Prospective, Observational, 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) in Routine Clinical Practice in the Russian Federation (ANIMA-R)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 107
- 试验地点
- 19
- 主要终点
- Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)
研究概览
简要总结
ANIMA-R is an observational, prospective, non-interventional, multicenter study to assess real-world effectiveness of secukinumab in the treatment of Hidradenitis Suppurativa (HS).
详细描述
The index date will be the date of secukinumab initiation. During the study, data will be collected from patients receiving routine secukinumab treatment, which is representative of the actual patient population.
The attending physician will decide whether to prescribe secukinumab based on the approved instructions for medical use in a routine clinical setting, regardless of the patient's participation in a non-interventional study.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 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 who provide written informed consent form (ICF) to participate in the study.
- •Male and female.
- •≥ 18 years old.
- •Diagnosis of moderate or severe HS (Hurley stage and IHS4).
- •Patient who initiated treatment with secukinumab no longer than 4 weeks prior to written ICF.
- •Decision for secukinumab prescription was made by the attending physician according to the approved national label during routine clinical practice, regardless of study participation.
排除标准
- •Any medical or psychological condition that may prevent the study participation, based on practitioners' decision-making.
- •Participation in an ongoing clinical trial.
- •Known or suspected severe hypersensitivity for secukinumab, formulation excipients, or injection device components (i.e., latex).
- •Clinically significant infection exacerbation, including active tuberculosis.
- •Patients with active inflammatory bowel disease (IBD).
- •Age <18 years.
- •Pregnancy and breastfeeding.
- •Patients who received any vaccine within 4 weeks prior to secukinumab initiation.
研究组 & 干预措施
Secukinumab
Patients prescribed with secukinumab in the treatment of Hidradenitis Suppurativa
干预措施: Secukinumab (Other)
结局指标
主要结局
Proportion of patients achieving 55% reduction in IHS4 (IHS4-55)
时间窗: 12 months
The International Hidradenitis Suppurativa Severity Scoring System (IHS4) allows for a dynamic assessment of the disease severity both in clinical studies and in real-world clinical setting. The IHS4 is determined by counting nodules, abscesses, and draining tunnels (fistulae/sinuses). IHS4 (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 lower indicates a mild stage of hidradenitis suppurativa, a score of 4-10 indicates a moderate stage, and a score of 11 or higher indicates a severe stage of the disease. The IHS4 severity scoring system assumes that the presence of a draining tunnel (fistula/sinus) is sufficient to classify a case as at least moderate.
次要结局
- Time of initiation of concomitant medication(12 months)
- Duration of discontinuation/pause of secukinumab treatment before surgery(12 months)
- Duration of discontinuation/pause of secukinumab treatment after surgery(12 months)
- Surgery outcome(12 months)
- Lesion spread(Baseline, month 6, month 12)
- Duration of treatment with concomitant medication(12 months)
- Number, type, and outcome of surgical interventions(12 months)
- Timepoint of and reason for surgical intervention(12 months)
- Proportion of patients receiving HS-specific concomitant treatments in combination with secukinumab(12 months)
- Proportion of patients achieving 75% reduction in IHS4 (IHS4-75) and 100% reduction in IHS4 (IHS4-100)(Month 6, month 12)
- Mean change of nodule count(Month 6, month 12)
- Outcome of surgery and adverse events stratified by secukinumab management(12 months)
- Predictors of treatment response(12 months)