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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Patients who are newly initiated on treatment with Secukinumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinumab | Other | This is an observational study. There is no treatment allocation. |
|
| Measure | Description | Time Frame |
|---|---|---|
| The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire | 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 | At Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire | 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." |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Al Ain Abu Dhabi | United Arab Emirates | United Arab Emirates | |||
| Novartis Investigative Site |
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| Baseline, Week 24 |
| Change from baseline in the Numerical Rating Scale (NRS) | 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). | Baseline, Week 24 |
| Age (years) | Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab | Baseline |
| Gender (male/female) | Characteristics of HS patients started on Secukinumab | Baseline |
| Ethnicity | Characteristics of HS patients started on Secukinumab | Baseline |
| Weight (kilogram) | Characteristics of HS patients started on Secukinumab | Baseline |
| Height (meters) | Characteristics of HS patients started on Secukinumab | Baseline |
| Socio-economic status | Characteristics of HS patients started on Secukinumab | Baseline |
| Smoking status | Characteristics of HS patients started on Secukinumab | Baseline |
| Duration of the disease (time since diagnosis) | Characteristics of HS patients started on Secukinumab | Baseline |
| Previous HS-related treatment | Characteristics of HS patients started on Secukinumab | Baseline |
| Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab | Characteristics of HS patients started on Secukinumab | Baseline |
| Hurley Stage | Characteristics of HS patients started on Secukinumab | Baseline |
| Number of inflammatory nodules, number of abscesses, and fistulas | Characteristics of HS patients started on Secukinumab | Baseline |
| Previous HS-related surgeries | Characteristics of HS patients started on Secukinumab | Baseline |
| Previous use of biologic treatment | Characteristics of HS patients started on Secukinumab | Baseline |
| Previous and current use of antibiotics treatment | Characteristics of HS patients started on Secukinumab | Baseline |
| Abu Dhabi |
| United Arab Emirates |
| Novartis Investigative Site | Ras al-Khaimah | United Arab Emirates |
| Novartis Investigative Site | Sharjah city | United Arab Emirates |
| ID | Term |
|---|---|
| D017497 | Hidradenitis Suppurativa |
| ID | Term |
|---|---|
| D017192 | Skin Diseases, Bacterial |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D013492 | Suppuration |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D016575 | Hidradenitis |
| D013543 | Sweat Gland Diseases |
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| ID | Term |
|---|---|
| C555450 | secukinumab |
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