Secukinmab
OtherThis is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement.
Other names: Cosentyx
NCT Number: NCT06785779
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.
Interested in participating?
Request Info18 year–99 year
All sexes
Observational
Novartis Investigative Site, Riyadh, SAU, Saudi Arabia
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):
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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
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.
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.
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)
Time frame: Baseline
Age at baseline (years)
Time frame: Baseline
Assessment of Participant's ethnicity
Time frame: Baseline
Assessment of socio-economic status
Time frame: Baseline
Assessment of smoking status
Time frame: Baseline
Number of participants with family history of HS
Time frame: Baseline
Time since- symptom onset and/or diagnosis
Time frame: Baseline
Number of participants with Previous HS- related treatment including treatment type
Time frame: Baseline
Number of participants with Previous HS- related surgeries including surgery type
Time frame: Baseline
Number of participants with current or previous use of antibiotic treatment including antibiotic type.
Time frame: Baseline
Time from diagnosis to start the first treatment and Time from diagnosis to start of Secukinumab
Time frame: Baseline
Assessment of concomitant medications
Time frame: Baseline
Classification of HS severity assessed by Hurley staging scale, Stage I (Mild) , Stage II (Moderate) and stage III (Severe)
Time frame: Baseline
Number of inflammatory nodules, abscesses and draining tunnels/fistula
Contact information is provided by the study sponsor or research team.
Novartis Pharmaceuticals
Industry
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
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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