Évaluation de la satisfaction du traitement à court terme et de la qualité de vie des patients atteints d'hidradénite suppurée initiés sous sécukinumab.
Évaluation de la satisfaction du traitement à court terme et de la qualité de vie des patients atteints d'hidradénite suppurée initiés sous sécukinumab dans la pratique clinique de routine aux Émirats arabes unis : ILLUMINATE-HS, une enquête prospective auprès des patients
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.
Aperçu de l'étude
Description détaillée
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).
Type d'étude
Inscription (Réel)
Contacts et emplacements
Lieux d'étude
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Abu Dhabi, Emirats Arabes Unis
- Novartis Investigative Site
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Al Ain Abu Dhabi, Emirats Arabes Unis
- Novartis Investigative Site
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Ras al-Khaimah, Emirats Arabes Unis
- Novartis Investigative Site
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Sharjah city, Emirats Arabes Unis
- Novartis Investigative Site
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
Méthode d'échantillonnage
Population étudiée
Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.
La description
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 d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Modèles d'observation: OTHER
- Perspectives temporelles: PROSPECTIVE
Cohortes et interventions
Groupe / Cohorte |
Intervention / Traitement |
|---|---|
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Secukinumab
Patients who are newly initiated on treatment with Secukinumab |
This is an observational study. There is no treatment allocation. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
Délai: 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
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire
Délai: 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)
Délai: 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)
Délai: Baseline
|
Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab |
Baseline
|
|
Gender (male/female)
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Ethnicity
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Weight (kilogram)
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Height (meters)
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Socio-economic status
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Smoking status
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Duration of the disease (time since diagnosis)
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Previous HS-related treatment
Délai: 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
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
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Hurley Stage
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Number of inflammatory nodules, number of abscesses, and fistulas
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Previous HS-related surgeries
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous use of biologic treatment
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous and current use of antibiotics treatment
Délai: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
Collaborateurs et enquêteurs
Parrainer
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- CAIN457AAE02
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Étudie un produit d'appareil réglementé par la FDA américaine
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