the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis

January 11, 2024 updated by: Xiaoyong Man, Second Affiliated Hospital, School of Medicine, Zhejiang University

A Prospective Study With Induction Dosing Period Followed by a Maintenance Dosing Period to Evaluate the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis

This is a prospective, open-label, one-arm study. The study aims to assess the efficacy and safety of Etanercept therapy which help guide the clinical practice in real-world settings.

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.

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.
100

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
      • Hangzhou, China
        • Recruiting
        • First Affiliated Hospital, Zhejiang Medical University
        • Contact:
      • Hangzhou, China
        • Recruiting
        • Hang Zhou First People's Hospital
        • Contact:
      • Hangzhou, China
        • Recruiting
        • Hang Zhou Third People's Hospital
        • Contact:
      • Hangzhou, China
        • Recruiting
        • Hospital of dermatology of Xiaoshan
        • Contact:
      • Hangzhou, China
        • Recruiting
        • Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University
        • Contact:
      • Hangzhou, China
        • Recruiting
        • the People Hospital of Zhejiang Province
        • Contact:
      • Hangzhou, China
      • Hangzhou, China
        • Recruiting
        • Yuhang Fifth People's Hospital
        • Contact:
      • Hangzhou, China
        • Recruiting
        • Zhejiang Hospital of Traditional Chinese Medicine
        • Contact:
      • Huzhou, China
        • Recruiting
        • Changxing Dermatology Hospital prevention and Treatment
        • Contact:
      • Huzhou, China
        • Recruiting
        • Chinese 72 Hospital
        • Contact:
      • Huzhou, China
        • Recruiting
        • Hospital of dermatology of Zhejiang Province
        • Contact:
      • Huzhou, China
        • Recruiting
        • Huzhou Central Hospital
        • Contact:
      • Huzhou, China
        • Recruiting
        • Huzhou First Hospital
        • Contact:
      • Huzhou, China
        • Recruiting
        • the People Hospital of Changxing
        • Contact:
      • Jiaxing, China
        • Recruiting
        • Jiaxing First Hospital
        • Contact:
      • Jiaxing, China
        • Recruiting
        • Rongjun Hospital of Zhejiang Province
        • Contact:
      • Jiaxing, China
        • Recruiting
        • Tongxiang Dermatology Hospital prevention and Treatment
        • Contact:
      • Jinhua, China
        • Recruiting
        • Jinhua Central Hospital
        • Contact:
      • Jinhua, China
        • Recruiting
        • Hospital of dermatology of Yiwu
        • Contact:
      • Jinhua, China
        • Recruiting
        • Jinhua Fifth Hospital
        • Contact:
      • Jinhua, China
        • Recruiting
        • the People Hospital of Dongyang
        • Contact:
      • Lishui, China
        • Recruiting
        • Lishui Central Hospital
        • Contact:
      • Lishui, China
        • Recruiting
        • the People Hospital of Lishui
        • Contact:
      • Ningbo, China
        • Recruiting
        • Ningbo First Hospital
        • Contact:
      • Ningbo, China
        • Recruiting
        • Ningbo Chinese Medical Hospital
        • Contact:
      • Ningbo, China
        • Recruiting
        • Ningbo Sixth Hospital
        • Contact:
      • Quzhou, China
        • Recruiting
        • Quzhou Chinese Medical Hospital
        • Contact:
      • Quzhou, China
        • Recruiting
        • the People Hospital of Quzhou
        • Contact:
      • Shaoxing, China
        • Recruiting
        • Shaoxing Central Hospital
        • Contact:
      • Shaoxing, China
        • Recruiting
        • Shangyu of Chinese Medical Hospital
        • Contact:
      • Shaoxing, China
        • Recruiting
        • Shaoxing Third Hospital
        • Contact:
      • Shaoxing, China
        • Recruiting
        • the People Hospital of Shaoxing
        • Contact:
      • Taizhou, China
        • Recruiting
        • Taizhou Central Hospital
        • Contact:
      • Taizhou, China
        • Recruiting
        • Wenling Chinese Medical Hospital
        • Contact:
      • Wenzhou, China
        • Recruiting
        • The First Affiliated Hospital of Wenzhou Medical University
        • Contact:
      • Wenzhou, China
        • Recruiting
        • the People Hospital of Cangnan
        • Contact:
      • Wenzhou, China
        • Recruiting
        • Wenzhou Chinese Medical Hospital
        • Contact:
      • Wenzhou, China
        • Recruiting
        • Wenzhou Combinational Hospital of Chinese and Western Medicine
        • Contact:
    • Zhejiang
      • Hangzhou, Zhejiang, China, 310000
        • Recruiting
        • 2nd 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

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

N/A

Sampling Method

Non-Probability Sample

Study Population

Patients with moderate to severe psoriasis (PASI>3) and bio-naive

Description

Inclusion Criteria:

1.18 to 75 years of age 2.Moderate to severe chronic psoriasis, BSA≥3% 3.Duration of psoriasis≥6 months 4.Patients must be candidate for systemic therapy or phototherapy 5.No contradiction to Etanercept 6.Informed consent must be obtained 7.For female, ß-hCG test is negative and contraception is accepted

Exclusion Criteria:

  1. Diagnosis of pustular psoriasis, erythroderma psoriasis or drug-induced psoriasis
  2. Having severe infections, including hepatitis, HIV and tuberculosis
  3. No live vaccines 12 weeks before enrollment, through the study and 1 year after the last dose of Etanercept
  4. Having significant allergies to biological agents
  5. Having the previous experience of biologics
  6. Having a history of malignancy
  7. Having contradictions to Etanercept
  8. Refusal of contraception
  9. Having serious or unstable/uncontrolled illnesses

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

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 achieving PASI75 at week 12
Time Frame: 12 weeks
PASI75: 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores. PASI includes desquamation, erythema, and plaque induration/infiltration.
12 weeks

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
Percentage of patients achieved PASI90 at week 12
Time Frame: 12 weeks
PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.
12 weeks
Percentage of patients achieved PASI90 at week 24
Time Frame: 24 weeks
PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.
24 weeks
Percentage of patients achieved PASI90 at week 36
Time Frame: 36 weeks
PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.
36 weeks

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.
December 4, 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.
December 4, 2025

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.
December 4, 2025

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).
March 1, 2021

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.
May 31, 2021

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.
June 3, 2021

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 12, 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 11, 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.
  • 2020-915

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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