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- Ensayo clínico NCT03370263
Investigación de uso de drogas especiales de BENLYSTA®
24 de abril de 2026 actualizado por: GlaxoSmithKline
BENLYSTA para inyección intravenosa/inyección subcutánea Investigación especial de uso de drogas
El objetivo de este estudio es recopilar y evaluar la información sobre la seguridad y eficacia a largo plazo de Benlysta para inyección intravenosa y Benlysta para inyección subcutánea (en adelante, "Benlysta") en la práctica clínica diaria.
El objetivo de realizar esta investigación de uso de drogas (DUI) en todos los sujetos hasta que se acumulen datos de un cierto número de sujetos después de la comercialización de Benlysta, se recopilarán datos sobre la seguridad y eficacia de Benlysta en una etapa temprana y, por lo tanto, se tomarán las medidas necesarias. para el uso adecuado de Benlysta.
Aproximadamente 600 sujetos se inscribirán en este estudio.
El período de observación por sujeto será de 52 semanas desde el inicio de la administración de Benlysta.
BENLYSTA es la marca registrada del grupo de empresas GlaxoSmithKline (GSK).
Descripción general del estudio
Tipo de estudio
De observación
Inscripción (Actual)
1514
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Hiroshima, Japón, 730-0001
- GSK Investigational Site
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
No
Método de muestreo
Muestra de probabilidad
Población de estudio
El estudio incluirá a todos los sujetos a los que se administre Benlysta.
Además, entre los sujetos que inician la administración después del lanzamiento, también se incluirán aquellos a los que ya se les haya administrado Benlysta antes de la celebración del contrato y aquellos que ya hayan iniciado la administración en el momento del diagnóstico, por traslado hospitalario, etc.
Descripción
Criterios de inclusión:
- El estudio incluirá a todos los sujetos a los que se administre Benlysta. Además, entre los sujetos que inician la administración después del lanzamiento, también se incluirán aquellos a los que ya se les haya administrado Benlysta antes de la celebración del contrato y aquellos que ya hayan iniciado la administración en el momento del diagnóstico, por traslado hospitalario, etc.
Criterio de exclusión:
- N / A
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Solo caso
- Perspectivas temporales: Futuro
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number of Participants With Adverse Drug Reactions (ADRs)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline (Day 0) and Week 52
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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 52
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 4
Periodo de tiempo: Baseline (Day 0) and Week 4
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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
Periodo de tiempo: Baseline (Day 0) and Week 8
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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
Periodo de tiempo: Baseline (Day 0) and Week 12
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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
Periodo de tiempo: Baseline (Day 0) and Week 16
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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
Periodo de tiempo: Baseline (Day 0) and Week 20
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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
Periodo de tiempo: Baseline (Day 0) and Week 24
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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
Periodo de tiempo: Baseline (Day 0) and Week 28
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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 28
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 32
Periodo de tiempo: 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
Periodo de tiempo: Baseline (Day 0) and Week 36
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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
Periodo de tiempo: Baseline (Day 0) and Week 40
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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
Periodo de tiempo: Baseline (Day 0) and Week 44
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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 44
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 48
Periodo de tiempo: 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.
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Baseline (Day 0) and Week 48
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Percent Change From Baseline in Mean Daily Steroid Dose at Week 52
Periodo de tiempo: 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.
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Baseline (Day 0) and Week 52
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Number of Participants Who Achieved Lupus Low Disease Activity State (LLDAS) Response Criteria at Week 24
Periodo de tiempo: At Week 24
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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
Periodo de tiempo: At Week 52
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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
Periodo de tiempo: 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
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Change From Baseline in Blood Levels of Anti-dsDNA Antibody at Week 52
Periodo de tiempo: Baseline (Day 0) and Week 52
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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 52
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Change From Baseline in Blood Levels of Complement Component-3 (C3) and Complement Component-4 (C4) at Week 24
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: Baseline (Day 0) and Week 52
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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 52
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Change From Baseline in Urine Protein/Creatinine Ratio at Week 24
Periodo de tiempo: 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
Periodo de tiempo: Baseline (Day 0) and Week 52
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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 52
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: GSK Clinical Trials, GlaxoSmithKline
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de enero de 2018
Finalización primaria (Actual)
31 de julio de 2025
Finalización del estudio (Actual)
31 de julio de 2025
Fechas de registro del estudio
Enviado por primera vez
6 de diciembre de 2017
Primero enviado que cumplió con los criterios de control de calidad
6 de diciembre de 2017
Publicado por primera vez (Actual)
12 de diciembre de 2017
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
18 de mayo de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
24 de abril de 2026
Última verificación
1 de abril de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- 207735
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .
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