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

Novartis Pharmaceuticals77 enrolled

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Hidradenitis Suppurativa (HS)

Interventions

SecukinmabOTHER

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

Eligibility

Sex: ALLMin age: 18 YearsMax age: 99 Years

Medical Language ↔ Plain English

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.

Locations (4)

Novartis Investigative Site

Riyadh, SAU, Saudi Arabia

RECRUITING

Novartis Investigative Site

Jeddah, Saudi Arabia

RECRUITING

Novartis Investigative Site

Jeddah, Saudi Arabia

RECRUITING

Outcomes

Primary Outcomes

Mean Score in the Treatment Satisfaction Questionnaire (TSQM)

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.

Time frame: Week 24

Secondary Outcomes

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

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.

Time frame: Baseline, week 24

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

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)

Time frame: Baseline, week 24

Baseline characteristics-age

Age at baseline (years)

Time frame: Baseline

Baseline characteristics - Ethnicity

Assessment of Participant's ethnicity

Time frame: Baseline

Baseline characteristics - Socio-economic status

Assessment of socio-economic status

Central Contacts

Novartis Pharmaceuticals

CONTACT

+41613241111 novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

Data from ClinicalTrials.gov

This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.