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

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

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 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

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

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

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

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)

December 4, 2020

Primary Completion (Estimated)

December 4, 2025

Study Completion (Estimated)

December 4, 2025

Study Registration Dates

First Submitted

March 1, 2021

First Submitted That Met QC Criteria

May 31, 2021

First Posted (Actual)

June 3, 2021

Study Record Updates

Last Update Posted (Actual)

January 12, 2024

Last Update Submitted That Met QC Criteria

January 11, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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