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A Study of Treatment Patterns and Clinical Outcomes of Psoriasis in Japan

2022年6月2日更新者：Bristol-Myers Squibb

Treatment Patterns and Outcomes Study for Psoriasis (PSO) in Japan

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.

研究概览

地位

完全的

条件

银屑病

研究类型

观察性的

注册 (实际的)

114

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习地点

日本
- Tokyo
  - Minato-ku、Tokyo、日本、1070052
    - Local Institution

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

20年及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

取样方法

非概率样本

研究人群

120 participants, from 2 to 4 institutes which have a central role of psoriasis therapy in Japan, will be entered into the study if they started systemic treatment after 01/01/2017 and followed until either 12/31/2020, death, or lost to follow-up, whichever occurs first.

描述

Inclusion Criteria:

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

Exclusion Criteria:

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

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

团体/队列数

队列和干预

团体/队列
Cohort 1 Participants with psoriasis

研究衡量的是什么？

主要结果指标

结果测量	大体时间
Distribution of participant background at first visit: Age 大体时间：At Baseline	At Baseline
Distribution of participant background at first visit: Sex 大体时间：At Baseline	At Baseline
Distribution of participant background at first visit: Duration with psoriasis 大体时间：At Baseline	At Baseline
Distribution of participant background at first visit: Comorbidities 大体时间：At Baseline	At Baseline
Distribution of participant background at first visit: Current status of phototherapy 大体时间：At Baseline	At Baseline
Treatment patterns: Drug names treated during study period 大体时间：Up to 4 years	Up to 4 years
Treatment patterns: Drug categories treated during study period 大体时间：Up to 4 years	Up to 4 years
Treatment patterns: Number of treatment changes during study period 大体时间：Up to 4 years	Up to 4 years
Treatment patterns: Treatment duration of each drug during study period 大体时间：Up to 4 years	Up to 4 years
Treatment patterns: Duration between withdrawal of one drug and start of a new drug during study period 大体时间：Up to 4 years	Up to 4 years
Treatment patterns: Adverse event (AE) at time of withdrawal of some drug 大体时间：Up to 4 years	Up to 4 years
Treatment patterns: Psoriasis area severity index (PASI) at time of withdrawal 大体时间：Up to 4 years	Up to 4 years
Treatment patterns: PASI at time of start of a new drug 大体时间：Up to 4 years	Up to 4 years
Treatment patterns: PASI improvement from start of one drug to withdrawal of other drug 大体时间：Up to 4 years	Up to 4 years
Treatment patterns: Reason for treatment change during study period 大体时间：Up to 4 years	Up to 4 years
Treatment patterns: Status of phototherapy combination with systemic treatment 大体时间：Up to 4 years	Up to 4 years

次要结果测量

结果测量	措施说明	大体时间
Distribution of comorbidities that affect treatment choice and change 大体时间：Up to 4 years		Up to 4 years
Distribution of AEs that affect treatment choice and change 大体时间：Up to 4 years		Up to 4 years
Mean number of drug changes until participants achieve PASI 75 during study period 大体时间：Up to 4 years	75% reduction in the Psoriasis Area and Severity Index score (PASI 75)	Up to 4 years
Mean number of drug changes until participants achieve PASI 90 during study period 大体时间：Up to 4 years	90% reduction in the Psoriasis Area and Severity Index score (PASI 90)	Up to 4 years
Mean number of drug changes until participants achieve PASI 100 during study period 大体时间：Up to 4 years	100% reduction in the Psoriasis Area and Severity Index score (PASI 100)	Up to 4 years
Total period until participants achieve PASI 75 during study period 大体时间：Up to 4 years		Up to 4 years
Total period until participants achieve PASI 90 during study period 大体时间：Up to 4 years		Up to 4 years
Total period until participants achieve PASI 100 during study period 大体时间：Up to 4 years		Up to 4 years
Mean period of participants achieve PASI 75 by each systemic treatment 大体时间：Up to 4 years		Up to 4 years
Mean period of participants achieve PASI 90 by each systemic treatment 大体时间：Up to 4 years		Up to 4 years
Mean period of participants achieve PASI 100 by each systemic treatment 大体时间：Up to 4 years		Up to 4 years
Description of relationship between the reasons for treatment change and period of withdrawal 大体时间：Up to 4 years		Up to 4 years
Efficacy after re-start treatment measured by PASI 大体时间：Up to 4 years		Up to 4 years

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

Bristol-Myers Squibb

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

有用的网址

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2021年6月25日

初级完成 (实际的)

2021年10月8日

研究完成 (实际的)

2021年10月8日

研究注册日期

首次提交

2021年3月31日

首先提交符合 QC 标准的

2021年3月31日

首次发布 (实际的)

2021年4月1日

研究记录更新

最后更新发布 (实际的)

2022年6月3日

上次提交的符合 QC 标准的更新

2022年6月2日

最后验证

2022年5月1日