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

NCT ID: NCT06785675

Last Updated: 2025-10-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

60 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-10

Study Completion Date

2025-11-29

Brief Summary

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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

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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).

Conditions

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Hidradenitis Suppurativa

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Secukinumab

Patients who are newly initiated on treatment with Secukinumab

Secukinumab

Intervention Type OTHER

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

Interventions

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Secukinumab

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

Intervention Type OTHER

Eligibility Criteria

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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.

* Patient's refusal to be included in the study or refusal to sign the informed consent.
Minimum Eligible Age

18 Years

Maximum Eligible Age

99 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Novartis Investigative Site

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

Site Status RECRUITING

Novartis Investigative Site

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Novartis Investigative Site

Ras al-Khaimah, , United Arab Emirates

Site Status RECRUITING

Novartis Investigative Site

Sharjah city, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

+41613241111

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CAIN457AAE02

Identifier Type: -

Identifier Source: org_study_id

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