NCT04912401招募中不适用
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
Second Affiliated Hospital, School of Medicine, Zhejiang University40 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2020年12月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 40
- 主要终点
- The percentage of patients achieving PASI75 at week 12
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
The percentage of patients achieving PASI75 at week 12
时间窗: 12 weeks
PASI75: 75% improvement from baseline in the Psoriasis Area and Severity Index (PASI) scores. PASI includes desquamation, erythema, and plaque induration/infiltration.
次要结局
- Percentage of patients achieved PASI90 at week 36(36 weeks)
- Percentage of patients achieved PASI90 at week 12(12 weeks)
- Percentage of patients achieved PASI90 at week 24(24 weeks)
研究者
Xiaoyong Man
Principal Investigator, Head of Dermatology
Second Affiliated Hospital, School of Medicine, Zhejiang University
研究点 (40)
Loading locations...
相似试验
终止
1 期
A Phase I Clinical Study to Evaluate the Safety, Tolerability, and Efficacy of LCAR-M23, a CAR-T Cell Therapy Targeting MSLN in Patients With Relapsed and Refractory Epithelial Ovarian CancerEpithelial Ovarian CancerNCT04562298Shanghai East Hospital15
Unknown
4 期
Efficacy and Safety of Rabbit Antithymocyte Globulin 3mg/kg in Kidney Transplant Patients Under Steroid-free and CNI Minimization Maintenance Immunosuppressive RegimenThymoglobulin DoseNCT03088280Hospital Geral de Fortaleza200
已完成
1 期
The Effect of Reduced Liver Function on Selatogrel PharmacokineticsHealthy SubjectsHepatic ImpairmentNCT04406896Viatris Innovation GmbH24
招募中
1 期
Clinical Study of T3011 Intravesical Instillation for Treatment of NMIBC PatientsBladder CancerNCT06427291Fudan University20
进行中（未招募）
1 期
LEARNER- Low dosE AspiRiN prEterm tRial (Angola)Pregnancy RelatedPregnancy ComplicationsSickle Cell DiseasePre-EclampsiaNCT06417411Instituto Nacional de Investigacao em Saude, Angola450