Long Term observAtional, Prospective, Multicenter Study to Collect iN a Real-world populatIon Data on the treatMent Pattern of secukinumAb in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS) (ANIMA)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 436
- 试验地点
- 81
- 主要终点
- Proportion of patients receiving up-titration
研究概览
简要总结
The purpose of this observational, prospective, non-interventional, multicenter, open-label, single arm study in Hidradenitis suppurativa (HS) is to assess the treatment pattern of secukinumab in a flexible dosing regimen and decision influencing factors for flexible dosing in a real-world population over 2 years.
详细描述
The study will collect data from patients during routine secukinumab treatment and will be representative of the real-world patient population eligible for secukinumab treatment in Germany.
In order to attain widespread representation of health care practices related to the use of secukinumab in the approved indication of moderate to severe HS, a broad spectrum of dermatology practices and clinics who are treating patients with HS across Germany will be included.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients eligible for inclusion in this study have to fulfill all of the following criteria at enrollment:
- •Patients who provide written informed consent to participate in the study
- •Male and female patients with ≥18 years of age
- •Diagnosis of clinically unequivocal moderate to severe HS
- •Patients for whom a therapy with secukinumab is medically indicated
- •Documented decision for treatment with marketed secukinumab regardless of this noninterventional study
- •Treatment with secukinumab according to the latest version of SmPC
- •Initial treatment with marketed secukinumab planned for up to 1 week before the baseline visit
排除标准
- •Patients fulfilling any of the following criteria at enrollment are not eligible for inclusion in this study. No additional exclusions may be applied by the investigator, in order to ensure that the study population will be representative of all eligible patients:
- •Patients who have any contraindications, such as a history of or active inflammatory bowel disease (Crohn´s disease, ulcerative colitis), and are not eligible for treatment with secukinumab according to the SmPC
- •Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the study participation
- •Simultaneous participation in any investigational trial or simultaneous participation in another Novartis-sponsored non-interventional study with secukinumab
- •Previous exposure to IL-17 inhibitors
- •For biologic-naïve patients, previous exposure to another biologic drug, such as anti-TNF-α inhibitors
研究组 & 干预措施
secukinumab
Patients being treated for HS with secukinumab according to the summary of product characteristics (SmPC), after the approval of secukinumab has been granted in this indication.
干预措施: secukinumab (Other)
结局指标
主要结局
Proportion of patients receiving up-titration
时间窗: Up to 24 months
Proportion of patients receiving up-titration (q4w-to-q2w)
Time to up-titration and down-titration
时间窗: Up to 2 years
Time to up-titration and down-titration
Number and type of surgical interventions
时间窗: Up to 2 years
Number and type of surgical interventions * minor and major surgical excision; * inpatient, outpatient
Mean reduction of Abscesses and inflammatory nodules (AN) count
时间窗: Up to 24 months
Mean reduction of Abscesses and inflammatory nodules (AN) count
Proportion of patients achieving a 5-point reduction of their Dermatology Life Quality Index (DLQI) questionnaire
时间窗: Up to 24 months
The DLQI is a 10-item general dermatology disability index designed to assess health-related quality of life (HRQoL) in adult subjects with skin diseases such as eczema, psoriasis, acne, and viral warts. The measure is self-administered and includes domains of daily activities, leisure, personal relationships, symptoms and feelings, treatment, and work/school. Each item has four response categories ranging from 0 (not at all) to 3 (very much). "Not relevant" is also a valid response and is scored as 0. The DLQI total score is a sum of the 10 questions. Scores range from 0 to 30, with higher scores indicating greater HRQoL impairment.
Proportion of patients receiving down-titration
时间窗: Up to 24 months
Proportion of patients receiving down-titration (q2w-to-q4w)
Duration of q4w treatment with secukinumab after dose reduction
时间窗: Up to 2 years
Duration of q4w treatment with secukinumab after dose reduction
Proportion of patients who receive more than one up-and/or down titration
时间窗: Up to 24 months
Proportion of patients who receive more than one up-and/or down titration
Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab
时间窗: Up to 2 years
Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)
时间窗: Up to 24 months
The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS
mean change of International Hidradenitis Suppurativa Severity Score System (IHS4)
时间窗: Up to 24 months
The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. HS severity is calculated based on the number of lesions multiplied by their respective score: the IHS4 score (points) = (number of nodules multiplied by 1) + (number of abscesses multiplied by 2) + \[number of draining tunnels (fistulae/sinuses) multiplied by 4\]. A score of 3 or less signifies mild HS, a score of 4-10 signifies moderate HS and a score of 11 or higher signifies severe HS
Proportion of patients achieving a 30% reduction of pain Numerical Rating scale 30 (NRS30)
时间窗: Up to 24 months
The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain ranging from 0 (no skin pain) to 10 (skin pain as bad as you can imagine). To assess this, the patient should concentrate on the pain that his/her skin lesions generate. The Patient's Global Assessment of Skin Pain - NRS will be completed by the subject electronically via a web-based application or in paper form.
次要结局
未报告次要终点