NCT00332332已完成4 期
Canadian Assessment of Patient Outcomes and Effectiveness of Enbrel (Etanercept) in Psoriasis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 246
- 主要终点
- Participants With a Status of Mild or Better on Physician Global Assessment at Month 12
研究概览
简要总结
The purpose of this study is to evaluate the use of etanercept (Enbrel®) in the treatment of psoriasis in patients for a period of up to 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •18 years of age or older at baseline
- •Moderate to severe plaque psoriasis at baseline with a rating of moderate, marked or severe on the Physician Global Assessment (score of 3, 4 or 5)
- •Able to start Enbrel (Etanercept) therapy per the approved product monograph
排除标准
- •Active infections at the initiation of Enbrel therapy.
- •Evidence of skin conditions (i.e. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- •Psoralen plus ultraviolet A radiation (PUVA) within 4 weeks or ultraviolet light B (UVB) therapy within 2 weeks of study drug initiation.
- •Oral retinoids, cyclosporine, methotrexate, or any other systemic anti-psoriasis therapy within 4 weeks or efalizumab (Raptiva®) within 8 weeks of study drug initiation and during the study period.
- •Topical Vitamin A or D analog preparations, or anthralin within 2 weeks of study drug initiation and during the study period.
- •Have received Remicade® (infliximab), Humira® (adalimumab) or Amevive®(alefacept) within 3 months before the initiation of study medication or during the study period.
结局指标
主要结局
Participants With a Status of Mild or Better on Physician Global Assessment at Month 12
时间窗: Month 12
The number of participants with a status of mild or better (score of 0, 1 or 2) on the Physician Global Assessment (PGA) of psoriasis at Month 12. This scale ranges from 0 to 5, with 0 = best outcome.
次要结局
- Percent Change From Baseline to Month 12 in Patient Global Assessment(Baseline and Month 12)
- Percent Change From Baseline to Month 12 in Body Surface Area Affected by Psoriasis(Baseline and Month 12)
- Percent Change From Baseline to Month 12 in the Dermatology Life Quality Index Total Score(Baseline and Month 12)
研究者
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