Chinese Psoriasis Real World Evidence Research

Psoriasis Clinical Trial

Official title:

A Real World Evidence Study in Chinese Psoriasis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04465838
• Other study ID #: 2020-354
• Status: Recruiting
• Start date: July 8, 2020
• Est. completion date: July 30, 2030

Study information

• Verified date: January 2024
• Source: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Contact: Xiao-yong Man, MD
• Phone: 13600516219
• Email: manxy[@]zju.edu.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10000
• Est. completion date: July 30, 2030
• Est. primary completion date: July 13, 2030
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• None

Related Conditions & MeSH terms

• Psoriasis

Intervention

Other:
• NIS
This is a non-interventional study (NIS).

Locations

Country	Name	City	State
China	Beijing Children's Hospital Affiliated to Capital Medical University	Beijing
China	the First Affiliated Hospital of Chongqing Medical University	Chongqing
China	the First Affiliated Hospital of Fujian Medical University	Fujian
China	General Hospital of Lanzhou Military Region	Gansu
China	Sun Yat-sen Memorial Hospital	Guangdong
China	The Peoples' Hospital of Guangxi Zhuang Autonomous Region	Guangxi
China	the Affiliated Hospital of Guizhou Medical University	Guizhou
China	The Fifth People's Hospital of Hainan Province	Hainan
China	Second Affiliated Hospital, School of Medicine, Zhejiang University	Hangzhou	Zhejiang
China	the First Hospital of Hebei Medical University	Hebei
China	the Second Affiliated Hospital of Harbin Medical Unviersity	Heilongjiang
China	Henan Provincial Peoples' Hospital	Henan
China	the Affiliated Hospital of Inner Mongolia Medical University	Hohhot
China	Union Hospital, Tongji Medical College, Huazhong University of Science and Technology	Hubei
China	Xiangya Hospital, Central South University	Hunan
China	the Second Affiliated Hospital of Nanchang University	Jiangxi
China	Yanbian University Hospital	Jilin
China	Institute of Dermatology, Chinese Academy of Medical Sciences	Nanjing
China	Xining First Hospital	Qinghai
China	Shandong Provincial Hospital for Skin Diseases	Shandong
China	Shanghai Dermatology Hospital	Shanghai
China	Taiyuan Central Hospital	Shanxi
China	the Second Affiliated Hospital of Xi'an Jiaotong University	Shanxi
China	the First hospital of China Medical University	Shenyang
China	Sichuan Provincial People's Hospital	Sichuan
China	Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital	Tianjin
China	First Affiliated Hospital, School of Medicine, Shihezi University	Xinjiang
China	General Hospital of Ningxia Medical University	Yinchuan
China	the Second Affiliated Hospital of Kunming Medical University	Yunnan

Sponsors (1)

Lead Sponsor	Collaborator
Second Affiliated Hospital, School of Medicine, Zhejiang University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The percentage of patients who achieved a PASI reduction of 100% (PASI 100)	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.	6 months
Secondary	The percentage of patients who achieved a PASI reduction of 100% (PASI 100)	PASI100 represents complete clearance.	6 months and 12 months
Secondary	The percentage of patients who achieved a PASI reduction of 75% (PASI 75)	PASI75 response is the percentage of participants who achieved at least a 75% reduction from baseline in PASI score.	6 months and 12 months
Secondary	The percentage of patients who achieved a PASI reduction of 50% (PASI 50)	PASI50 response is the percentage of participants who achieved at least a 50% reduction from baseline in PASI score.	6 months and 12 months
Secondary	static Physician Global Assessment (sPGA) = 0	static Physician Global Assessment (sPGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4.	6 months and 12 months
Secondary	static Investigator Global Assessment (sIGA) = 0	static Investigator Global Assessment (sIGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4.	6 months and 12 months
Secondary	Body surface area (BSA)	The percentage of BSA represents the area of involvement, which can be estimated by the entire palm of the patient.	6 months and 12 months
Secondary	Dermatology Life Quality Index (DLQI) =0	The Dermatology Life Quality Index (DLQI) is a questionnaire used to measure the impact of a skin disease.	6 months and 12 months
Secondary	Adverse Events (AEs)	Number of patients with adverse events	Up to 12 months
Secondary	Visual Analog Scale (VAS)	Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 10. The higher score is, the greater discomfortableness participant has.	6 months and 12 months