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Chinese Psoriasis Real World Evidence Research

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ClinicalTrials.gov Identifier: NCT04465838
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 15, 2021
Sponsor:
Information provided by (Responsible Party):
Xiaoyong Man, Second Affiliated Hospital, School of Medicine, Zhejiang University

Tracking Information
First Submitted Date June 26, 2020
First Posted Date July 10, 2020
Last Update Posted Date July 15, 2021
Actual Study Start Date July 8, 2020
Estimated Primary Completion Date July 13, 2030   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 7, 2020)
The percentage of patients who achieved a PASI reduction of 100% (PASI 100) [ Time Frame: 6 months ]
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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: July 7, 2020)
  • The percentage of patients who achieved a PASI reduction of 100% (PASI 100) [ Time Frame: 6 months and 12 months ]
    PASI100 represents complete clearance.
  • The percentage of patients who achieved a PASI reduction of 75% (PASI 75) [ Time Frame: 6 months and 12 months ]
    PASI75 response is the percentage of participants who achieved at least a 75% reduction from baseline in PASI score.
  • The percentage of patients who achieved a PASI reduction of 50% (PASI 50) [ Time Frame: 6 months and 12 months ]
    PASI50 response is the percentage of participants who achieved at least a 50% reduction from baseline in PASI score.
  • static Physician Global Assessment (sPGA) = 0 [ Time Frame: 6 months and 12 months ]
    static Physician Global Assessment (sPGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4.
  • static Investigator Global Assessment (sIGA) = 0 [ Time Frame: 6 months and 12 months ]
    static Investigator Global Assessment (sIGA) is an assessment of severity of psoriasis on 5-point scale ranging from 0 to 4.
  • Body surface area (BSA) [ Time Frame: 6 months and 12 months ]
    The percentage of BSA represents the area of involvement, which can be estimated by the entire palm of the patient.
  • Dermatology Life Quality Index (DLQI) =0 [ Time Frame: 6 months and 12 months ]
    The Dermatology Life Quality Index (DLQI) is a questionnaire used to measure the impact of a skin disease.
  • Adverse Events (AEs) [ Time Frame: Up to 12 months ]
    Number of patients with adverse events
  • Visual Analog Scale (VAS) [ Time Frame: 6 months and 12 months ]
    Visual Analog Scale (VAS) is used to measure lesion pruritus from 0 to 10. The higher score is, the greater discomfortableness participant has.
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Chinese Psoriasis Real World Evidence Research
Official Title A Real World Evidence Study in Chinese Psoriasis Patients
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.

Study Type Observational
Study Design Observational Model: Other
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Psoriasis
Intervention Other: NIS
This is a non-interventional study (NIS).
Study Groups/Cohorts 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.
Intervention: Other: NIS
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: July 7, 2020)
10000
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 30, 2030
Estimated Primary Completion Date July 13, 2030   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • None
Sex/Gender
Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts
Contact: Xiao-yong Man, MD 13600516219 manxy@zju.edu.com
Listed Location Countries China
Removed Location Countries  
 
Administrative Information
NCT Number NCT04465838
Other Study ID Numbers 2020-354
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Xiaoyong Man, Second Affiliated Hospital, School of Medicine, Zhejiang University
Study Sponsor Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborators Not Provided
Investigators Not Provided
PRS Account Second Affiliated Hospital, School of Medicine, Zhejiang University
Verification Date July 2021