NCT00581165已完成4 期
Evaluating Safety in Patients With Moderate to Severe Psoriasis Treated With Etanercept
Wyeth is now a wholly owned subsidiary of Pfizer0 个研究点目标入组 500 人开始时间: 2006年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 500
- 主要终点
- Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment
研究概览
简要总结
Evaluate (i) safety of etanercept in patients with moderate to severe psoriasis in Spain; (ii) the incidence of adverse events reported in these patients, and (iii) the role that age and concomitant therapy might play in the development of adverse reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed by patients prior to study entry
- •18 years of age or older at screening visit
- •Patients with moderate to severe psoriasis
- •Patients who have failed conventional systemic treatment
- •Patients who have a contraindication to conventional systemic therapy
- •Patients who are intolerant to conventional systemic therapy
- •A negative serum pregnancy test at screening in women of childbearing potential
- •Able to self-inject study drug or have a designee who can do so
- •In the opinion of the investigator, the patient will be able to comply with the requirements of the protocol
排除标准
- 未提供
结局指标
主要结局
Dermatology Quality of Life Index, Psoriasis Quality of Life Index and Physician Global assessment
时间窗: 18 months
次要结局
- Reduction and/or withdrawal of systemic therapies, Proportion of patients with plaque psoriasis achieving PASI 50, 75 and 90 at each evaluation and BSA at each evaluation(18 months)
研究者
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