Chinese Psoriasis Real World Evidence Research

January 4, 2024 updated by: Xiaoyong Man, Second Affiliated Hospital, School of Medicine, Zhejiang University

A Real World Evidence Study in Chinese Psoriasis Patients

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
10000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
      • Beijing, China
        • Recruiting
        • Beijing Children's Hospital Affiliated to Capital Medical University
        • Contact:
      • Chongqing, China
        • Recruiting
        • The First Affiliated Hospital of Chongqing Medical University
        • Contact:
      • Fujian, China
        • Recruiting
        • The First Affiliated Hospital of Fujian Medical University
        • Contact:
      • Gansu, China
        • Recruiting
        • General Hospital of Lanzhou Military Region
        • Contact:
      • Guangdong, China
        • Recruiting
        • Sun Yat-Sen Memorial Hospital
        • Contact:
      • Guangxi, China
        • Recruiting
        • The Peoples' Hospital of Guangxi Zhuang Autonomous Region
        • Contact:
      • Guizhou, China
        • Recruiting
        • The Affiliated Hospital of Guizhou Medical University
        • Contact:
      • Hainan, China
        • Recruiting
        • The Fifth People's Hospital of Hainan Province
        • Contact:
      • Hebei, China
        • Recruiting
        • The First Hospital of Hebei Medical University
        • Contact:
      • Heilongjiang, China
        • Recruiting
        • the Second Affiliated Hospital of Harbin Medical Unviersity
        • Contact:
      • Henan, China
        • Recruiting
        • Henan Provincial Peoples' Hospital
        • Contact:
      • Hohhot, China
        • Recruiting
        • The Affiliated Hospital of Inner Mongolia Medical University
        • Contact:
      • Hubei, China
        • Recruiting
        • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
        • Contact:
      • Hunan, China
        • Recruiting
        • Xiangya Hospital, Central South University
        • Contact:
      • Jiangxi, China
        • Recruiting
        • The Second Affiliated Hospital of Nanchang University
        • Contact:
      • Jilin, China
        • Recruiting
        • Yanbian University Hospital
        • Contact:
      • Nanjing, China
        • Recruiting
        • Institute of Dermatology, Chinese Academy of Medical Sciences
        • Contact:
      • Qinghai, China
        • Recruiting
        • Xining First Hospital
        • Contact:
      • Shandong, China
        • Recruiting
        • Shandong Provincial Hospital for Skin Diseases
        • Contact:
      • Shanghai, China
        • Recruiting
        • Shanghai Dermatology Hospital
        • Contact:
      • Shanxi, China
        • Enrolling by invitation
        • Taiyuan Central Hospital
      • Shanxi, China
        • Recruiting
        • The Second Affiliated Hospital of Xi'an Jiaotong University
        • Contact:
      • Shenyang, China
        • Recruiting
        • The First Hospital of China Medical University
        • Contact:
      • Sichuan, China
        • Recruiting
        • Sichuan Provincial People's Hospital
        • Contact:
      • Tianjin, China
        • Recruiting
        • Tianjin Academy of Traditional Chinese Medicine Affiliated Hospital
        • Contact:
      • Xinjiang, China
        • Recruiting
        • First Affiliated Hospital, School of Medicine, Shihezi University
        • Contact:
      • Yinchuan, China
        • Recruiting
        • General Hospital of Ningxia Medical University
        • Contact:
      • Yunnan, China
        • Recruiting
        • The Second Affiliated Hospital of Kunming Medical University
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • Second Affiliated Hospital, School of Medicine, Zhejiang University
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • None

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Other
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Other: NIS
This is a non-interventional study (NIS).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
6 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The percentage of patients who achieved a PASI reduction of 100% (PASI 100)
Time Frame: 6 months and 12 months
PASI100 represents complete clearance.
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
PASI75 response is the percentage of participants who achieved at least a 75% reduction from baseline in PASI score.
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
PASI50 response is the percentage of participants who achieved at least a 50% reduction from baseline in PASI score.
6 months and 12 months
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.
6 months and 12 months
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.
6 months and 12 months
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.
6 months and 12 months
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.
6 months and 12 months
Adverse Events (AEs)
Time Frame: Up to 12 months
Number of patients with adverse events
Up to 12 months
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.
6 months and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 8, 2020

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 13, 2030

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 30, 2030

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 7, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 10, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 5, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-354

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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