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Short-term Treatment Satisfaction in Hidradenitis Suppurativa Patients Initiated on Cosentyx in Routine Clinical Practice in Saudi Arabia

NCT ID: NCT06785779

Last Updated: 2025-12-30

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

77 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-03-10

Study Completion Date

2026-09-30

Brief Summary

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This study aims to assess the treatment satisfaction of HS patients newly started on secukinumab in Saudi Arabia, in terms of patient reported convenience, perceived safety, perceived effectiveness and global treatment satisfaction as measured by the treatment satisfaction questionnaire for medication (TSQM) at week 24 among moderate to severe HS patients.

Detailed Description

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This is a 24-week longitudinal single arm prospective study based on data collected from electronic medical records (EMRs) and patient-reported outcomes questionnaires (TSQM, DLQI, and NPRS-11) to evaluate patient-reported satisfaction and early QoL experiences among HS adult patients who are newly administering Secukinumab as per routine clinical practice.

Data will be captured from both data sources (EMRs and Questionnaires) at the following time points (+/- 1 month):

* Baseline (index date: initiation of Secukinumab),
* 24 weeks.

This is in line with the frequency of routine follow-up visits and as per the standard of care to report on pre-defined outcomes in a representative HS population across Saudi Arabia.

Conditions

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Hidradenitis Suppurativa (HS)

Keywords

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Hidradenitis Suppurativa HS secukinumab NIS Saudi Arabia

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Secukinumab

Patients who are newly initiated on Secukinumab

Secukinmab

Intervention Type OTHER

This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.

Interventions

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Secukinmab

This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.

Intervention Type OTHER

Other Intervention Names

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Cosentyx

Eligibility Criteria

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Inclusion Criteria

1. Male or Female adult patients ≥18 years of age at the time of data collection.
2. Patient with a confirmed diagnosis of active moderate to severe HS.
3. Secukinumab naive patients (first dose to coincide within one month of the signature of the informed consent) as per locally approved label.
4. Patients can be using antibiotics or have undergone surgery as per routine clinical practice.
5. Patients agree to sign an informed consent form (ICF) to be able to complete the questionnaires.

2. Patient's refusal to be included in the study or refusal to sign the ICF.
3. A history of off-label indication uses of biological treatment or JAK inhibitor.
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

Riyadh, SAU, Saudi Arabia

Site Status RECRUITING

Novartis Investigative Site

Jeddah, , Saudi Arabia

Site Status RECRUITING

Novartis Investigative Site

Jeddah, , Saudi Arabia

Site Status RECRUITING

Novartis Investigative Site

Riyadh, , Saudi Arabia

Site Status RECRUITING

Countries

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Saudi Arabia

Central Contacts

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Novartis Pharmaceuticals

Role: CONTACT

Phone: +41613241111

Email: [email protected]

Novartis Pharmaceuticals

Role: CONTACT

Other Identifiers

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CAIN457MSA01

Identifier Type: -

Identifier Source: org_study_id