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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):
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Secukinumab | Patients who are newly initiated on Secukinumab |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Secukinmab | Other | This is an observational study. There is no treatment allocation. The decision to initiate secukinumab will be based solely on clinical judgement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Novartis Pharmaceuticals | Contact | +41613241111 | novartis.email@novartis.com | |
| Novartis Pharmaceuticals | Contact |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Novartis Investigative Site | Recruiting | Riyadh | SAU | 11525 | Saudi Arabia | |
| Novartis Investigative Site |
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|
| 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) | Baseline, week 24 |
| Baseline characteristics-age | Age at baseline (years) | Baseline |
| Baseline characteristics - Ethnicity | Assessment of Participant's ethnicity | Baseline |
| Baseline characteristics - Socio-economic status | Assessment of socio-economic status | Baseline |
| Baseline characteristics - smoking status | Assessment of smoking status | Baseline |
| Baseline characteristics - Family history of HS | Number of participants with family history of HS | Baseline |
| Baseline characteristics - Duration of the disease | Time since- symptom onset and/or diagnosis | Baseline |
| Baseline characteristics - Previous HS-related treatment | Number of participants with Previous HS- related treatment including treatment type | Baseline |
| Baseline characteristics - previous HS-related surgeries | Number of participants with Previous HS- related surgeries including surgery type | Baseline |
| Baseline characteristics - Current or previous use of antibiotic treatment | Number of participants with current or previous use of antibiotic treatment including antibiotic type. | Baseline |
| Baseline characteristics - Time since diagnosis to first treatment and secukinumab treatment | Time from diagnosis to start the first treatment and Time from diagnosis to start of Secukinumab | Baseline |
| Baseline characteristics - concomitant medications | Assessment of concomitant medications | Baseline |
| Baseline characteristics - Hurley Stage | Classification of HS severity assessed by Hurley staging scale, Stage I (Mild) , Stage II (Moderate) and stage III (Severe) | Baseline |
| Baseline characteristics - number of inflammatory nodules, abscesses and draining tunnels/fistula | Number of inflammatory nodules, abscesses and draining tunnels/fistula | Baseline |
| Recruiting |
| Jeddah |
| 21391 |
| Saudi Arabia |
| Novartis Investigative Site | Recruiting | Jeddah | 23311 | Saudi Arabia |
| Novartis Investigative Site | Recruiting | Riyadh | 11211 | Saudi Arabia |
| 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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