Investigação de Uso de Medicamentos Especiais BENLYSTA®
24 de abril de 2026 atualizado por: GlaxoSmithKline
BENLYSTA para Injeção Intravenosa / Injeção Subcutânea Investigação do Uso de Medicamentos Especiais
O objetivo deste estudo é coletar e avaliar as informações sobre a segurança e eficácia a longo prazo de Benlysta para injeção intravenosa e Benlysta para injeção subcutânea (doravante denominado “Benlysta”) na prática clínica diária.
O objetivo de conduzir esta investigação de uso de drogas (DUI) em todos os indivíduos até que os dados sejam acumulados de um certo número de indivíduos após a comercialização de Benlysta, serão coletados dados sobre segurança e eficácia de Benlysta em um estágio inicial e, assim, para tomar as medidas necessárias para o uso adequado de Benlysta.
Aproximadamente 600 indivíduos serão incluídos neste estudo.
O período de observação por indivíduo será de 52 semanas a partir do início da administração de Benlysta.
BENLYSTA é uma marca registrada do grupo de empresas GlaxoSmithKline (GSK).
Visão geral do estudo
Status
Concluído
Condições
Intervenção / Tratamento
Tipo de estudo
Observacional
Inscrição (Real)
1514
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Locais de estudo
-
-
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Hiroshima, Japão, 730-0001
- GSK Investigational Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Método de amostragem
Amostra de Probabilidade
População do estudo
O estudo incluirá todos os indivíduos aos quais Benlysta é administrado.
Além disso, entre os sujeitos que iniciam a administração após o lançamento, também serão incluídos aqueles a quem Benlysta já tenha administrado antes da conclusão do contrato e aqueles que já iniciaram a administração no momento do diagnóstico, por transferência hospitalar, etc.
Descrição
Critério de inclusão:
- O estudo incluirá todos os indivíduos aos quais Benlysta é administrado. Além disso, entre os sujeitos que iniciam a administração após o lançamento, também serão incluídos aqueles a quem Benlysta já tenha administrado antes da conclusão do contrato e aqueles que já iniciaram a administração no momento do diagnóstico, por transferência hospitalar, etc.
Critério de exclusão:
- N / D
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Modelos de observação: Caso-somente
- Perspectivas de Tempo: Prospectivo
Coortes e Intervenções
Grupo / Coorte |
Intervenção / Tratamento |
|---|---|
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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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Number of Participants With Adverse Drug Reactions (ADRs)
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: Baseline (Day 0) and Week 52
|
Lupus impact tracker is 10-item patient reported outcome tool to measure impact of systemic lupus erythematosus or its treatment on participants' daily lives.
Each answer for items is marked from 0 (none of the time) to 4 (all of the time) points.
Lower the lupus impact score, less impact lupus is having on life of participant.
Total score was derived by adding up scores of all 10 items.
Total score ranges from 0 (less impact on daily life) to 40 (greater impact on daily life).
Higher score indicates greater impact of lupus on quality of life.
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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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
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Baseline (Day 0) and Week 24
|
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 28
Prazo: 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
|
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 32
Prazo: 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.
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Baseline (Day 0) and Week 32
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 36
Prazo: 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.
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Baseline (Day 0) and Week 36
|
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 40
Prazo: 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.
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Baseline (Day 0) and Week 40
|
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 44
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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.
|
Baseline (Day 0) and Week 24
|
|
Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52
Prazo: 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.
|
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
Prazo: 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
Prazo: Baseline (Day 0) and Week 52
|
Blood samples were collected from participants to assess C3 and C4 levels.
Baseline was considered as Day 0 of the study.
Change from Baseline was defined as value at the indicated time point minus Baseline value.
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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
Prazo: Baseline (Day 0) and Week 24
|
Blood samples were collected from participants to assess CH50 concentrations.
CH50 is a blood test that measures the overall activity of the complement system, a group of proteins crucial for the immune system's function.
Low CH50 levels can be associated with certain infections.
Baseline was considered as Day 0 of the study.
Change from Baseline was defined as value at the indicated time point minus Baseline value.
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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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: GSK Clinical Trials, GlaxoSmithKline
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de janeiro de 2018
Conclusão Primária (Real)
31 de julho de 2025
Conclusão do estudo (Real)
31 de julho de 2025
Datas de inscrição no estudo
Enviado pela primeira vez
6 de dezembro de 2017
Enviado pela primeira vez que atendeu aos critérios de CQ
6 de dezembro de 2017
Primeira postagem (Real)
12 de dezembro de 2017
Atualizações de registro de estudo
Última Atualização Postada (Real)
18 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
24 de abril de 2026
Última verificação
1 de abril de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 207735
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .