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

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Unknown
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Observational
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04912401
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Second Affiliated Hospital, School of Medicine, Zhejiang University
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

N/A
Principal Investigator Affiliation N/A
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Other
Overall Status Recruiting
Countries China
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Psoriasis, Etanercept

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Hangzhou, Zhejiang, China

Status

Recruiting

Address

2nd Affiliated Hospital, School of Medicine, Zhejiang University

Hangzhou, Zhejiang, 310000

Site Contact

XiaoYong Man, MD

manxy@zju.edu.cn

13600516219

Hangzhou, China

Status

Recruiting

Address

First Affiliated Hospital, Zhejiang Medical University

Hangzhou, ,

Site Contact

Hong Fang

fanghongzy@sina.com

13588035369

Hang Zhou First People's Hospital, Hangzhou, China

Status

Recruiting

Address

Hang Zhou First People's Hospital

Hangzhou, ,

Site Contact

Jian Chen

janejane819@163.com

13738080635

Hang Zhou Third People's Hospital, Hangzhou, China

Status

Recruiting

Address

Hang Zhou Third People's Hospital

Hangzhou, ,

Site Contact

Yunyun Shan

shanyuanyuan7@163.com

13858080025

Hospital of dermatology of Xiaoshan, Hangzhou, China

Status

Recruiting

Address

Hospital of dermatology of Xiaoshan

Hangzhou, ,

Site Contact

Kefeng Gu

apf025@163.com

13967194658

Hangzhou, China

Status

Recruiting

Address

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

Hangzhou, ,

Site Contact

Kejian Zhu

zhukejiansrrsh@126.com

13957178822

the People Hospital of Zhejiang Province, Hangzhou, China

Status

Recruiting

Address

the People Hospital of Zhejiang Province

Hangzhou, ,

Site Contact

Xiaohong Tao

txhtxh@sina.com

13505811700

Xiaoshan Hospital, Hangzhou, China

Status

Recruiting

Address

Xiaoshan Hospital

Hangzhou, ,

Site Contact

Huaizhu Yang

Xsyylaoyang1970@163.com

13396711233

Yuhang Fifth People's Hospital, Hangzhou, China

Status

Recruiting

Address

Yuhang Fifth People's Hospital

Hangzhou, ,

Site Contact

Fengming Qi

xiaozhu_314@163.com

18668225609

Hangzhou, China

Status

Recruiting

Address

Zhejiang Hospital of Traditional Chinese Medicine

Hangzhou, ,

Site Contact

Lili Ma

lilyma163@163.com

13858022185

Huzhou, China

Status

Recruiting

Address

Changxing Dermatology Hospital prevention and Treatment

Huzhou, ,

Site Contact

Yueming Xu

cxxuyueming@163.com

13362293928

Chinese 72 Hospital, Huzhou, China

Status

Recruiting

Address

Chinese 72 Hospital

Huzhou, ,

Site Contact

Yang Chen

98cy@163.com

15606729818

Huzhou, China

Status

Recruiting

Address

Hospital of dermatology of Zhejiang Province

Huzhou, ,

Site Contact

Xiaobing Yu

kava12345@163.com

13587211491

Huzhou Central Hospital, Huzhou, China

Status

Recruiting

Address

Huzhou Central Hospital

Huzhou, ,

Site Contact

Huajie Zhong

zhj0722@sina.com

13867287968

Huzhou First Hospital, Huzhou, China

Status

Recruiting

Address

Huzhou First Hospital

Huzhou, ,

Site Contact

Jianqiang Yang

yjq@zjhu.edu.cn

13587229333

the People Hospital of Changxing, Huzhou, China

Status

Recruiting

Address

the People Hospital of Changxing

Huzhou, ,

Site Contact

Mingxing Xie

xiemingxing2004@163.com

13185279302

Jiaxing First Hospital, Jiaxing, China

Status

Recruiting

Address

Jiaxing First Hospital

Jiaxing, ,

Site Contact

Wenhao Yin

whyin69@sina.com

13957323606

Rongjun Hospital of Zhejiang Province, Jiaxing, China

Status

Recruiting

Address

Rongjun Hospital of Zhejiang Province

Jiaxing, ,

Site Contact

Chunhua Zhao

40392879@qq.com

13957337520

