Chinese Psoriasis Real World Evidence Research
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: NIS.
- Who it may be relevant to
- Registry conditions: Psoriasis. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Real World Evidence Study in Chinese Psoriasis Patients
Overview
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.
Interventions
- Other NIS
This is a non-interventional study (NIS).
Primary outcome measures
- The percentage of patients who achieved a PASI reduction of 100% (PASI 100) [Time frame: 6 months]
Secondary outcome measures (9)
- The percentage of patients who achieved a PASI reduction of 100% (PASI 100) [Time frame: 6 months and 12 months]
- The percentage of patients who achieved a PASI reduction of 75% (PASI 75) [Time frame: 6 months and 12 months]
- The percentage of patients who achieved a PASI reduction of 50% (PASI 50) [Time frame: 6 months and 12 months]
- static Physician Global Assessment (sPGA) = 0 [Time frame: 6 months and 12 months]
- static Investigator Global Assessment (sIGA) = 0 [Time frame: 6 months and 12 months]
- Body surface area (BSA) [Time frame: 6 months and 12 months]
- Dermatology Life Quality Index (DLQI) =0 [Time frame: 6 months and 12 months]
- Adverse Events (AEs) [Time frame: Up to 12 months]
- Visual Analog Scale (VAS) [Time frame: 6 months and 12 months]
Eligibility criteria
Inclusion criteria
- all the patients diagnosed as psoriasis by dermatologist in clinic.
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Other
Study locations
China · 29 centers
- Second Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou
- Beijing Children's Hospital Affiliated to Capital Medical University — Beijing
- the First Affiliated Hospital of Chongqing Medical University — Chongqing
- the First Affiliated Hospital of Fujian Medical University — Fujian
- General Hospital of Lanzhou Military Region — Gansu
- Sun Yat-sen Memorial Hospital — Guangdong
- The Peoples' Hospital of Guangxi Zhuang Autonomous Region — Guangxi
- the Affiliated Hospital of Guizhou Medical University — Guizhou
- … and 21 more centers
Identifiers
NCT: NCT04465838 · 2020-354