REIMAGINE: evaluación en el mundo real de mepolizumab en el asma grave que logra la remisión clínica del tratamiento, un estudio prospectivo (REIMAGINE)
Un estudio intervencionista prospectivo del mundo real para evaluar el efecto de mepolizumab en el logro de la remisión clínica en participantes con asma grave
This is a prospective, real-world, single arm, global, multi-centre study to evaluate the effect of timely treatment with mepolizumab (NUCALA) to achieve clinical remission in adult participants with severe asthma with an eosinophilic phenotype (SA-EP).
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- Fase 4
Contactos y Ubicaciones
Ubicaciones de estudio
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Bonn, Alemania, 53119
- GSK Investigational Site
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Hohenstein-Ernsttal, Alemania, 9337
- GSK Investigational Site
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Schleswig, Alemania, 53123
- GSK Investigational Site
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Hesse
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Darmstadt, Hesse, Alemania, 64283
- GSK Investigational Site
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Frankfurt am Main, Hesse, Alemania, 60389
- GSK Investigational Site
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North Rhine-Westphalia
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Aachen, North Rhine-Westphalia, Alemania, 52074
- GSK Investigational Site
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Kortrijk, Bélgica, 8500
- GSK Investigational Site
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Liège, Bélgica, 4000
- GSK Investigational Site
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Alberta
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Calgary, Alberta, Canadá, T3B0M3
- GSK Investigational Site
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Calgary, Alberta, Canadá
- GSK Investigational Site
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Manitoba
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Winnipeg, Manitoba, Canadá, R3L 1Z5
- GSK Investigational Site
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Ontario
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Toronto, Ontario, Canadá, M5G 1E2
- GSK Investigational Site
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Barcelona, España, 08025
- GSK Investigational Site
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Girona, España, 17005
- GSK Investigational Site
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Valencia, España, 46015
- GSK Investigational Site
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California
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La Jolla, California, Estados Unidos, 92037
- GSK Investigational Site
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Newport Beach, California, Estados Unidos, 92663
- GSK Investigational Site
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Colorado
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Aurora, Colorado, Estados Unidos, 71105
- GSK Investigational Site
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Colorado Springs, Colorado, Estados Unidos, 80923
- GSK Investigational Site
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Connecticut
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New Haven, Connecticut, Estados Unidos, 06510
- GSK Investigational Site
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Florida
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Homestead, Florida, Estados Unidos, 33032-8185
- GSK Investigational Site
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Jacksonville, Florida, Estados Unidos, 32209
- GSK Investigational Site
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Miami, Florida, Estados Unidos, 33125
- GSK Investigational Site
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Plantation, Florida, Estados Unidos, 33317
- GSK Investigational Site
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Georgia
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Adairsville, Georgia, Estados Unidos, 30103
- GSK Investigational Site
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Columbus, Georgia, Estados Unidos, 31904
- GSK Investigational Site
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40509-1801
- GSK Investigational Site
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Owensboro, Kentucky, Estados Unidos, 42301
- GSK Investigational Site
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Louisiana
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New Orleans, Louisiana, Estados Unidos, 34452
- GSK Investigational Site
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Maryland
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Glenn Dale, Maryland, Estados Unidos, 20769
- GSK Investigational Site
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Towson, Maryland, Estados Unidos, 21204
- GSK Investigational Site
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Michigan
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Ann Arbor, Michigan, Estados Unidos, 48103
- GSK Investigational Site
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Minnesota
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Linwood, Minnesota, Estados Unidos, 55092
- GSK Investigational Site
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Rochester, Minnesota, Estados Unidos, 55905-0001
- GSK Investigational Site
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Nevada
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Henderson, Nevada, Estados Unidos, 89052-5015
- GSK Investigational Site
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New York
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Rochester, New York, Estados Unidos, 14607
- GSK Investigational Site
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Schenectady, New York, Estados Unidos, 12308
- GSK Investigational Site
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Pennsylvania
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Philadelphia, Pennsylvania, Estados Unidos, 19140
- GSK Investigational Site
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Philadelphia, Pennsylvania, Estados Unidos, 19141
- GSK Investigational Site
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South Carolina
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Union, South Carolina, Estados Unidos, 29379-7409
- GSK Investigational Site
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Texas
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Cypress, Texas, Estados Unidos, 77429-1439
- GSK Investigational Site
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Kerrville, Texas, Estados Unidos, 78028
- GSK Investigational Site
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McKinney, Texas, Estados Unidos, 75069
- GSK Investigational Site
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Brest, Francia, 29200
- GSK Investigational Site
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Cannes, Francia, 06614
- GSK Investigational Site
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Lille, Francia, 59000
- GSK Investigational Site
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Lyon, Francia, 69004
- GSK Investigational Site
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Strasbourg, Francia, 67091
- GSK Investigational Site
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Toulouse, Francia, 31059
- GSK Investigational Site
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Genova, Italia, 16132
- GSK Investigational Site
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Monserrato CA, Italia, 09042
- GSK Investigational Site
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Naples, Italia, 80131
- GSK Investigational Site
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Pieve Di Soligo TV, Italia, 131044
- GSK Investigational Site
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Roma, Italia, 00128
- GSK Investigational Site
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Roma, Italia, 161
- GSK Investigational Site
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Rozzano, Italia, 20089
- GSK Investigational Site
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Verona, Italia, 37126
- GSK Investigational Site
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Gifu, Japón, 509-6134
- GSK Investigational Site
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Kagawa, Japón, 760-0018
- GSK Investigational Site
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Tokyo, Japón, 142-8666
- GSK Investigational Site
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Tokyo, Japón, 173-8606
- GSK Investigational Site
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Tokyo, Japón, 105-0003
- GSK Investigational Site
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?Od?, Polonia, 90-153
- GSK Investigational Site
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Gdansk, Polonia, 80-214
- GSK Investigational Site
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Lodz, Polonia, 92-213
- GSK Investigational Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Participant has a confirmed asthma diagnosis and has been prescribed NUCALA by their physician for the treatment of asthma, as per local label. NUCALA can be initiated up to 7 days prior to study enrollment.
