Vurdere kortsiktig behandlingstilfredshet og livskvalitet hos pasienter med Hidradenitis Suppurativa initiert på Secukinumab.
Vurdering av kortsiktig behandlingstilfredshet og livskvalitet hos pasienter med Hidradenitis Suppurativa initiert på Secukinumab i rutinemessig klinisk praksis i De forente arabiske emirater: ILLUMINATE-HS, en potensiell pasientundersøkelse
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.
Studieoversikt
Detaljert beskrivelse
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
Registrering (Faktiske)
Kontakter og plasseringer
Studiesteder
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Abu Dhabi, De forente arabiske emirater
- Novartis Investigative Site
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Al Ain Abu Dhabi, De forente arabiske emirater
- Novartis Investigative Site
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Ras al-Khaimah, De forente arabiske emirater
- Novartis Investigative Site
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Sharjah city, De forente arabiske emirater
- Novartis Investigative Site
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.
Beskrivelse
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.
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: OTHER
- Tidsperspektiver: PROSPECTIVE
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
Secukinumab
Patients who are newly initiated on treatment with Secukinumab |
This is an observational study. There is no treatment allocation. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: Baseline
|
Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab |
Baseline
|
|
Gender (male/female)
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Ethnicity
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Weight (kilogram)
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Height (meters)
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Socio-economic status
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Smoking status
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Duration of the disease (time since diagnosis)
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous HS-related treatment
Tidsramme: 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
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Hurley Stage
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Number of inflammatory nodules, number of abscesses, and fistulas
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Previous HS-related surgeries
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Previous use of biologic treatment
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
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Previous and current use of antibiotics treatment
Tidsramme: Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Faktiske)
Studiet fullført (Faktiske)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- CAIN457AAE02
Legemiddel- og utstyrsinformasjon, studiedokumenter
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