Jiaxing, China

Status

Recruiting

Address

Tongxiang Dermatology Hospital prevention and Treatment

Jiaxing, ,

Site Contact

Manping Wu

770760529@qq.com

13819399780

Hospital of dermatology of Yiwu, Jinhua, China

Status

Recruiting

Address

Hospital of dermatology of Yiwu

Jinhua, ,

Site Contact

Yongping Xu

1375750229@qq.com

13857979161

Jinhua Central Hospital, Jinhua, China

Status

Recruiting

Address

Jinhua Central Hospital

Jinhua, ,

Site Contact

Meiyan Wang

wangmeiyan600@sina.com

13757984755

Jinhua Fifth Hospital, Jinhua, China

Status

Recruiting

Address

Jinhua Fifth Hospital

Jinhua, ,

Site Contact

Dongmei Liu

ldm200370@126.com

13335988881

the People Hospital of Dongyang, Jinhua, China

Status

Recruiting

Address

the People Hospital of Dongyang

Jinhua, ,

Site Contact

Fuming Zhang

jhzhangfuming@163.com

13758968877

Lishui Central Hospital, Lishui, China

Status

Recruiting

Address

Lishui Central Hospital

Lishui, ,

Site Contact

Huan Chen

345158746@qq.com

13905881161

the People Hospital of Lishui, Lishui, China

Status

Recruiting

Address

the People Hospital of Lishui

Lishui, ,

Site Contact

Haiming Ning

57228042@qq.com

18957090631

Ningbo Chinese Medical Hospital, Ningbo, China

Status

Recruiting

Address

Ningbo Chinese Medical Hospital

Ningbo, ,

Site Contact

Zhikai Hu

huzhikai88@126.com

15888569177

Ningbo First Hospital, Ningbo, China

Status

Recruiting

Address

Ningbo First Hospital

Ningbo, ,

Site Contact

Bingjiang Lin

linbingj@163.com

17757461212

Ningbo Sixth Hospital, Ningbo, China

Status

Recruiting

Address

Ningbo Sixth Hospital

Ningbo, ,

Site Contact

Zhongxiao Wu

Wzx2033@163.com

13806672880

Quzhou Chinese Medical Hospital, Quzhou, China

Status

Recruiting

Address

Quzhou Chinese Medical Hospital

Quzhou, ,

Site Contact

Zhongliang Xu

qzxzl1968@163.com

13587126655

the People Hospital of Quzhou, Quzhou, China

Status

Recruiting

Address

the People Hospital of Quzhou

Quzhou, ,

Site Contact

Yan Chen

41995480@qq.com

13567001923

Shangyu of Chinese Medical Hospital, Shaoxing, China

Status

Recruiting

Address

Shangyu of Chinese Medical Hospital

Shaoxing, ,

Site Contact

Ke Ye

yeke1975@163.com

15167048086

Shaoxing Central Hospital, Shaoxing, China

Status

Recruiting

Address

Shaoxing Central Hospital

Shaoxing, ,

Site Contact

Jianguo Shen

pjdsjg@yeah.net

15957595921

Shaoxing Third Hospital, Shaoxing, China

Status

Recruiting

Address

Shaoxing Third Hospital

Shaoxing, ,

Site Contact

Ping Xu

Xpzjsxsy@163.com

13588507757

the People Hospital of Shaoxing, Shaoxing, China

Status

Recruiting

Address

the People Hospital of Shaoxing

Shaoxing, ,

Site Contact

Hong Chen

chhong68@yeah.net

13587321096

Taizhou Central Hospital, Taizhou, China

Status

Recruiting

Address

Taizhou Central Hospital

Taizhou, ,

Site Contact

Jinguang Chen

373897482@qq.com

13566879800

Wenling Chinese Medical Hospital, Taizhou, China

Status

Recruiting

Address

Wenling Chinese Medical Hospital

Taizhou, ,

Site Contact

Renjie Ruan

632495946@qq.com

13858652828

Wenzhou, China

Status

Recruiting

Address

the First Affiliated Hospital of Wenzhou medical university

Wenzhou, ,

Site Contact

Zhiming Li

651911747@qq.com

15988718867

the People Hospital of Cangnan, Wenzhou, China

Status

Recruiting

Address

the People Hospital of Cangnan

Wenzhou, ,

Site Contact

Zhengan Ding

191993635@qq.com

13706878377

Wenzhou Chinese Medical Hospital, Wenzhou, China

Status

Recruiting

Address

Wenzhou Chinese Medical Hospital

Wenzhou, ,

Site Contact

Dongrui Zhao

635226547@qq.com

13806613950

Wenzhou, China

Status

Recruiting

Address

Wenzhou Combinational Hospital of Chinese and Western Medicine

Wenzhou, ,

Site Contact

Zhiwei Chen

13958903891@163.com

13806837499

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