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

Novartis

Status

Enrolling

Conditions

Hidradenitis Suppurativa

Treatments

Other: Secukinumab

Study type

Observational

Funder types

Industry

Identifiers

NCT06785675

CAIN457AAE02

Details and patient eligibility

About

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.

Full 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).

Enrollment

60 estimated patients

Sex

All

Ages

18 to 99 years old

Volunteers

No Healthy Volunteers

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.