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

NCT ID: NCT04912401

Last Updated: 2024-01-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-04

Study Completion Date

2025-12-04

Brief Summary

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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.

Detailed Description

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Conditions

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Psoriasis Etanercept

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role lead

Responsible Party

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Xiaoyong Man

Principal Investigator, Head of Dermatology

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, China

Site Status RECRUITING

First Affiliated Hospital, Zhejiang Medical University

Hangzhou, , China

Site Status RECRUITING

Hang Zhou First People's Hospital

Hangzhou, , China

Site Status RECRUITING

Hang Zhou Third People's Hospital

Hangzhou, , China

Site Status RECRUITING

Hospital of dermatology of Xiaoshan

Hangzhou, , China

Site Status RECRUITING

Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University

Hangzhou, , China

Site Status RECRUITING

the People Hospital of Zhejiang Province

Hangzhou, , China

Site Status RECRUITING

Xiaoshan Hospital

Hangzhou, , China

Site Status RECRUITING

Yuhang Fifth People's Hospital

Hangzhou, , China

Site Status RECRUITING

Zhejiang Hospital of Traditional Chinese Medicine

Hangzhou, , China

Site Status RECRUITING

Changxing Dermatology Hospital prevention and Treatment

Huzhou, , China

Site Status RECRUITING

Chinese 72 Hospital

Huzhou, , China

Site Status RECRUITING

Hospital of dermatology of Zhejiang Province

Huzhou, , China

Site Status RECRUITING

Huzhou Central Hospital

Huzhou, , China

Site Status RECRUITING

Huzhou First Hospital

Huzhou, , China

Site Status RECRUITING

the People Hospital of Changxing

Huzhou, , China

Site Status RECRUITING

Jiaxing First Hospital

Jiaxing, , China

Site Status RECRUITING

Rongjun Hospital of Zhejiang Province

Jiaxing, , China

Site Status RECRUITING

Tongxiang Dermatology Hospital prevention and Treatment

Jiaxing, , China

Site Status RECRUITING

Hospital of dermatology of Yiwu

Jinhua, , China

Site Status RECRUITING

Jinhua Central Hospital

Jinhua, , China

Site Status RECRUITING

Jinhua Fifth Hospital

Jinhua, , China

Site Status RECRUITING

the People Hospital of Dongyang

Jinhua, , China

Site Status RECRUITING

Lishui Central Hospital

Lishui, , China

Site Status RECRUITING

the People Hospital of Lishui

Lishui, , China

Site Status RECRUITING

Ningbo Chinese Medical Hospital

Ningbo, , China

Site Status RECRUITING

Ningbo First Hospital

Ningbo, , China

Site Status RECRUITING

Ningbo Sixth Hospital

Ningbo, , China

Site Status RECRUITING

Quzhou Chinese Medical Hospital

Quzhou, , China

Site Status RECRUITING

the People Hospital of Quzhou

Quzhou, , China

Site Status RECRUITING

Shangyu of Chinese Medical Hospital

Shaoxing, , China

Site Status RECRUITING

Shaoxing Central Hospital

Shaoxing, , China

Site Status RECRUITING

Shaoxing Third Hospital

Shaoxing, , China

Site Status RECRUITING

the People Hospital of Shaoxing

Shaoxing, , China

Site Status RECRUITING

Taizhou Central Hospital

Taizhou, , China

Site Status RECRUITING

Wenling Chinese Medical Hospital

Taizhou, , China

Site Status RECRUITING

the First Affiliated Hospital of Wenzhou medical university

Wenzhou, , China

Site Status RECRUITING

the People Hospital of Cangnan

Wenzhou, , China

Site Status RECRUITING

Wenzhou Chinese Medical Hospital

Wenzhou, , China

Site Status RECRUITING

Wenzhou Combinational Hospital of Chinese and Western Medicine

Wenzhou, , China

Site Status RECRUITING

Countries

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China

Central Contacts

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Xiao-yong Man

Role: CONTACT

13600516219

Facility Contacts

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XiaoYong Man, MD

Role: primary

13600516219

Hong Fang

Role: primary

13588035369

Jian Chen

Role: primary

13738080635

Yunyun Shan

Role: primary

13858080025

Kefeng Gu

Role: primary

13967194658

Kejian Zhu

Role: primary

13957178822

Xiaohong Tao

Role: primary

13505811700

Huaizhu Yang

Role: primary

13396711233

Fengming Qi

Role: primary

18668225609

Lili Ma

Role: primary

13858022185

Yueming Xu

Role: primary

13362293928

Yang Chen

Role: primary

15606729818

Xiaobing Yu

Role: primary

13587211491

Huajie Zhong

Role: primary

13867287968

Jianqiang Yang

Role: primary

13587229333

Mingxing Xie

Role: primary

13185279302

Wenhao Yin

Role: primary

13957323606

Chunhua Zhao

Role: primary

13957337520

Manping Wu

Role: primary

13819399780

Yongping Xu

Role: primary

13857979161

Meiyan Wang

Role: primary

13757984755

Dongmei Liu

Role: primary

13335988881

Fuming Zhang

Role: primary

13758968877

Huan Chen

Role: primary

13905881161

Haiming Ning

Role: primary

18957090631

Zhikai Hu

Role: primary

15888569177

Bingjiang Lin

Role: primary

17757461212

Zhongxiao Wu

Role: primary

13806672880

Zhongliang Xu

Role: primary

13587126655

Yan Chen

Role: primary

13567001923

Ke Ye

Role: primary

15167048086

Jianguo Shen

Role: primary

15957595921

Ping Xu

Role: primary

13588507757

Hong Chen

Role: primary

13587321096

Jinguang Chen

Role: primary

13566879800

Renjie Ruan

Role: primary

13858652828

Zhiming Li

Role: primary

15988718867

Zhengan Ding

Role: primary

13706878377

Dongrui Zhao

Role: primary

13806613950

Zhiwei Chen

Role: primary

13806837499

Other Identifiers

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2020-915

Identifier Type: -

Identifier Source: org_study_id

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