Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab.

Recruiting

• Conditions: Hidradenitis Suppurativa

• Registration Number: NCT06785675
• Lead Sponsor: Novartis Pharmaceuticals

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).

Study Timeline

• Study First Submitted: 2024-11-27
• Study First Submitted QC: 2025-01-14
• Status Verified: 2025-03
• Study Start: 2025-03-10
• Study First Posted: 2025-03-25
• Last Update Submitted: 2025-03-26
• Last Update Posted: 2025-04-01
• Primary Completion: 2025-11-29
• Study Completion: 2025-11-29

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire	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

Secondary Outcome Measures

Name	Time	Method
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire	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."
Change from baseline in the Numerical Rating Scale (NRS)	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).
Age (years)	Baseline	Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab
Gender (male/female)	Baseline	Characteristics of HS patients started on Secukinumab
Ethnicity	Baseline	Characteristics of HS patients started on Secukinumab
Weight (kilogram)	Baseline	Characteristics of HS patients started on Secukinumab
Height (meters)	Baseline	Characteristics of HS patients started on Secukinumab
Socio-economic status	Baseline	Characteristics of HS patients started on Secukinumab
Smoking status	Baseline	Characteristics of HS patients started on Secukinumab
Duration of the disease (time since diagnosis)	Baseline	Characteristics of HS patients started on Secukinumab
Previous HS-related treatment	Baseline	Characteristics of HS patients started on Secukinumab
Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab	Baseline	Characteristics of HS patients started on Secukinumab
Hurley Stage	Baseline	Characteristics of HS patients started on Secukinumab
Number of inflammatory nodules, number of abscesses, and fistulas	Baseline	Characteristics of HS patients started on Secukinumab
Previous HS-related surgeries	Baseline	Characteristics of HS patients started on Secukinumab
Previous use of biologic treatment	Baseline	Characteristics of HS patients started on Secukinumab
Previous and current use of antibiotics treatment	Baseline	Characteristics of HS patients started on Secukinumab

Trial Locations

Locations (1)

Novartis Investigative Site; 🇦🇪 Sharjah, United Arab Emirates