- No NUCALA use in the 6 months prior to enrollment.
- Participants with greater than or equal to (≥)60 percentage (%) predicted forced expiratory volume in 1 second (FEV1) and less than or equal to (≤)4 exacerbations per year, as confirmed by the physician.
- Other local prescription criteria of NUCALA not described above at NUCALA initiation (e.g., local reimbursement criteria).
- Written informed consent
Exclusion Criteria:
- Investigator concerns about participant's willingness to adhere to biologic treatment for any reason (e.g., cost, behavior, difficulty with access to healthcare)
- Participants currently on maintenance OCS or intramuscular corticosteroids.
- Participants using omalizumab, reslizumab, dupilumab, tezepelumab, or benralizumab within the 6 months prior to enrollment
- Participants participating in an interventional study with a treatment intervention
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Otro
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Otro: Group 1
Participants with a clinical diagnosis of Severe asthma prescribed Mepolizumab as part of routine care. |
Mepolizumab will be prescribed based on physician decision. Lung function via spirometry will be collected. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Percentage (%) of Participants Achieving 4-Component Clinical Remission
Periodo de tiempo: At month 12
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4-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an Asthma Control Test (ACT) (d) No clinically significant deterioration of lung function. |
At month 12
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Annualized Rates of Clinically Significant Asthma Exacerbations (CSE) and CSE Leading to Hospitalization/ Emergency Room (ER) Visits
Periodo de tiempo: At month 12
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CSE is defined as a deterioration in asthma requiring (1) the initiation of systemic corticosteroids and/or (2) an ER visit and/or hospital admission. |
At month 12
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Percentage of Participants Achieving OCS Sparing Remission
Periodo de tiempo: At month 12
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OCS sparing is defined as (a) No clinically significant asthma exacerbations during the period of interest (b) No OCS use for asthma at the time point of interest. |
At month 12
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Percentage of Participants Achieving 3-Component Clinical Remission
Periodo de tiempo: At month 12
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3-component clinical remission is defined as (a) No clinically significant asthma exacerbations (b) No OCS use for asthma (c) Well controlled asthma based on an ACT |
At month 12
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Mean Change from Baseline in Mini-Asthma Quality of Life Questionnaire (AQLQ) Overall Score
Periodo de tiempo: Baseline and at month 12
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The mini-AQLQ overall score is a reduced version of the AQLQ which includes 15 items. The minimally clinically important difference (MCID) is 0.5. The response options for each item are on an equidistant scale of 7 points, where 1 corresponds to the maximum disability and 7 to the absence of disability |
Baseline and at month 12
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: GSK Clinical Trials, GlaxoSmithKline
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
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
- 219871
- 2023 (Subvención/contrato del NIH de EE. UU.)
- 2023-509026-21-00 (Identificador de registro: CTIS (EU))
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Descripción del plan IPD
Qualified researchers may request access to anonymized individual patient-level data (IPD) and related study documents of the eligible studies via the Data Sharing Portal. Details on GSK's data sharing criteria can be found at: https://www.gsk.com/en-gb/innovation/trials/data-transparency/
Marco de tiempo para compartir IPD
Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
Criterios de acceso compartido de IPD
Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.
Tipo de información de apoyo para compartir IPD
- PROTOCOLO DE ESTUDIO
- SAVIA
- CIF
- RSC
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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. .