NCT07282015招募中不适用
A Prospective Study to Describe the Real-world Treatment Outcomes in Canadian Patients With Moderate-to-severe Hidradenitis Suppurativa Treated With secukInumab (HS-RISE)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 142
- 试验地点
- 15
- 主要终点
- Proportion of patients who experience a change in disease severity classification
研究概览
简要总结
The HS-RISE study aims to assess real-world HS treatment outcomes and patterns, safety of secukinumab, and to describe the baseline characteristics of patients diagnosed with moderate-to- severe HS who are prescribed secukinumab in Canadian routine clinical practice.
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 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must give written, signed, and dated informed consent before any information is collected and any study-related activity is performed.
- •Adult patients at the time of informed consent signature.
- •Patients with the diagnosis of moderate-to-severe HS, as determined by the dermatologist.
- •Patients who have been newly prescribed secukinumab as part of routine clinical care according to the approved Canadian PM. The decision to prescribe secukinumab must be made prior to,and independent of, study participation. First treatment with secukinumab must occur no more than 7 days (≤7 days) prior to Baseline visit.
- •Patients who can understand written and spoken Canadian English or French.
排除标准
- •Any medical or psychological condition in the treating physician's opinion that may prevent the patient from study participation.
- •Patients who have any contraindications to treatment with secukinumab, as defined in the Canadian PM.
- •Patients who have had any prior exposure to secukinumab (i.e., >7 days prior to the baseline visit).
研究组 & 干预措施
Secukinumab
Patients with moderate-to-severe HS who are prescribed secukinumab in Canadian routine clinical practice
结局指标
主要结局
Proportion of patients who experience a change in disease severity classification
时间窗: Baseline, month 12
Proportion of patients who experience a change in disease severity classification from baseline to 12 months, as determined by the International HS Severity Score System (IHS4). Determining IHS4 score requires counting nodules, abscesses and draining tunnels/sinus tracts. A score of 3 or less signifies mild HS, a score of 4 to 10 signifies moderate HS, and a score of 11 or higher signifies severe HS.
次要结局
- Proportion of patients overall who experience a change in disease severity classification(Baseline, Month 3, Month 6)
- Proportion of patients achieving a 55% reduction in International HS Severity Score System (IHS4-55)(Baseline, Month 3, Month 6, Month 12)
- Proportion of patients experiencing HS Clinical Response 50 (HiSCRO50)(Baseline, Month 3, Month 6, Month 12)
- Mean reduction in abscess and inflammatory nodule count(Baseline, Month 3, Month 6, Month 12)
- Descriptive summaries of demographic and clinical variables(Baseline)
- Proportion of patients receiving secukinumab up-titration from every 4 weeks (Q4W) to every 2 weeks (Q2W)(Month 3, Month 6, Month 12)
- Proportion of patients receiving secukinumab down-titration from every 2 weeks (Q2W) to every 4 weeks (Q4W)(Month 3, Month 6, Month 12)
- Time to secukinumab up- and down-titration(Month 3, Month 6, Month 12)
- Proportion of patients experiencing adverse events post-secukinumab initiation(Up to 12 Months)
- Proportion of patients experiencing serious adverse events post-secukinumab initiation(Up to 12 Months)
- Type of adverse events and serious adverse events experienced by patients post-secukinumab initiation(Up to 12 Months)
- Proportion of patients who discontinued secukinumab due to adverse events(Up to 12 Months)
- Proportion of patients receiving additional HS-related therapies(Month 3, Month 6, Month 12)
- Proportion of patients requiring unplanned surgeries(Month 3, Month 6, Month 12)
- Proportion of patients discontinuing secukinumab treatment(Month 3, Month 6, Month 12)
- Reason(s) for secukinumab discontinuation(Up to 12 Months)
- Percentage of no-show appointments which were scheduled as per standard of care(Up to 12 Months)
研究者
研究点 (15)
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