Logro de LLDAS5 en pacientes con lupus eritematoso sistémico tratados con anifrolumab. (DAHLIA)
DAHLIA: Logro de un Nivel Bajo de Actividad de la Enfermedad Con una Dosis de Corticosteroides Menor o Igual a 5 mg (LLDAS5): un Estudio en Vida Real con Anifrolumab en Pacientes con Lupus Eritematoso Sistémico en Italia
This is an observational, multicenter, prospective study on patients with systemic lupus erythematosus treated with anifrolumab in Italy aimed at evaluating the achievement of LLDAS5
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
DAHLIA study aims to expand real-world evidence on anifrolumab role in clinical practice, specifically evaluating its effectiveness in achieving and maintenance of LLDAS with a dose of corticosteroids less than or equal to 5 mg/day (LLDAS5). Moreover it will provide data on corticosteroid tapering strategies. Additionally, will be also evaluated the Definitions Of Remission In SLE (DORIS) remission during the study period, as well as the depressive symptoms of these patients.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: AstraZeneca Clinical Study Information Center
- Número de teléfono: 1-877-240-9479
- Correo electrónico: information.center@astrazeneca.com
Ubicaciones de estudio
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Ancona, Italia, 60126
- Reclutamiento
- AOU Ospedali Riuniti di Ancona - Presidio Torrette
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Bari, Italia, 70124
- Retirado
- Azienda Ospedaliero-Universitaria Policlinico di Bari
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Brescia, Italia, 25123
- Reclutamiento
- ASST Spedali Civili di Brescia
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Florence, Italia, 50134
- Reclutamiento
- Azienda Ospedaliero-Universitaria Careggi
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Milan, Italia
- Aún no reclutando
- IRCCS Ospedale San Raffaele
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Milan, Italia, 20122
- Reclutamiento
- Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico
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Modena, Italia, 41124
- Aún no reclutando
- Policlinico di Modena - AOU di Modena
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Naples, Italia
- Aún no reclutando
- Azienda Ospedaliera Universitaria "Luigi Vanvitelli"
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Padova, Italia, 35128
- Aún no reclutando
- Azienda Ospedaliera di Padova
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Palermo, Italia, 90127
- Reclutamiento
- Azienda Ospedaliera Universitaria Policlinico "Paolo Giaccone"
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Pavia, Italia, 27100
- Reclutamiento
- Fondazione IRCCS Policlinico San Matteo
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Pisa, Italia, 56126
- Aún no reclutando
- Azienda Ospedaliero-Universitaria Pisana Ospedale Santa Chiara
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Roma, Italia, 00133
- Aún no reclutando
- Policlinico Tor Vergata
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Roma, Italia, 00161
- Reclutamiento
- Policlinico Umberto I - Sapienza Università di Roma
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Torino, Italia, 10128
- Aún no reclutando
- Azienda Ospedaliera Ordine Mauriziano Umberto I
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Trieste, Italia, 34128
- Reclutamiento
- Azienda Sanitaria Universitaria Giuliano Isontina (ASU GI) - Ospedale di Cattinara
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Udine, Italia, 33100
- Reclutamiento
- ASU Friuli Centrale - Ospedale Santa Maria della Misericordia di Udine
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Verona, Italia, 37134
- Reclutamiento
- AOUI Verona - Ospedale Borgo Roma
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CA
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Monserrato, CA, Italia, 09032
- Reclutamiento
- Azienda Ospedaliero-Universitaria di Cagliari Presidio di Monserrato
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Ferrara
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Cona, Ferrara, Italia, 44124
- Reclutamiento
- Azienda Ospedaliero-Universitaria di Ferrara Arcispedale Sant'Anna
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Foggia
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San Giovanni Rotondo, Foggia, Italia
- Reclutamiento
- IRCCS Casa Sollievo della Sofferenza
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Milano
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Rozzano, Milano, Italia, 20089
- Reclutamiento
- IRCCS Humanitas Research Hospital
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
- Niño
- Adulto
- Adulto Mayor
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Adult patients with Systemic Lupus Erythematous (SLE) according to 2019 EULAR/ACR classification criteria, treated with anifrolumab as per clinical practices.
