the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis
- Conditions
- PsoriasisEtanercept
- Registration Number
- NCT04912401
- Lead Sponsor
- Second Affiliated Hospital, School of Medicine, Zhejiang University
- Brief Summary
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
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 100
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
- Diagnosis of pustular psoriasis, erythroderma psoriasis or drug-induced psoriasis
- Having severe infections, including hepatitis, HIV and tuberculosis
- No live vaccines 12 weeks before enrollment, through the study and 1 year after the last dose of Etanercept
- Having significant allergies to biological agents
- Having the previous experience of biologics
- Having a history of malignancy
- Having contradictions to Etanercept
- Refusal of contraception
- Having serious or unstable/uncontrolled illnesses
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The percentage of patients achieving PASI75 at week 12 12 weeks PASI75: 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores. PASI includes desquamation, erythema, and plaque induration/infiltration.
- Secondary Outcome Measures
Name Time Method Percentage of patients achieved PASI90 at week 36 36 weeks PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.
Percentage of patients achieved PASI90 at week 12 12 weeks PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.
Percentage of patients achieved PASI90 at week 24 24 weeks PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.
Trial Locations
- Locations (40)
2nd Affiliated Hospital, School of Medicine, Zhejiang University
🇨🇳Hangzhou, Zhejiang, China
First Affiliated Hospital, Zhejiang Medical University
🇨🇳Hangzhou, China
Hang Zhou Third People's Hospital
🇨🇳Hangzhou, China
the People Hospital of Zhejiang Province
🇨🇳Hangzhou, China
Xiaoshan Hospital
🇨🇳Hangzhou, China
Yuhang Fifth People's Hospital
🇨🇳Hangzhou, China
Chinese 72 Hospital
🇨🇳Huzhou, China
Changxing Dermatology Hospital prevention and Treatment
🇨🇳Huzhou, China
Hospital of dermatology of Zhejiang Province
🇨🇳Huzhou, China
the People Hospital of Changxing
🇨🇳Huzhou, China
Jiaxing First Hospital
🇨🇳Jiaxing, China
Rongjun Hospital of Zhejiang Province
🇨🇳Jiaxing, China
Hospital of dermatology of Yiwu
🇨🇳Jinhua, China
Jinhua Fifth Hospital
🇨🇳Jinhua, China
the People Hospital of Dongyang
🇨🇳Jinhua, China
the People Hospital of Lishui
🇨🇳Lishui, China
Ningbo First Hospital
🇨🇳Ningbo, China
Ningbo Chinese Medical Hospital
🇨🇳Ningbo, China
Quzhou Chinese Medical Hospital
🇨🇳Quzhou, China
the People Hospital of Quzhou
🇨🇳Quzhou, China
Shaoxing Central Hospital
🇨🇳Shaoxing, China
Taizhou Central Hospital
🇨🇳Taizhou, China
Hang Zhou First People's Hospital
🇨🇳Hangzhou, China
Hospital of dermatology of Xiaoshan
🇨🇳Hangzhou, China
Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University
🇨🇳Hangzhou, China
Zhejiang Hospital of Traditional Chinese Medicine
🇨🇳Hangzhou, China
Huzhou Central Hospital
🇨🇳Huzhou, China
Huzhou First Hospital
🇨🇳Huzhou, China
Tongxiang Dermatology Hospital prevention and Treatment
🇨🇳Jiaxing, China
Jinhua Central Hospital
🇨🇳Jinhua, China
Lishui Central Hospital
🇨🇳Lishui, China
Ningbo Sixth Hospital
🇨🇳Ningbo, China
Shangyu of Chinese Medical Hospital
🇨🇳Shaoxing, China
Shaoxing Third Hospital
🇨🇳Shaoxing, China
the People Hospital of Shaoxing
🇨🇳Shaoxing, China
Wenling Chinese Medical Hospital
🇨🇳Taizhou, China
the First Affiliated Hospital of Wenzhou medical university
🇨🇳Wenzhou, China
the People Hospital of Cangnan
🇨🇳Wenzhou, China
Wenzhou Chinese Medical Hospital
🇨🇳Wenzhou, China
Wenzhou Combinational Hospital of Chinese and Western Medicine
🇨🇳Wenzhou, China