Evaluating Etanercept for treating moderate-to-severe psoriasis in Chinese patients
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
This study is testing if the medication Etanercept can help Chinese patients aged 18 to 75 with moderate-to-severe psoriasis feel better and improve their skin over time.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital, School of Medicine, Zhejiang University Academic / other |
| Locations | 40 sites (Hangzhou, Zhejiang and 39 other locations) |
| Trial ID | NCT04912401 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy and safety of Etanercept in patients with moderate-to-severe chronic psoriasis. It is a prospective, open-label, one-arm study designed to gather real-world data that can guide clinical practice. Eligible participants will be those aged 18 to 75 with a significant psoriasis burden, and the study will monitor their response to Etanercept therapy over time.
Who should consider this trial
Good fit: Ideal candidates are Chinese patients aged 18 to 75 with moderate to severe chronic psoriasis who are candidates for systemic therapy or phototherapy.
Not a fit: Patients with pustular psoriasis, erythroderma psoriasis, or those with severe infections may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide effective treatment options for patients suffering from moderate-to-severe psoriasis.
How similar studies have performed: Other studies have shown positive outcomes with Etanercept in treating psoriasis, indicating that this approach is supported by existing evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Hangzhou, Zhejiang and 39 other locations
- 2nd Affiliated Hospital, School of Medicine, Zhejiang University — Hangzhou, Zhejiang, China (Recruiting)
- First Affiliated Hospital, Zhejiang Medical University — Hangzhou, China (Recruiting)
- Hang Zhou First People's Hospital — Hangzhou, China (Recruiting)
- Hang Zhou Third People's Hospital — Hangzhou, China (Recruiting)
- Hospital of dermatology of Xiaoshan — Hangzhou, China (Recruiting)
- Sir Run Run Shaw Hospital of College of Medicine of Zhejiang University — Hangzhou, China (Recruiting)
- the People Hospital of Zhejiang Province — Hangzhou, China (Recruiting)
- Xiaoshan Hospital — Hangzhou, China (Recruiting)
- Yuhang Fifth People's Hospital — Hangzhou, China (Recruiting)
- Zhejiang Hospital of Traditional Chinese Medicine — Hangzhou, China (Recruiting)
- Changxing Dermatology Hospital prevention and Treatment — Huzhou, China (Recruiting)
- Chinese 72 Hospital — Huzhou, China (Recruiting)
- Hospital of dermatology of Zhejiang Province — Huzhou, China (Recruiting)
- Huzhou Central Hospital — Huzhou, China (Recruiting)
- Huzhou First Hospital — Huzhou, China (Recruiting)
- the People Hospital of Changxing — Huzhou, China (Recruiting)
- Jiaxing First Hospital — Jiaxing, China (Recruiting)
- Rongjun Hospital of Zhejiang Province — Jiaxing, China (Recruiting)
- Tongxiang Dermatology Hospital prevention and Treatment — Jiaxing, China (Recruiting)
- Hospital of dermatology of Yiwu — Jinhua, China (Recruiting)
- Jinhua Central Hospital — Jinhua, China (Recruiting)
- Jinhua Fifth Hospital — Jinhua, China (Recruiting)
- the People Hospital of Dongyang — Jinhua, China (Recruiting)
- Lishui Central Hospital — Lishui, China (Recruiting)
- the People Hospital of Lishui — Lishui, China (Recruiting)
- Ningbo Chinese Medical Hospital — Ningbo, China (Recruiting)
- Ningbo First Hospital — Ningbo, China (Recruiting)
- Ningbo Sixth Hospital — Ningbo, China (Recruiting)
- Quzhou Chinese Medical Hospital — Quzhou, China (Recruiting)
- the People Hospital of Quzhou — Quzhou, China (Recruiting)
- Shangyu of Chinese Medical Hospital — Shaoxing, China (Recruiting)
- Shaoxing Central Hospital — Shaoxing, China (Recruiting)
- Shaoxing Third Hospital — Shaoxing, China (Recruiting)
- the People Hospital of Shaoxing — Shaoxing, China (Recruiting)
- Taizhou Central Hospital — Taizhou, China (Recruiting)
- Wenling Chinese Medical Hospital — Taizhou, China (Recruiting)
- the First Affiliated Hospital of Wenzhou medical university — Wenzhou, China (Recruiting)
- the People Hospital of Cangnan — Wenzhou, China (Recruiting)
- Wenzhou Chinese Medical Hospital — Wenzhou, China (Recruiting)
- Wenzhou Combinational Hospital of Chinese and Western Medicine — Wenzhou, China (Recruiting)
Study contacts
- Study coordinator: Xiao-yong Man
- Email: manxy@zju.edu.cn
- Phone: 13600516219
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.