Patient's Perspective on the Evolution of Hidradenitis Suppurativa Burden After Secukinumab Initiation: a French Multicentric Prospective Observational Study
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 192
- 试验地点
- 22
- 主要终点
- Proportion of patients achieving at least 30% reduction of the NRS score for at least one the assessed symptoms
研究概览
简要总结
The primary objective of this non-interventional study is to describe the evolution of Hidradenitis suppurativa (HS) symptoms 12 months after secukinumab initiation based on the patients' assessment of pain, oozing, and bad smell.
详细描述
This study is a prospective (primary data), national, descriptive, non-interventional, multicentre study conducted by medical practice and hospital-based dermatologists across different geographical regions in France.
This real-world study does not change the physician-patient relationship or patient management or follow-up. Physicians remain free with their prescriptions and patient follow-up procedures. In fact, secukinumab initiation and all treatment decisions will be made according to routine medical care and independently of study participation.
Recruited patients will be longitudinally followed-up for the duration of the study, up to 24 months (± 3 months) after secukinumab initiation or secukinumab treatment discontinuation before the end of the 24 months of follow-up (early discontinuation).
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
- •Male and female patients ≥ 18 years old,
- •Patients who do not object to participation in the study,
- •Diagnosis of HS clinically confirmed,
- •Initiation of secukinumab treatment for HS in compliance with the summary of product characteristics,
- •The physician's decision to initiate secukinumab has been taken according to his/her own practice and regardless of study participation.
排除标准
- •Patients with any medical or psychological condition which, in the physician's opinion, may prevent participation in the study,
- •Patients participating in a clinical trial.
研究组 & 干预措施
secukinumab
Patients prescribed with secukinumab
干预措施: secukinumab (Other)
结局指标
主要结局
Proportion of patients achieving at least 30% reduction of the NRS score for at least one the assessed symptoms
时间窗: Baseline, month 12
Patients will provide an assessment of pain, oozing and bad smell based on three numeric rating scales (NRS). The most common form of the scale is a horizontal line with a numeric scale ranging from 0 to 10, 0 corresponding to "no symptoms" and 10 being the worst possible symptom. At each visit, these three assessments will cover the last seven days.
次要结局
- Proportion of patients with stable/increased/decreased dressing used since the baseline visit(Baseline, month 3, month 6, month 18 and month 24)
- Proportion of patients who achieved at least a 30% reduction in the NRS score (pruritus)(Baseline, month 3, month 6, month 18 and month 24)
- Proportion of patients receiving at least one medication for HS(Month 3, month 6, month 18 and month 24)
- Proportion of patients who had a surgical procedure(Up to 24 months)
- Proportion of patients receiving up-titration or down-titration(Month 3, month 6, month 12, month 18 and month 24)
- Time spent under each treatment regimen(Up to 24 months)
- Proportion of patients with at least one temporary discontinuation(Up to 24 months)
- Proportion of patients achieving a reduction in IHS4(Baseline, month 3, month 6, month 12, month 18 and month 24)
- Evolution of AN count(Baseline, month 3, month 6, month 12, month 18 and month 24)
- Percentages of patients with onset or worsening of flares(Baseline, month 3, month 6, month 18 and month 24)
- Number of patients by reasons for secukinumab initiation(Baseline)
- Absenteeism due to Hidradenitis Suppurativa(Baseline, month 3, month 6, month 18 and month 24)
- Proportion of patients achieving at least a 5-point reduction of FDLQI compared to the baseline(Baseline, month 3, month 6, month 18 and month 24)
- Secukinumab dose regimen prescribed at baseline(Baseline)
- Proportion of patients having stopped at tobacco, alcohol and cannabis use(Baseline, month 3, month 6, month 18 and month 24)
- Total duration of secukinumab treatment(Up to 24 months)
- Proportion of patients taking all prescribed doses(Up to 24 months)
- Proportion of patients achieving at least a 30% reduction of NRS(Baseline, month 3, month 6, month 18 and month 24)
- Proportion of patients achieving at least a 5-point reduction of the Dermatology Life Quality Index (DLQI)(Baseline, month 3, month 6, month 18 and month 24)
- Proportion of patients maintaining the improvement up to 24 months of the response of the Impact of Hidradenitis Suppurativa on daily life compared to baseline(Baseline, up to 24 months)