NCT07683065招募中不适用
SEC-HOPE: A Multicenter Retrospective Cohort Study to Estimate Secukinumab Retention Rate in Psoriasis Patients With MASLD
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 4
- 主要终点
- Number of Definitive Discontinuation Events Per Patient-Year
研究概览
简要总结
This study aims to examine the retention rate of secukinumab in adult patients with plaque psoriasis (with or without psoriatic arthritis [PsA]) and metabolic dysfunction-associated steatotic liver disease (MASLD) in routine clinical practice in Spain, as well as hepatic biomarker trajectories. The study will use electronic medical record (EMR) data from multiple Spanish hospitals.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
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 with a first recorded secukinumab prescription between 01 January 2021 and 31 December
- •Patients aged ≥18 years at index date.
- •Patients with no prior secukinumab exposure in available EMR history.
- •Secukinumab must be patient's first-, second-, or third-line biologic therapy for psoriasis/psoriatic arthritis (PsA).
- •Patients with documented administration per Summary of Product Characteristics dosing recommendations (SmPC).
- •Patients with confirmed plaque psoriasis with or without PsA.
- •Patients with at least one cardiometabolic risk factor.
- •Patients with a confirmed MASLD diagnosis.
- •Patients with baseline laboratory data available.
排除标准
- •Patients with evidence of MASLD absence.
- •Patients with malignant liver disease.
- •Patients with a history of liver transplantation.
- •Patients with alcohol use disorder.
- •Patients with other chronic liver diseases.
- •Patients with diseases or treatments which cause thrombocytopenia.
- •Patients with decompensated cirrhosis.
- •Other protocol-defined inclusion/exclusion criteria may apply.
研究组 & 干预措施
Secukinumab Cohort
Adult patients with plaque psoriasis (with or without PsA) and MASLD initiating secukinumab in routine clinical practice in Spain.
结局指标
主要结局
Number of Definitive Discontinuation Events Per Patient-Year
时间窗: Up to 5 years
Definitive discontinuation is defined as the date of first documentation of secukinumab discontinuation or biologic switch, whichever is recorded first.
次要结局
- ALT Level(Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months)
- Platelet Count(Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months)
- Cumulative Incidence of Treatment Discontinuation Due to Lack of Response(Up to 5 years)
- Proportion of Patients who Achieve a Psoriasis Area and Severity Index (PASI) 100(12 and 24 months)
- Proportion of Patients who Achieve a PASI Score ≤ 3(12 and 24 months)
- Cumulative Incidence of a ≥20% Relative Increase in Fibrosis-4 Index (FIB-4) From Baseline(Baseline up to 5 years)
- Proportion of Patients With a Shift in Fibrosis Category(Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months)
- FIB-4 Score(Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months)
- APRI Score(Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months)
- AST Level(Baseline, 12 months, 24 months, 36 months, 48 months, and 60 months)
- Correlation Between Changes in FIB-4 and Changes in PASI(Baseline to 12 and 24 months)
- Correlation Between Changes in APRI and Changes in PASI(Baseline to 12 and 24 months)
研究者
研究点 (4)
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