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临床试验/NCT04465838
NCT04465838招募中不适用

A Real World Evidence Study in Chinese Psoriasis Patients

Second Affiliated Hospital, School of Medicine, Zhejiang University29 个研究点 分布在 1 个国家目标入组 10,000 人开始时间: 2020年7月8日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
10,000
试验地点
29
主要终点
The percentage of patients who achieved a PASI reduction of 100% (PASI 100)

研究概览

简要总结

This research is a multicenter,observational study under real world settings in patients diagnosed as psoriasis by dermatologist in the clinic. As patient's choice of medication should be fully respected, all the patients can choose the treatments they prefer, like phototherapy, traditional systemic therapy or biologics. And the study was conducted to compare the effectiveness among different choices of medication in Chinese psoriasis patients.

详细描述

Psoriasis is a chronic, recurrent inflammatory disease which is caused by heredity, environment and other factors. The typical clinical manifestation are erythematosquamous lesions, and the disease can progress to involve several organs. In view of its complex pathogenesis, there exists various of treatment of psoriasis like traditional systemic drugs and biologics.

This study is an observational, multi-centre study based on real-world evidence. Inclusion criteria is the patients who visit the clinic diagnosed psoriasis by the dermatologist. There existed no exclusion criteria. Information were most collected by a phone application called "Psoriasis New World".

Primary outcome measure is the percentage of patients who achieved a PASI reduction of 100% (PASI 100). And Psoriasis Area and Severity Index includes scores of erythema, infiltration and desquamation, weighted by area of involvement in each regions (head and neck, upper extremities, trunk, lower extremities), with higher PASI scores indicating worse condition. Also, static Physician Global Assessment (sPGA), static Investigator Global Assessment (sIGA), Body surface area (BSA) and Dermatology Life Quality Index (DLQI) are measured to assess the severity of psoriasis and the change of the disease condition. It is important to monitor all the Adverse Events (AEs) over the whole study. In addition, the laboratory examinations of patients such as liver function are also collected.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Prospective

入排标准

性别
All
接受健康志愿者

入选标准

  • all the patients diagnosed as psoriasis by dermatologist in clinic.

排除标准

  • 未提供

结局指标

主要结局

The percentage of patients who achieved a PASI reduction of 100% (PASI 100)

时间窗: 6 months

Psoriasis Area and Severity Index includes scores of erythema, infiltration and desquamation, weighted by area of involvement in each regions (head and neck, upper extremities, trunk, lower extremities), with higher PASI scores indicating worse condition. The percentage of patients who achieved a PASI reduction of 100% (PASI 100) will be measured.

次要结局

  • The percentage of patients who achieved a PASI reduction of 75% (PASI 75)(6 months and 12 months)
  • The percentage of patients who achieved a PASI reduction of 100% (PASI 100)(6 months and 12 months)
  • static Physician Global Assessment (sPGA) = 0(6 months and 12 months)
  • Adverse Events (AEs)(Up to 12 months)
  • Visual Analog Scale (VAS)(6 months and 12 months)
  • The percentage of patients who achieved a PASI reduction of 50% (PASI 50)(6 months and 12 months)
  • Dermatology Life Quality Index (DLQI) =0(6 months and 12 months)
  • static Investigator Global Assessment (sIGA) = 0(6 months and 12 months)
  • Body surface area (BSA)(6 months and 12 months)

研究者

发起方
Second Affiliated Hospital, School of Medicine, Zhejiang University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiaoyong Man

Principal Investigator, Head of Dermatology

Second Affiliated Hospital, School of Medicine, Zhejiang University

研究点 (29)

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