NCT02258282Unknown不适用
Safety and Efficacy of Etanercept in Patients With Psoriasis
Chengdu PLA General Hospital1 个研究点 分布在 1 个国家目标入组 80 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks
研究概览
简要总结
The purpose of this study is to evaluate safety and efficacy of etanercept in patients with psoriasis who had an unsatisfactory response to traditional DMARDs.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
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
- •has plaque psoriasis and has shown an unsatisfactory response to traditional DMARDs
- •18 to 75 years old
- •has PGA of 3 or more at Day 0
- •has BSA of 3% or more at Day 0
- •has psoriasis severe enough to be eligible to systemic therapy
- •willing to use an effective method of contraception for at least 30 days before Day 0 and until at least 1 month after the last drug administration;
- •capable of giving informed consent
- •with normal or non clinically significant chest X-ray within 6 months prior to Day 0
- •with negative Purified Protein Derivative (PPD) or Quantiferon TB Gold test within 90 days prior to Day 0
- •female patients of childbearing potential have a negative serum pregnancy test
- •patient is able to start etanercept per the approved product monograph
排除标准
- •has used topical steroids, topical tar preparations, or other anti-psoriatic preparations within the two weeks prior to Day 0 or during the study period
- •has presence of erythrodermic, pustular or guttate psoriasis
- •has had significant infections within the 30 days prior to Day 0
- •has received investigational drugs within the four weeks prior to screening or during the study period
- •has been treated with systemic anti-psoriatic drugs such as steroids, retinoids, cyclosporine, PUVA therapy or methotrexate within the four weeks prior to Day 0 or during the study period
- •received systemic antibiotics within the four weeks prior to Day 0
- •has been treated with ultraviolet light therapy (UVB, nbUVB) within the two weeks prior to Day 0 or during the study period
- •has used infliximab within 14 days of Day 0 or during the study period
- •has used other biologic agents for the treatment of psoriasis besides etanercept 8 weeks prior to Day 0 or during the study period
- •has had an allergic reaction to infliximab
- •has an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition that might cause this study to be detrimental to the patient
- •uncontrolled or severe comorbidities such as poorly controlled diabetes mellitus, NYHA class III or IV heart failure, history of myocardial infarction or cerebrovascular accident or transient ischemic attack within three months of screening visit; unstable angina pectoris
- •uncontrolled hypertension, oxygen-dependent severe pulmonary disease
- •has a known sero-positivity for HIV virus or history of any other immunosuppressive disease
- •has active or chronic Hepatitis B or C
- •has any mycobacterial disease, patient with a chest X-Ray suggestive of tuberculosis or patient taking anti-tuberculosis medication
- •has a known hypersensitivity to etanercept or one of its components
- •has received a live attenuated vaccine within the 12 weeks prior to Day 0 or plans to receive one during the study
- •current pregnancy or lactation
研究组 & 干预措施
Etanercept
Experimental
Patients under the treatment of 50 mg Etanercept
干预措施: Etanercept (Drug)
Control
Sham Comparator
Patients under the treatment of traditional DMARDs
干预措施: Control (Drug)
结局指标
主要结局
Changes from baseline of Physician's Global Assessment (PGA) at 24 weeks
时间窗: At 0 week, 12 weeks, 24 weeks
次要结局
- Mean Body Surface Area (BSA)(At 0 week, 12 weeks, 24 weeks)
- Mean Psoriasis Area and Severity Index (PASI)(At 0 week, 12 weeks, 24 weeks)
研究者
Yang Min
Ph.D
Chengdu PLA General Hospital
研究点 (1)
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