Clinical trial NCT04912401: the Efficacy and Safety of Etanercept （Yi Sai Pu) in Chinese Patients With Moderate-to-Severe Psoriasis
Official title: 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
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Psoriasis
Etanercept
Lead sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University
Sponsor class: OTHER
First posted: 2021-06-03
Enrollment: 100
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with moderate to severe psoriasis (PASI\>3) and bio-naive

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 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

Primary outcomes:
measure: The percentage of patients achieving PASI75 at week 12
timeFrame: 12 weeks
Secondary outcomes:
measure: Percentage of patients achieved PASI90 at week 12
timeFrame: 12 weeks
measure: Percentage of patients achieved PASI90 at week 24
timeFrame: 24 weeks
measure: Percentage of patients achieved PASI90 at week 36
timeFrame: 36 weeks
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: 2nd Affiliated Hospital, School of Medicine, Zhejiang University
state: Zhejiang
city: Hangzhou
country: China
facility: First Affiliated Hospital, Zhejiang Medical University
city: Hangzhou
country: China
facility: Hang Zhou First People's Hospital
city: Hangzhou
country: China
facility: Hang Zhou Third People's Hospital
city: Hangzhou
country: China
facility: Hospital of dermatology of Xiaoshan
city: Hangzhou
country: China
facility: Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University
city: Hangzhou
country: China
facility: the People Hospital of Zhejiang Province
city: Hangzhou
country: China
facility: Xiaoshan Hospital
city: Hangzhou
country: China
facility: Yuhang Fifth People's Hospital
city: Hangzhou
country: China
facility: Zhejiang Hospital of Traditional Chinese Medicine
city: Huzhou
country: China
facility: Changxing Dermatology Hospital prevention and Treatment
city: Huzhou
country: China
facility: Chinese 72 Hospital
city: Huzhou
country: China
facility: Hospital of dermatology of Zhejiang Province
city: Huzhou
country: China
facility: Huzhou Central Hospital
city: Huzhou
country: China
facility: Huzhou First Hospital
city: Huzhou
country: China
facility: the People Hospital of Changxing
city: Jiaxing
country: China
facility: Jiaxing First Hospital
city: Jiaxing
country: China
facility: Rongjun Hospital of Zhejiang Province
city: Jiaxing
country: China
facility: Tongxiang Dermatology Hospital prevention and Treatment
city: Jinhua
country: China
facility: Hospital of dermatology of Yiwu
city: Jinhua
country: China
facility: Jinhua Central Hospital
city: Jinhua
country: China
facility: Jinhua Fifth Hospital
city: Jinhua
country: China
facility: the People Hospital of Dongyang
city: Lishui
country: China
facility: Lishui Central Hospital
city: Lishui
country: China
facility: the People Hospital of Lishui
city: Ningbo
country: China
facility: Ningbo Chinese Medical Hospital
city: Ningbo
country: China
facility: Ningbo First Hospital
city: Ningbo
country: China
facility: Ningbo Sixth Hospital
city: Quzhou
country: China
facility: Quzhou Chinese Medical Hospital
city: Quzhou
country: China
facility: the People Hospital of Quzhou
city: Shaoxing
country: China
facility: Shangyu of Chinese Medical Hospital
city: Shaoxing
country: China
facility: Shaoxing Central Hospital
city: Shaoxing
country: China
facility: Shaoxing Third Hospital
city: Shaoxing
country: China
facility: the People Hospital of Shaoxing
city: Taizhou
country: China
facility: Taizhou Central Hospital
city: Taizhou
country: China
facility: Wenling Chinese Medical Hospital
city: Wenzhou
country: China
facility: the First Affiliated Hospital of Wenzhou medical university
city: Wenzhou
country: China
facility: the People Hospital of Cangnan
city: Wenzhou
country: China
facility: Wenzhou Chinese Medical Hospital
city: Wenzhou
country: China
facility: Wenzhou Combinational Hospital of Chinese and Western Medicine
Study officials:
References: