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Chinese Psoriasis Real World Evidence Research

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Second Affiliated Hospital, School of Medicine, Zhejiang University

关键词

抽象

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.

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.

日期

最后验证: 05/31/2020
首次提交: 06/25/2020
提交的预估入学人数: 07/06/2020
首次发布: 07/09/2020
上次提交的更新: 07/15/2020
最近更新发布: 07/16/2020
实际学习开始日期: 07/12/2020
预计主要完成日期: 07/12/2030
预计完成日期: 07/29/2030

状况或疾病

Psoriasis

干预/治疗

Other: Psoriasis

-

手臂组

干预/治疗
Psoriasis
This is a non-interventional study (NIS). All the patients diagnosed as psoriasis by the dermatologists in the clinic are included in this study no matter what kind of treatment they adopt.
Other: Psoriasis
This is a non-interventional study (NIS).

资格标准

有资格学习的性别All
取样方式Non-Probability Sample
接受健康志愿者
标准

Inclusion Criteria:

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

Exclusion Criteria:

- None

结果

主要结果指标

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

次要成果指标

1. The percentage of patients who achieved a PASI reduction of 100% (PASI 100) [6 months and 12 months]

PASI100 represents complete clearance.

2. The percentage of patients who achieved a PASI reduction of 75% (PASI 75) [6 months and 12 months]

PASI75 response is the percentage of participants who achieved at least a 75% reduction from baseline in PASI score.

3. The percentage of patients who achieved a PASI reduction of 50% (PASI 50) [6 months and 12 months]

PASI50 response is the percentage of participants who achieved at least a 50% reduction from baseline in PASI score.

4. static Physician Global Assessment (sPGA) = 0 [6 months and 12 months]

static Physician Global Assessment (sPGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4.

5. static Investigator Global Assessment (sIGA) = 0 [6 months and 12 months]

static Investigator Global Assessment (sIGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4.

6. Body surface area (BSA) [6 months and 12 months]

The percentage of BSA represents the area of involvement, which can be estimated by the entire palm of the patient.

7. Dermatology Life Quality Index (DLQI) =0 [6 months and 12 months]

The Dermatology Life Quality Index (DLQI) is a questionnaire used to measure the impact of a skin disease.

8. Adverse Events (AEs) [Up to 12 months]

Number of patients with adverse events

9. Visual Analog Scale (VAS) [6 months and 12 months]

Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 10. The higher score is, the greater discomfortableness participant has.

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