Clinical trial NCT06785675: Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab.
Official title: Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab in Routine Clinical Practice in the United Arab Emirates: ILLUMINATE-HS, a Prospective Patient Surve
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Hidradenitis Suppurativa
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-01-21
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.

Brief summary: 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.

Detailed description: 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).

Eligibility criteria: 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.

Primary outcomes:
measure: The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
timeFrame: At Week 24
Secondary outcomes:
measure: Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire
timeFrame: Baseline, Week 24
measure: Change from baseline in the Numerical Rating Scale (NRS)
timeFrame: Baseline, Week 24
measure: Age (years)
timeFrame: Baseline
measure: Gender (male/female)
timeFrame: Baseline
measure: Ethnicity
timeFrame: Baseline
measure: Weight (kilogram)
timeFrame: Baseline
measure: Height (meters)
timeFrame: Baseline
measure: Socio-economic status
timeFrame: Baseline
measure: Smoking status
timeFrame: Baseline
measure: Duration of the disease (time since diagnosis)
timeFrame: Baseline
measure: Previous HS-related treatment
timeFrame: Baseline
measure: Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab
timeFrame: Baseline
measure: Hurley Stage
timeFrame: Baseline
measure: Number of inflammatory nodules, number of abscesses, and fistulas
timeFrame: Baseline
measure: Previous HS-related surgeries
timeFrame: Baseline
measure: Previous use of biologic treatment
timeFrame: Baseline
measure: Previous and current use of antibiotics treatment
timeFrame: Baseline
Other outcomes:
Locations:
city: Sharjah
country: United Arab Emirates
facility: Novartis Investigative Site
Study officials:
References: