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

N/AActive Not RecruitingNCT06785675

Novartis Pharmaceuticals48 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

Conditions

Hidradenitis Suppurativa

Interventions

SecukinumabOTHER

This is an observational study. There is no treatment allocation.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (4)

Novartis Investigative Site

Al Ain Abu Dhabi, United Arab Emirates, United Arab Emirates

Novartis Investigative Site

Abu Dhabi, United Arab Emirates

Novartis Investigative Site

Ras al-Khaimah, United Arab Emirates

Novartis Investigative Site

Sharjah city, United Arab Emirates

Outcomes

Primary Outcomes

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

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

Time frame: At Week 24

Secondary Outcomes

Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire

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."

Time frame: Baseline, Week 24

Change from baseline in the Numerical Rating Scale (NRS)

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).

Time frame: Baseline, Week 24

Age (years)

Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab

Time frame: Baseline

Gender (male/female)

Characteristics of HS patients started on Secukinumab

Time frame: Baseline

Ethnicity

Characteristics of HS patients started on Secukinumab

Time frame: Baseline

Data from ClinicalTrials.gov

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