Clinical trial NCT06785779: Short-term Treatment Satisfaction in Hidradenitis Suppurativa Patients Initiated on Cosentyx in Routine Clinical Practice in Saudi Arabia
Official title: Survey Assessing Prospective Patient's Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Cosentyx (Secukinumab) in Routine Clinical Practice in Saudi Arabia: ILLUMINATE-SA
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Hidradenitis Suppurativa (HS)
Keywords: Hidradenitis Suppurativa
HS
secukinumab
NIS
Saudi Arabia
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2025-01-21
Enrollment: 77
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients who are newly initiated on Secukinumab as per locally approved labels and routine clinical practice will be enrolled over a period of 6 months and followed up for 24 weeks to assess study outcomes

Brief summary: 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: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Mean Score in the Treatment Satisfaction Questionnaire (TSQM)
timeFrame: Week 24
Secondary outcomes:
measure: Mean change from baseline in patient-reported QoL via the Dermatology Life Quality Index (DLQI) Questionnaire
timeFrame: Baseline, week 24
measure: Mean change from baseline to week 24 in the Numeric Pain Rating Scale (NPRS-11)
timeFrame: Baseline, week 24
measure: Baseline characteristics-age
timeFrame: Baseline
measure: Baseline characteristics - Ethnicity
timeFrame: Baseline
measure: Baseline characteristics - Socio-economic status
timeFrame: Baseline
measure: Baseline characteristics - smoking status
timeFrame: Baseline
measure: Baseline characteristics - Family history of HS
timeFrame: Baseline
measure: Baseline characteristics - Duration of the disease
timeFrame: Baseline
measure: Baseline characteristics - Previous HS-related treatment
timeFrame: Baseline
measure: Baseline characteristics - previous HS-related surgeries
timeFrame: Baseline
measure: Baseline characteristics - Current or previous use of antibiotic treatment
timeFrame: Baseline
measure: Baseline characteristics - Time since diagnosis to first treatment and secukinumab treatment
timeFrame: Baseline
measure: Baseline characteristics - concomitant medications
timeFrame: Baseline
measure: Baseline characteristics - Hurley Stage
timeFrame: Baseline
measure: Baseline characteristics - number of inflammatory nodules, abscesses and draining tunnels/fistula
timeFrame: Baseline
Other outcomes:
Locations:
Study officials:
References: