Evaluación de la satisfacción con el tratamiento a corto plazo y la calidad de vida en pacientes con hidradenitis supurativa iniciados con secukinumab.
Evaluación de la satisfacción con el tratamiento a corto plazo y la calidad de vida en pacientes con hidradenitis supurativa iniciados con secukinumab en la práctica clínica habitual en los Emiratos Árabes Unidos: ILLUMINATE-HS, una encuesta prospectiva de pacientes
This study will be conducted to address the lack of concrete data on the impact of pharmaceutical intervention on short-term patient satisfaction and quality of life (QoL) in patients with Hidradenitis Suppurativa (HS) in real-world settings, especially in the Gulf Region.
Descripción general del estudio
Descripción detallada
This is a 24-week longitudinal single-arm prospective study based on data collected from EMRs along with patient-reported outcomes questionnaires (TSQM and DLQI) to evaluate patient-reported satisfaction and early quality of life experiences among HS patients who are newly initiated on Secukinumab. We will be using questionnaires at baseline and at week 24 to report on pre-defined outcomes in a representative HS population across the United Arab Emirates. The data will be collected using an electronic Case Report Form (eCRF) from both data sources (Electronic Medical Report and Questionnaires).
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Abu Dhabi, Emiratos Árabes Unidos
- Novartis Investigative Site
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Al Ain Abu Dhabi, Emiratos Árabes Unidos
- Novartis Investigative Site
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Ras al-Khaimah, Emiratos Árabes Unidos
- Novartis Investigative Site
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Sharjah city, Emiratos Árabes Unidos
- Novartis Investigative Site
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.
Descripción
Inclusion Criteria:
- Patient with a confirmed diagnosis of active moderate to severe HS (Hurley Score 2-3)
- Male or Female adult patients ≥ 18 years of age at the time of data collection
- Patient newly initiated on Secukinumab (first dose to coincide within 1 month of the signature of the informed consent)
- Patients with a diagnosis of HS who are currently using antibiotics/ have undergone surgery or not as part of their routine clinical management are eligible for inclusion.
- Patients with a diagnosis of HS who have a history of previous treatment with Adalimumab or any other anti-TNF agent as part of their routine clinical management or biologic naïve are eligible for inclusion.
- Agreed to sign an informed consent to be able to fill in the questionnaires.
Exclusion Criteria:
- Patients not fulfilling any of the abovementioned inclusion criteria.
- Patient's refusal to be included in the study or refusal to sign the informed consent.
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: OTHER
- Perspectivas temporales: PROSPECTIVE
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Secukinumab
Patients who are newly initiated on treatment with Secukinumab |
This is an observational study. There is no treatment allocation. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
Periodo de tiempo: At Week 24
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TSQM scoring is calculated by domain, and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher patient satisfaction. 4 Domains: Effectiveness Side Effects Convenience Global Satisfaction |
At Week 24
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire
Periodo de tiempo: Baseline, Week 24
|
DLQI is a questionnaire designed to measure the impact of skin conditions on a patient's health-related quality of life. It contains 10 simple, self-administered questions. Focuses on the past week's experiences related to the skin condition. Each question uses a 4-point Likert scale: "Not at all," "A little," "A lot," "Very much." |
Baseline, Week 24
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Change from baseline in the Numerical Rating Scale (NRS)
Periodo de tiempo: Baseline, Week 24
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The NRS is commonly used for measuring pain intensity and is well validated. It is scored from 0-10 (0 meaning no pain and 10 meaning the worst pain imaginable). |
Baseline, Week 24
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Age (years)
Periodo de tiempo: Baseline
|
Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab |
Baseline
|
|
Gender (male/female)
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Ethnicity
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Weight (kilogram)
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Height (meters)
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
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Socio-economic status
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Smoking status
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Duration of the disease (time since diagnosis)
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
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Previous HS-related treatment
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Hurley Stage
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
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Number of inflammatory nodules, number of abscesses, and fistulas
Periodo de tiempo: Baseline
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Characteristics of HS patients started on Secukinumab |
Baseline
|
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Previous HS-related surgeries
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
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Previous use of biologic treatment
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Previous and current use of antibiotics treatment
Periodo de tiempo: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
Colaboradores e Investigadores
Patrocinador
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
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
Términos MeSH relevantes adicionales
- Infecciones
- Enfermedades de la piel
- Infecciones bacterianas
- Infecciones bacterianas y micosis
- Enfermedades de las glándulas sudoríparas
- Enfermedades De La Piel Bacterianas
- Enfermedades De La Piel Infecciosas
- Supuración
- Hidradenitis
- Enfermedades de la piel y del tejido conectivo
- Hidradenitis supurativa
- secukinumab
Otros números de identificación del estudio
- CAIN457AAE02
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.
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