评估接受苏金单抗治疗的化脓性汗腺炎患者的短期治疗满意度和生活质量。
评估阿拉伯联合酋长国常规临床实践中接受苏金单抗治疗的化脓性汗腺炎患者的短期治疗满意度和生活质量：ILLUMINATE-HS，一项前瞻性患者调查
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.
研究概览
详细说明
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).
研究类型
注册 (实际的)
联系人和位置
学习地点
-
-
-
Abu Dhabi、阿拉伯联合酋长国
- Novartis Investigative Site
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Al Ain Abu Dhabi、阿拉伯联合酋长国
- Novartis Investigative Site
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Ras al-Khaimah、阿拉伯联合酋长国
- Novartis Investigative Site
-
Sharjah city、阿拉伯联合酋长国
- Novartis Investigative Site
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-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
Patients with Hidradenitis Suppurativa who are newly initiated on Secukinumab, across the United Arab Emirates.
描述
Inclusion Criteria:
- Patient with a confirmed diagnosis of active moderate to severe HS (Hurley Score 2-3)
- Male or Female adult patients ≥ 18 years of age at the time of data collection
- Patient newly initiated on Secukinumab (first dose to coincide within 1 month of the signature of the informed consent)
- Patients with a diagnosis of HS who are currently using antibiotics/ have undergone surgery or not as part of their routine clinical management are eligible for inclusion.
- Patients with a diagnosis of HS who have a history of previous treatment with Adalimumab or any other anti-TNF agent as part of their routine clinical management or biologic naïve are eligible for inclusion.
- Agreed to sign an informed consent to be able to fill in the questionnaires.
Exclusion Criteria:
- Patients not fulfilling any of the abovementioned inclusion criteria.
- Patient's refusal to be included in the study or refusal to sign the informed consent.
学习计划
研究是如何设计的？
设计细节
- 观测模型：OTHER
- 时间观点：PROSPECTIVE
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
|
Secukinumab
Patients who are newly initiated on treatment with Secukinumab |
This is an observational study. There is no treatment allocation. |
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
大体时间：At Week 24
|
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
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire
大体时间：Baseline, Week 24
|
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." |
Baseline, Week 24
|
|
Change from baseline in the Numerical Rating Scale (NRS)
大体时间：Baseline, Week 24
|
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)
大体时间：Baseline
|
Characteristics of Hidradenitis Suppurativa (HS) patients started on Secukinumab |
Baseline
|
|
Gender (male/female)
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Ethnicity
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Weight (kilogram)
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Height (meters)
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Socio-economic status
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Smoking status
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Duration of the disease (time since diagnosis)
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous HS-related treatment
大体时间：Baseline
|
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
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Hurley Stage
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Number of inflammatory nodules, number of abscesses, and fistulas
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous HS-related surgeries
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous use of biologic treatment
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
|
Previous and current use of antibiotics treatment
大体时间：Baseline
|
Characteristics of HS patients started on Secukinumab |
Baseline
|
合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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