About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial 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
Trial design
Cohort
Prospective
Treatments tested in this trial
Secukinmab
Other interventionThis is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.
Treatment groups
Trial 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.
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.
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)
Baseline characteristics-age
Age at baseline (years)
Baseline characteristics - Ethnicity
Assessment of Participant's ethnicity
Sponsors and contacts
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