Short-term Treatment Satisfaction in Hidradenitis Suppurativa Patients Initiated on Cosentyx in Routine Clinical Practice in Saudi Arabia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Secukinmab.
- Who it may be relevant to
- Registry conditions: Hidradenitis Suppurativa (HS). Basic parameters: 18 years — 99 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Saudi Arabia
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Other Secukinmab
This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.
Primary outcome measures
- Mean Score in the Treatment Satisfaction Questionnaire (TSQM) [Time frame: Week 24]
Secondary outcome measures (12)
- Mean change from baseline in patient-reported QoL via the Dermatology Life Quality Index (DLQI) Questionnaire [Time frame: Baseline, week 24]
- Mean change from baseline to week 24 in the Numeric Pain Rating Scale (NPRS-11) [Time frame: Baseline, week 24]
- Baseline characteristics-age [Time frame: Baseline]
- Baseline characteristics - Ethnicity [Time frame: Baseline]
- Baseline characteristics - Socio-economic status [Time frame: Baseline]
- Baseline characteristics - smoking status [Time frame: Baseline]
- Baseline characteristics - Family history of HS [Time frame: Baseline]
- Baseline characteristics - Duration of the disease [Time frame: Baseline]
- Baseline characteristics - Previous HS-related treatment [Time frame: Baseline]
- Baseline characteristics - previous HS-related surgeries [Time frame: Baseline]
- Baseline characteristics - Current or previous use of antibiotic treatment [Time frame: Baseline]
- Baseline characteristics - Time since diagnosis to first treatment and secukinumab treatment [Time frame: Baseline]
Eligibility criteria
Inclusion criteria
- Male or Female adult patients ≥18 years of age at the time of data collection.
- Patient with a confirmed diagnosis of active moderate to severe HS.
- Secukinumab naive patients (first dose to coincide within one month of the signature of the informed consent) as per locally approved label.
- Patients can be using antibiotics or have undergone surgery as per routine clinical practice.
- Patients agree to sign an informed consent form (ICF) to be able to complete the questionnaires.
Exclusion criteria
- Patients not fulfilling any of the above-mentioned inclusion criteria.
- Patient's refusal to be included in the study or refusal to sign the ICF.
- A history of off-label indication uses of biological treatment or JAK inhibitor.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Saudi Arabia · 4 centers
- Novartis Investigative Site — Riyadh
- Novartis Investigative Site — Jeddah
- Novartis Investigative Site — Jeddah
- Novartis Investigative Site — Riyadh
Identifiers
NCT: NCT06785779 · CAIN457MSA01