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

Recruiting

• Conditions: Psoriasis; Etanercept

• 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

Study Timeline

• Study Start: 2020-12-04
• Study First Submitted: 2021-03-01
• Study First Submitted QC: 2021-05-31
• Study First Posted: 2021-06-03
• Status Verified: 2024-01
• Last Update Submitted: 2024-01-11
• Last Update Posted: 2024-01-12
• Primary Completion: 2025-12-04
• Study Completion: 2025-12-04

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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 & 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 First People's Hospital; 🇨🇳 Hangzhou, China

Hang Zhou Third 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

the People Hospital of Zhejiang Province; 🇨🇳 Hangzhou, China

Xiaoshan Hospital; 🇨🇳 Hangzhou, China

Yuhang Fifth People's Hospital; 🇨🇳 Hangzhou, China

Zhejiang Hospital of Traditional Chinese Medicine; 🇨🇳 Hangzhou, China

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