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

Novartis

Status: Enrolling

Conditions: Hidradenitis Suppurativa (HS)

Treatments: Other: Secukinmab

Study type: Observational

Funder types: Industry

Identifiers

NCT06785779

CAIN457MSA01

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 77 estimated patients

Sex: All

Ages: 18 to 99 years old

Volunteers: No Healthy Volunteers

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.

Exclusion criteria

1. Patients not fulfilling any of the above-mentioned inclusion criteria.
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.

Trial design

77 participants in 1 patient group

Secukinumab

Description:

Patients who are newly initiated on Secukinumab

Treatment:

Other: Secukinmab