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NCT Number: NCT06785779

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

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.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Riyadh, SAU, Saudi Arabia

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Secukinmab

Other

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

Other names: Cosentyx

Primary outcomes

  1. Mean Score in the Treatment Satisfaction Questionnaire (TSQM)

    Time frame: Week 24

    TSQM questionnaire consists of 14 questions with a score ranging from 0 to 100. The questionnaire has four subscales, effectiveness (3 questions), side Effects (5 questions), convenience (3 questions) and global Satisfaction (3 questions).

    TSQM scoring is calculated by each subscale, which ranges from 0 to 100, with higher scores indicating higher patient satisfaction with medication.

Secondary outcomes

  1. Mean change from baseline in patient-reported QoL via the Dermatology Life Quality Index (DLQI) Questionnaire

    Time frame: Baseline, week 24

    The DLQI is a valid 10-item instrument used to measure the impact of skin diseases on a patient's quality of life. Each question is scored on a scale of 0 to 3, with 0 indicating "not at all" and 3 indicating "very much." The total score ranges from 0 to 30, with a higher score indicating a greater impact on the patient's quality of life.

  2. Mean change from baseline to week 24 in the Numeric Pain Rating Scale (NPRS-11)

    Time frame: Baseline, week 24

    NPRS-11 is a subjective measure representing pain intensity in which individuals rate their pain on an eleven-point numerical scale. The scale is composed of 0 (no pain at all) to 10 (worst imaginable pain)

  3. Baseline characteristics-age

    Time frame: Baseline

    Age at baseline (years)

  4. Baseline characteristics - Ethnicity

    Time frame: Baseline

    Assessment of Participant's ethnicity

  5. Baseline characteristics - Socio-economic status

    Time frame: Baseline

    Assessment of socio-economic status

  6. Baseline characteristics - smoking status

    Time frame: Baseline

    Assessment of smoking status

  7. Baseline characteristics - Family history of HS

    Time frame: Baseline

    Number of participants with family history of HS

  8. Baseline characteristics - Duration of the disease

    Time frame: Baseline

    Time since- symptom onset and/or diagnosis

  9. Baseline characteristics - Previous HS-related treatment

    Time frame: Baseline

    Number of participants with Previous HS- related treatment including treatment type

  10. Baseline characteristics - previous HS-related surgeries

    Time frame: Baseline

    Number of participants with Previous HS- related surgeries including surgery type

  11. Baseline characteristics - Current or previous use of antibiotic treatment

    Time frame: Baseline

    Number of participants with current or previous use of antibiotic treatment including antibiotic type.

  12. Baseline characteristics - Time since diagnosis to first treatment and secukinumab treatment

    Time frame: Baseline

    Time from diagnosis to start the first treatment and Time from diagnosis to start of Secukinumab

  13. Baseline characteristics - concomitant medications

    Time frame: Baseline

    Assessment of concomitant medications

  14. Baseline characteristics - Hurley Stage

    Time frame: Baseline

    Classification of HS severity assessed by Hurley staging scale, Stage I (Mild) , Stage II (Moderate) and stage III (Severe)

  15. Baseline characteristics - number of inflammatory nodules, abscesses and draining tunnels/fistula

    Time frame: Baseline

    Number of inflammatory nodules, abscesses and draining tunnels/fistula

Study contacts

Contact information is provided by the study sponsor or research team.

Novartis Pharmaceuticals

CONTACT

[email protected]

+41613241111

Novartis Pharmaceuticals

CONTACT

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study 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

Acronym: ILLUMINATE-SA

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2025
Registry last updated
Dec 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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