Chinese Psoriasis Real World Evidence Research

NCT ID: NCT04465838

Last Updated: 2024-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

10000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-07-08

Study Completion Date

2030-07-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Psoriasis

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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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.

NIS

Intervention Type OTHER

This is a non-interventional study (NIS).

Interventions

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NIS

This is a non-interventional study (NIS).

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Xiaoyong Man

Principal Investigator, Head of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Second Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

Beijing Children's Hospital Affiliated to Capital Medical University

Beijing, , China

Site Status RECRUITING

the First Affiliated Hospital of Chongqing Medical University

Chongqing, , China

Site Status RECRUITING

the First Affiliated Hospital of Fujian Medical University

Fujian, , China

Site Status RECRUITING

General Hospital of Lanzhou Military Region

Gansu, , China

Site Status RECRUITING

Sun Yat-sen Memorial Hospital

Guangdong, , China

Site Status RECRUITING

The Peoples' Hospital of Guangxi Zhuang Autonomous Region

Guangxi, , China

Site Status RECRUITING

the Affiliated Hospital of Guizhou Medical University

Guizhou, , China

Site Status RECRUITING

The Fifth People's Hospital of Hainan Province

Hainan, , China

Site Status RECRUITING

the First Hospital of Hebei Medical University

Hebei, , China

Site Status RECRUITING

the Second Affiliated Hospital of Harbin Medical Unviersity

Heilongjiang, , China

Site Status RECRUITING

Henan Provincial Peoples' Hospital

Henan, , China

Site Status RECRUITING

the Affiliated Hospital of Inner Mongolia Medical University

Hohhot, , China

Site Status RECRUITING

Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

Hubei, , China

Site Status RECRUITING

Xiangya Hospital, Central South University

Hunan, , China

Site Status RECRUITING

the Second Affiliated Hospital of Nanchang University

Jiangxi, , China

Site Status RECRUITING

Yanbian University Hospital

Jilin, , China

Site Status RECRUITING

Institute of Dermatology, Chinese Academy of Medical Sciences

Nanjing, , China

Site Status RECRUITING

Xining First Hospital

Qinghai, , China

Site Status RECRUITING

Shandong Provincial Hospital for Skin Diseases

Shandong, , China

Site Status RECRUITING

Shanghai Dermatology Hospital

Shanghai, , China

Site Status RECRUITING

Taiyuan Central Hospital

Shanxi, , China

Site Status ENROLLING_BY_INVITATION

the Second Affiliated Hospital of Xi'an Jiaotong University

Shanxi, , China

Site Status RECRUITING

the First hospital of China Medical University

Shenyang, , China

Site Status RECRUITING

Sichuan Provincial People's Hospital

Sichuan, , China

Site Status RECRUITING

Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital

Tianjin, , China

Site Status RECRUITING

First Affiliated Hospital, School of Medicine, Shihezi University

Xinjiang, , China

Site Status RECRUITING

General Hospital of Ningxia Medical University

Yinchuan, , China

Site Status RECRUITING

the Second Affiliated Hospital of Kunming Medical University

Yunnan, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiao-yong Man, MD

Role: CONTACT

13600516219

Facility Contacts

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Xiao-Yong Man, MD

Role: primary

13600516219

Zhe Xu

Role: primary

15801449886

Ai-jun Chen

Role: primary

13062377863

Chao Ji

Role: primary

13075959049

Chun-feng He

Role: primary

13919914800

Liang-chun Wang

Role: primary

13926496797

Zhi Xie

Role: primary

15277094610

Hong-guang Lu

Role: primary

13984120866

Shi Gong

Role: primary

13976006125

Guo-qiang Zhang

Role: primary

18531117085

Bing-xue Bai

Role: primary

15114517408

Min Li, MD

Role: primary

13525585301

Jianwen Han

Role: primary

15047838652

Juan Tao

Role: primary

13986278399

Juan Su

Role: primary

15116408921

Ou-gen Liu

Role: primary

13576296646

Lian-hua Zhu

Role: primary

15526770355

Yong Yang

Role: primary

13661267877

Yong-mei Huang

Role: primary

13997291656

Hong Liu

Role: primary

15866796024

Yuling Shi, MD

Role: primary

13816213884

Song-mei Geng

Role: primary

13060423612

Yan Wu

Role: primary

15840213656

Shen Zhu

Role: primary

13983174426

Xiang-jun Kong

Role: primary

18587535831

Jia Zeng

Role: primary

13899518298

Xin-hong Ge

Role: primary

13895011119

Yun Guo

Role: primary

13769111959

Other Identifiers

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2020-354

Identifier Type: -

Identifier Source: org_study_id

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