
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
いいえ
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
いいえ
米国FDA規制機器製品の研究
いいえ
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。
全身性エリテマトーデスの臨床試験
-
Beijing Immunochina Medical Science & Technology...まだ募集していません体系的なループスerythematosusを治療するのは困難です
Benlystaの臨床試験
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Human Genome Sciences Inc.GlaxoSmithKline完了全身性エリテマトーデス香港, 台湾, 大韓民国, インド, チリ, アルゼンチン, フィリピン, コロンビア, ブラジル, ルーマニア, オーストラリア, ペルー, ロシア連邦
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GlaxoSmithKline募集強皮症、全身性 | 全身性硬化症関連間質性肺疾患アメリカ, オーストラリア, フランス, スペイン, ギリシャ, イスラエル, 日本, イギリス, フィンランド, 中国, アルゼンチン, イタリア, ブラジル, デンマーク, ベルギー, メキシコ, ドイツ, 韓国