NCT07543419招募中不适用
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) Within the Italian Population (ANIMA - Italy)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 250
- 试验地点
- 16
- 主要终点
- Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) during the observational period.
研究概览
简要总结
The aim of this study is to generate real-world evidence to fill knowledge gaps regarding the response to secukinumab in patients with moderate to severe HS, its treatment patterns, the clinical characteristics of patients on secukinumab, healthcare resource utilization and the economic impact of HS in Italy.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Study participants eligible for inclusion in this study must meet all the following criteria:
- •1. Male and Female patients who provide written informed consent and privacy form (ICF&PF) to participate in the study.
- •2. Aged ≥ 18 years at ICF&PF signature.
- •Patients with moderate or severe HS (IHS4 and/or Hurley staging system, as assessed by the investigators) at index date.
- •4. The start of secukinumab is within 30 days after the ICF&PF signature (enrolment), as per local standard clinical practice. Patients were not treated with secukinumab before enrolment within the Managed Access Program (MAP). The initiation of secukinumab is based on dermatologist's own practice, regardless of study participation.
- •For HRU and economic burden only:
- •5. Patients who provide written ICF&PF to allow the use of secondary (administrative) data for the purposes of this study.
- •6. Patients with more than 12 months of residence inside the area of competence of the LHU (applicable only to study sites associated with the 6 LHUs).
排除标准
- •Study participants meeting any of the following criteria are not eligible for inclusion in this study:
- •7. Participation in an ongoing clinical trial.
- •Any medical or psychological condition that may prevent study participation, based on practitioners' decision-making.
- •For HRU and economic burden only:
- •9. Patients will be excluded if the unique identifier does not allow them to be identified in the LHU administrative databases related to the site where they were enrolled.
结局指标
主要结局
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) during the observational period.
时间窗: Baseline,6 months and 1 and 1,5 years after initiation of secukinumab
Proportion of patients achieving International Hidradenitis Suppurativa Severity Score System 55% reduction(IHS4-55) during the observational period. The IHS4 is an exclusively physician-based, clinical scoring system for dynamic assessment of HS severity. Determining IHS4 requires counting nodules, abscesses and draining tunnels/sinus tracts, which is easy to calculate. The IHS4 score is calculated as the number of nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (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
次要结局
- Duration of discontinuation/pause of secukinumab treatment after surgery(Up to 1.5 years after initiation of secukinumab)
- Reduction in the number of surgical procedures(Up to 1.5 years after initiation of secukinumab)
- Identification of potential predictors using multivariable analysis(Up to 1.5 years after initiation of secukinumab treatment)
- Proportion of patients achieving 55% reduction in IHS4 (IHS4-55) stratified by dosing(6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)(6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Proportion of patients achieving 50% reduction in HiSCR (HiSCR-50) and 75% reduction in HiSCR (HiSCR-75)(6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Number, type, and localization of HS lesions(baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Change of total abscess and inflammatory nodule count(6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Proportion of patients receiving up-titration(Within 6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Proportion of patients receiving down-titration(within 6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Time to up-titration and down-titration(Up to 1.5 years)
- Proportion of patients switching from q4w to q2w treatment(6 months and 1.5 years after initiation of secukinumab treatment)
- Proportion of patients who receive more than one up- and/or down-titration(within 6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Demographics of adult patients with moderate or severe HS(Baseline)
- Proportion of patients achieving a 5-point reduction of Dermatology life quality index (DLQI) score.(6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Change in DLQI score from baseline(Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab)
- Clinical characteristics of adult patients with moderate to severe HS(Up to 1.5 years)
- Proportion of patients with new draining tunnel(6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Number of areas affected and proportion of patients with additional area involvement(6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab(Up to 1.5 years)
- Time of initiation of concomitant medications(Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Duration of treatment with concomitant medications(Up to 1.5 years)
- Proportion of patients undergoing tapering of concomitant medications(Baseline, 6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Number and type of surgical interventions(6 months, 1 and 1.5 years after initiation of secukinumab)
- Reason for surgical intervention(Up to 1.5 years after initiation of secukinumab)
- Duration of discontinuation/pause of secukinumab treatment before surgery(Up to 1.5 years after initiation of secukinumab)
- Descriptive statistics of pain(6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Proportion of patients achieving a 30% reduction of Pain Numerical Rating scale (NRS30)(6 months, 1 and 1.5 years after initiation of secukinumab treatment)
- Number of patients with secukinumab AEs in routine clinical practice(Up to 1.5 years after initiation of secukinumab treatment)
- Hospital Anxiety and Depression Scale [HADS] score(6 months, 1 and 1.5 years after secukinumab initiation)
- Healthcare Resource Utilization of adult patients with HS(2 months before and 12 months after secukinumab treatment initiation)
- Costs of HS covered by the Italian National Health System(12 months before and 12 months after secukinumab treatment initiation)
- Direct costs not covered by the SSN and indirect costs of HS(12 months before and 12 months after secukinumab treatment initiation)
- Analysis on HS-related surgeries per patient and related direct costs covered by SSN(12 months after secukinumab treatment initiation)
研究者
研究点 (16)
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