Chinese Psoriasis Real World Evidence Research
关键词
抽象
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
干预/治疗
Other: Psoriasis
相
手臂组
臂 | 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 | 是 |
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]
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]
2. The percentage of patients who achieved a PASI reduction of 75% (PASI 75) [6 months and 12 months]
3. The percentage of patients who achieved a PASI reduction of 50% (PASI 50) [6 months and 12 months]
4. static Physician Global Assessment (sPGA) = 0 [6 months and 12 months]
5. static Investigator Global Assessment (sIGA) = 0 [6 months and 12 months]
6. Body surface area (BSA) [6 months and 12 months]
7. Dermatology Life Quality Index (DLQI) =0 [6 months and 12 months]
8. Adverse Events (AEs) [Up to 12 months]
9. Visual Analog Scale (VAS) [6 months and 12 months]