Beoordeling van de tevredenheid over de behandeling op korte termijn en de kwaliteit van leven bij patiënten met Hidradenitis Suppurativa die zijn gestart met Secukinumab.
Beoordeling van de tevredenheid over de behandeling op korte termijn en de kwaliteit van leven bij patiënten met Hidradenitis Suppurativa gestart met Secukinumab in de routinematige klinische praktijk in de Verenigde Arabische Emiraten: ILLUMINATE-HS, een prospectieve patiëntensurvey
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.
Studie Overzicht
Gedetailleerde beschrijving
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).
Studietype
Inschrijving (Werkelijk)
Contacten en locaties
Studie Locaties
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Abu Dhabi, Verenigde Arabische Emiraten
- Novartis Investigative Site
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Al Ain Abu Dhabi, Verenigde Arabische Emiraten
- Novartis Investigative Site
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Ras al-Khaimah, Verenigde Arabische Emiraten
- Novartis Investigative Site
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Sharjah city, Verenigde Arabische Emiraten
- Novartis Investigative Site
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Bemonsteringsmethode
Studie Bevolking
Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: OTHER
- Tijdsperspectieven: PROSPECTIVE
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
|---|---|
|
Secukinumab
Patients who are newly initiated on treatment with Secukinumab |
This is an observational study. There is no treatment allocation. |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
Tijdsspanne: At Week 24
|
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
|
Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
|
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire
Tijdsspanne: 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)
Tijdsspanne: Baseline, Week 24
|
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
|
|
Age (years)
Tijdsspanne: Baseline
|
Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab |
Baseline
|
|
Gender (male/female)
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Ethnicity
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Weight (kilogram)
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Height (meters)
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Socio-economic status
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Smoking status
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Duration of the disease (time since diagnosis)
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous HS-related treatment
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Hurley Stage
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Number of inflammatory nodules, number of abscesses, and fistulas
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous HS-related surgeries
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous use of biologic treatment
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous and current use of antibiotics treatment
Tijdsspanne: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
Medewerkers en onderzoekers
Sponsor
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- CAIN457AAE02
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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