Clinical trial NCT04465838: Chinese Psoriasis Real World Evidence Research
Official title: A Real World Evidence Study in Chinese Psoriasis Patients
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2020-07-10
Enrollment: 10000
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients diagnosed as psoriasis by dermatologist in clinic were under treatment or willing to be treated.

Brief 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.

Detailed 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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* None

Primary outcomes:
measure: The percentage of patients who achieved a PASI reduction of 100% (PASI 100)
timeFrame: 6 months
Secondary outcomes:
measure: The percentage of patients who achieved a PASI reduction of 100% (PASI 100)
timeFrame: 6 months and 12 months
measure: The percentage of patients who achieved a PASI reduction of 75% (PASI 75)
timeFrame: 6 months and 12 months
measure: The percentage of patients who achieved a PASI reduction of 50% (PASI 50)
timeFrame: 6 months and 12 months
measure: static Physician Global Assessment (sPGA) = 0
timeFrame: 6 months and 12 months
measure: static Investigator Global Assessment (sIGA) = 0
timeFrame: 6 months and 12 months
measure: Body surface area (BSA)
timeFrame: 6 months and 12 months
measure: Dermatology Life Quality Index (DLQI) =0
timeFrame: 6 months and 12 months
measure: Adverse Events (AEs)
timeFrame: Up to 12 months
measure: Visual Analog Scale (VAS)
timeFrame: 6 months and 12 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Second Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Beijing
country: China
facility: Beijing Children's Hospital Affiliated to Capital Medical University
city: Chongqing
country: China
facility: the First Affiliated Hospital of Chongqing Medical University
city: Fujian
country: China
facility: the First Affiliated Hospital of Fujian Medical University
city: Gansu
country: China
facility: General Hospital of Lanzhou Military Region
city: Guangdong
country: China
facility: Sun Yat-sen Memorial Hospital
city: Guangxi
country: China
facility: The Peoples' Hospital of Guangxi Zhuang Autonomous Region
city: Guizhou
country: China
facility: the Affiliated Hospital of Guizhou Medical University
city: Hainan
country: China
facility: The Fifth People's Hospital of Hainan Province
city: Hebei
country: China
facility: the First Hospital of Hebei Medical University
city: Heilongjiang
country: China
facility: the Second Affiliated Hospital of Harbin Medical Unviersity
city: Henan
country: China
facility: Henan Provincial Peoples' Hospital
city: Hohhot
country: China
facility: the Affiliated Hospital of Inner Mongolia Medical University
city: Hubei
country: China
facility: Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
city: Hunan
country: China
facility: Xiangya Hospital, Central South University
city: Jiangxi
country: China
facility: the Second Affiliated Hospital of Nanchang University
city: Jilin
country: China
facility: Yanbian University Hospital
city: Nanjing
country: China
facility: Institute of Dermatology, Chinese Academy of Medical Sciences
city: Qinghai
country: China
facility: Xining First Hospital
city: Shandong
country: China
facility: Shandong Provincial Hospital for Skin Diseases
city: Shanghai
country: China
facility: Shanghai Dermatology Hospital
city: Shanxi
country: China
facility: Taiyuan Central Hospital
city: Shanxi
country: China
facility: the Second Affiliated Hospital of Xi'an Jiaotong University
city: Shenyang
country: China
facility: the First hospital of China Medical University
city: Sichuan
country: China
facility: Sichuan Provincial People's Hospital
city: Tianjin
country: China
facility: Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
city: Xinjiang
country: China
facility: First Affiliated Hospital, School of Medicine, Shihezi University
city: Yinchuan
country: China
facility: General Hospital of Ningxia Medical University
city: Yunnan
country: China
facility: the Second Affiliated Hospital of Kunming Medical University
Study officials:
References: