Treatment Patterns and Outcomes Study for Psoriasis (PSO) in Japan
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Distribution of participant background at first visit: Comorbidities
研究概览
简要总结
The purpose of this study is to understand current real-world treatment patterns and clinical outcomes, reasons for switching treatment, and participant characteristics using each systemic psoriasis treatment in Japan.
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
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of psoriasis
- •Can be followed for at least 2 years
- •Treated with any of the following systemic therapy for psoriasis at time of follow-up start: Tumor Necrosis Factor (TNF) inhibitors (infliximab, adalimumab, and certolizumab pegol), Interleukin (IL)-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate
排除标准
- •Enrolled in any clinical trials for psoriasis in their follow-up period
- •Developed psoriatic arthritis, guttate psoriasis, erythrodermic psoriasis, and pustular psoriasis at time of start date
- •Treated with any of the following systemic therapy before they were diagnosed with psoriasis: TNF inhibitors (infliximab, adalimumab, and certolizumab pegol), IL-12/23 inhibitors (ustekinumab), IL-23 inhibitors(guselkumab, risankizumab, and tildrakizumab), IL-17 inhibitors (secukinumab, ixekizumab, and brodalumab), Apremilast, Methotrexate, Cyclosporine, Etretinate
结局指标
主要结局
Distribution of participant background at first visit: Comorbidities
时间窗: At Baseline
Distribution of participant background at first visit: Current status of phototherapy
时间窗: At Baseline
Treatment patterns: Treatment duration of each drug during study period
时间窗: Up to 4 years
Treatment patterns: Number of treatment changes during study period
时间窗: Up to 4 years
Distribution of participant background at first visit: Sex
时间窗: At Baseline
Distribution of participant background at first visit: Age
时间窗: At Baseline
Treatment patterns: Drug names treated during study period
时间窗: Up to 4 years
Treatment patterns: Drug categories treated during study period
时间窗: Up to 4 years
Treatment patterns: PASI at time of start of a new drug
时间窗: Up to 4 years
Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug
时间窗: Up to 4 years
Distribution of participant background at first visit: Duration with psoriasis
时间窗: At Baseline
Treatment patterns: Reason for treatment change during study period
时间窗: Up to 4 years
Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period
时间窗: Up to 4 years
Treatment patterns: Adverse event (AE) at time of withdrawal of some drug
时间窗: Up to 4 years
Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal
时间窗: Up to 4 years
Treatment patterns: Status of phototherapy combination with systemic treatment
时间窗: Up to 4 years
次要结局
- Mean number of drug changes until participants achieve PASI 100 during study period(Up to 4 years)
- Mean period of participants achieve PASI 75 by each systemic treatment(Up to 4 years)
- Distribution of comorbidities that affect treatment choice and change(Up to 4 years)
- Total period until participants achieve PASI 100 during study period(Up to 4 years)
- Mean period of participants achieve PASI 90 by each systemic treatment(Up to 4 years)
- Description of relationship between the reasons for treatment change and period of withdrawal(Up to 4 years)
- Efficacy after re-start treatment measured by PASI(Up to 4 years)
- Distribution of AEs that affect treatment choice and change(Up to 4 years)
- Mean number of drug changes until participants achieve PASI 90 during study period(Up to 4 years)
- Total period until participants achieve PASI 75 during study period(Up to 4 years)
- Mean number of drug changes until participants achieve PASI 75 during study period(Up to 4 years)
- Total period until participants achieve PASI 90 during study period(Up to 4 years)
- Mean period of participants achieve PASI 100 by each systemic treatment(Up to 4 years)