Assessing Short-term Treatment Satisfaction and Quality of Life in Patients With Hidradenitis Suppurativa Initiated on Secukinumab in Routine Clinical Practice in the United Arab Emirates: ILLUMINATE-HS, a Prospective Patient Surve
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 53
- 试验地点
- 5
- 主要终点
- The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Secukinumab
Patients who are newly initiated on treatment with Secukinumab
干预措施: Secukinumab (Other)
结局指标
主要结局
The absolute scores of each of the 4 domains of the Treatment Satisfaction Questionnaire for Medication (TSQM) questionnaire
时间窗: 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
次要结局
- Change from baseline of the Dermatology Life Quality Index (DLQI) Questionnaire(Baseline, Week 24)
- Hurley Stage(Baseline)
- Change from baseline in the Numerical Rating Scale (NRS)(Baseline, Week 24)
- Age (years)(Baseline)
- Gender (male/female)(Baseline)
- Ethnicity(Baseline)
- Weight (kilogram)(Baseline)
- Height (meters)(Baseline)
- Socio-economic status(Baseline)
- Smoking status(Baseline)
- Duration of the disease (time since diagnosis)(Baseline)
- Previous HS-related treatment(Baseline)
- Time since diagnosis to start of the first treatment, and from time since diagnosis to start of Secukinumab(Baseline)
- Number of inflammatory nodules, number of abscesses, and fistulas(Baseline)
- Previous HS-related surgeries(Baseline)
- Previous use of biologic treatment(Baseline)
- Previous and current use of antibiotics treatment(Baseline)