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

A Prospective Study With Induction Dosing Period Followed by a Maintenance Dosing Period to Evaluate the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04912401

Enrollment

100

Registered

2021-06-03

Start date

2020-12-04

Completion date

2025-12-04

Last updated

2024-01-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Etanercept, Psoriasis

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.
Percentage of patients achieved PASI90 at week 36	36 weeks	PASI90: 90% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores.

Countries

China

Contacts

Primary ContactXiao-yong Man

manxy@zju.edu.cn13600516219

Outcome results