Descripción
Inclusion Criteria:
- Provided informed consent to participate in the study;
- Aged 18 years or older;
- Fulfilled the 2019 EULAR/ACR classification criteria for SLE at the time of study entry;
- Prescribed anifrolumab for SLE treatment for the first time, according to the approved Italian label and reimbursement criteria;
Exclusion Criteria:
- Patients who are at LLDAS5 at the time of study entry;
- Previous exposure to anifrolumab;
- Documented diagnosis of severe or rapidly progressive Class III or IV glomerulonephritis requiring induction therapy [mycophenolate mofetil (MMF)/cyclophosphamide (CYC) + high dose steroids], isolated Class V lupus nephritis, or active severe or unstable neuropsychiatric lupus
- Currently participating in any interventional clinical trial with an investigational product;
- Inability to understand and sign the informed consent and to fill in patient questionnaires
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: PROSPECTIVE
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Number and percentage of patients achieving LLDAS5
Periodo de tiempo: 52 weeks
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proportion of patients with LLDAS5 at 52 weeks, defined as: LLDAS5 is defined as follows:
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52 weeks
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Number and percentage of patients reaching LLDAS5 at each time point
Periodo de tiempo: week 24, 76 and 104
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Proportion of patients with LLDAS5, according the following definition: LLDAS5 is defined as follows:
|
week 24, 76 and 104
|
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Number and percentage of patients achieving a GCS (Glucocorticosterioids) dose reduction
Periodo de tiempo: week 4, 12, 24, 52, 76, 104 vs baseline
|
Number and percentage of patients achieving a GCS dose reduction (to ≤ 5 mg/day; to 0 mg/day) at different timepoints (T1, T2, T3, T4, T5, T6) compared to T0 |
week 4, 12, 24, 52, 76, 104 vs baseline
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Median (range) cumulative dose of GCS
Periodo de tiempo: from week 0 to week 24; from week 24 to week 52; from week 52 to week 76; from week 76 to week 104
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Median cumulative dose of GCS calculated at each 6 month period following T0 |
from week 0 to week 24; from week 24 to week 52; from week 52 to week 76; from week 76 to week 104
|
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Mean(SD) change in tender and swollen joint count
Periodo de tiempo: week 4, 12, 24, 52, 76 and 104 vs week 0
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Mean change in tender and swollen joint count using Disease Activity Score 28 (DAS28) map at different timepoints compared to baseline (w0). DAS28 ranges from 0 (no-activity) to 10 (high disease activity) |
week 4, 12, 24, 52, 76 and 104 vs week 0
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mean (SD) change in Power Doppler (PD) Signal Total score
Periodo de tiempo: week 4, 12, 24, 52, 76 and 104 vs week 0
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Mean change in Power Doppler (PD) Signal at each time point vs baseline. PD Signal ranges from 0 (low) to 84 (high) |
week 4, 12, 24, 52, 76 and 104 vs week 0
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mean (SD) change in Synovial Hypertrophy (SH) Total score
Periodo de tiempo: week 4, 12, 24, 52, 76 and 104 vs week 0
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Mean change in synovial hypertrophy at each time point vs baseline. Synovial hypertrophy ranges from 0 (low) to 84 (high). |
week 4, 12, 24, 52, 76 and 104 vs week 0
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Annualize flaire rate
Periodo de tiempo: week 52 and week 104
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Annualized flare rate in the first and second years |
week 52 and week 104
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Number and percentage of patients meeting the DORIS clinical remission
Periodo de tiempo: week 12, 24, 52, 76 and 104
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Number and percentage of patients meeting the DORIS clinical remission definition at each timepoints, according to:
|
week 12, 24, 52, 76 and 104
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Number and percentage of patients with sustained DORIS remission
Periodo de tiempo: week 104
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Number and percentage of patients with sustained DORIS remission, defined as remaining in remission at or greater than 12 weeks after having met the DORIS definition |
week 104
|
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Mean (SD) HDRS (Hamilton Depression Rating Scale) total score
Periodo de tiempo: week 12, 24, 52 and 104 vs week 0
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Change in HDRS total score at different timepoints compared to T0. HDRS ranges from 0 (no depression) to 54 (severe) |
week 12, 24, 52 and 104 vs week 0
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Mean (SD) PROMIS Depression Short Form 8b (Patient-Reported Outcomes Measurement Information System) total score
Periodo de tiempo: week 12, 24, 52 and 104 vs week 0
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Change in PROMIS Depression Short Form 8b total score at different timepoints compared to week 0 (baseline). PROMIS raw scores ranges from 8 (no depression) to 40 (severe) |
week 12, 24, 52 and 104 vs week 0
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- D3461R00093
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