Status:
RECRUITING
the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis
Lead Sponsor:
Second Affiliated Hospital, School of Medicine, Zhejiang University
Conditions:
Psoriasis
Etanercept
Eligibility:
All Genders
18-75 years
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
December 4 2020
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 4 2025
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT04912401
Start Date
December 4 2020
End Date
December 4 2025
Last Update
January 12 2024
Active Locations (40)
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1
2nd Affiliated Hospital, School of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310000
2
First Affiliated Hospital, Zhejiang Medical University
Hangzhou, China
3
Hang Zhou First People's Hospital
Hangzhou, China
4
Hang Zhou Third People's Hospital
Hangzhou, China