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NCT Number: NCT06785675

Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab.

This study will be conducted to address the lack of concrete data on the impact of pharmaceutical intervention on short-term patient satisfaction and quality of life (QoL) in patients with Hidradenitis Suppurativa (HS) in real-world settings, especially in the Gulf Region.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

18 year–99 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Novartis Investigative Site, Al Ain Abu Dhabi, United Arab Emirates

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About this study

This is a 24-week longitudinal single-arm prospective study based on data collected from EMRs along with patient-reported outcomes questionnaires (TSQM and DLQI) to evaluate patient-reported satisfaction and early quality of life experiences among HS patients who are newly initiated on Secukinumab. We will be using questionnaires at baseline and at week 24 to report on pre-defined outcomes in a representative HS population across the United Arab Emirates. The data will be collected using an electronic Case Report Form (eCRF) from both data sources (Electronic Medical Report and Questionnaires).

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patient with a confirmed diagnosis of active moderate to severe HS (Hurley Score 2-3)
  • Male or Female adult patients ≥ 18 years of age at the time of data collection
  • Patient newly initiated on Secukinumab (first dose to coincide within 1 month of the signature of the informed consent)
  • Patients with a diagnosis of HS who are currently using antibiotics/ have undergone surgery or not as part of their routine clinical management are eligible for inclusion.
  • Patients with a diagnosis of HS who have a history of previous treatment with Adalimumab or any other anti-TNF agent as part of their routine clinical management or biologic naïve are eligible for inclusion.
  • Agreed to sign an informed consent to be able to fill in the questionnaires.

Exclusion criteria

  • Patients not fulfilling any of the abovementioned inclusion criteria.
  • Patient's refusal to be included in the study or refusal to sign the informed consent.

Treatment and study plan

secukinumab

Other

This is an observational study. There is no treatment allocation.

Primary outcomes

  1. The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire

    Time frame: At Week 24

    TSQM scoring is calculated by domain, and each domain score is computed by summing the individual TSQM items in each domain and then transforming the composite score into a value ranging from 0 to 100, with higher scores indicating higher patient satisfaction.

    4 Domains:

    Effectiveness Side Effects Convenience Global Satisfaction

Secondary outcomes

  1. Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire

    Time frame: Baseline, Week 24

    DLQI is a questionnaire designed to measure the impact of skin conditions on a patient's health-related quality of life. It contains 10 simple, self-administered questions. Focuses on the past week's experiences related to the skin condition. Each question uses a 4-point Likert scale: "Not at all," "A little," "A lot," "Very much."

  2. Change from baseline in the Numerical Rating Scale (NRS)

    Time frame: Baseline, Week 24

    The NRS is commonly used for measuring pain intensity and is well validated. It is scored from 0-10 (0 meaning no pain and 10 meaning the worst pain imaginable).

  3. Age (years)

    Time frame: Baseline

    Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab

  4. Gender (male/female)

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  5. Ethnicity

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  6. Weight (kilogram)

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  7. Height (meters)

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  8. Socio-economic status

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  9. Smoking status

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  10. Duration of the disease (time since diagnosis)

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  11. Previous HS-related treatment

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  12. Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  13. Hurley Stage

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  14. Number of inflammatory nodules, number of abscesses, and fistulas

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  15. Previous HS-related surgeries

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  16. Previous use of biologic treatment

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

  17. Previous and current use of antibiotics treatment

    Time frame: Baseline

    Characteristics of HS patients started on Secukinumab

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab in Routine Clinical Practice in the United Arab Emirates: ILLUMINATE-HS, a Prospective Patient Surve

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Jan 21, 2025
Registry last updated
Jun 16, 2026

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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