A Randomized Study to Evaluate the Efficacy and Safety of Adding Topical Therapy to Etanercept in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 592
- 主要终点
- PASI 75 at Week 12
研究概览
简要总结
The primary hypothesis of this trial is that the addition of short courses of clobetasol propionate foam to etanercept monotherapy in subjects with moderate to severe plaque psoriasis will yield greater efficacy compared with etanercept monotherapy, as measured by PASI 75 at Week 12.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has had stable moderate to severe plaque psoriasis for at least 6 months
- •Subject has involved BSA ≥ 10% and PASI ≥ 10 at screening and at baseline.
- •Subject is a candidate for systemic therapy or phototherapy in the opinion of the investigator
排除标准
- •Subject has active guttate, erythrodermic, or pustular psoriasis at the time of the screening visit.
- •Subject has evidence of skin conditions at the time of the screening visit (eg, eczema) that would interfere with evaluations of the effect of etanercept and/orclobetasol propionate foam on psoriasis.
- •Subject diagnosed with medication-induced or medication exacerbated psoriasis
- •Subject has any active Common Toxicity Criteria (CTC) grade 2 or higher infection
- •Subject has a significant concurrent medical condition or laboratory abnormalities as defined in the study protocol.
- •Subject has used any of the following therapies within 14 days of the first dose: UVB therapy or topical psoriasis therapies other than Class I or II topical steroids.
- •Subject has used any of the following therapies within 28 days of the first dose: Class I or II topical steriods, UVA therapy (with or without psoralen), or systemic psoriasis therapies
- •Subject has used one or more biologic therapies (other than interleukin (IL)12/IL23 inhibitors) within 3 months of the first dose
- •Subject has used an IL-12/IL-23 inhibitor within 6 months of the first dose of etanercept
- •Subject has ever used efalizumab (Raptiva®).
研究组 & 干预措施
etanercept and clobetasol
Etanercept 50 mg twice weekly x 12 weeks + clobetasol propionate foam (weeks 11 and 12) then Etanercept 50 mg once weekly x 12 weeks + clobetasol propionate foam (weeks 23 and 24)
干预措施: 2=Clobetasol propionate foam (Drug)
etanercept
Etanercept 50 mg twice weekly x 12 weeks then Etanercept 50 mg once weekly x 12 weeks
干预措施: 1=Etanercept (Drug)
结局指标
主要结局
PASI 75 at Week 12
时间窗: Week 12
The percentage of participants with the Psoriasis Area and Severity Indexs (PASI) 75 responses at week 12. PASI is an assessment of psoriasis based on severity of erythema, infiltration, and desquamation as well as area of involvement. The PASI score ranges from 0 to 72. The higher score represents the worse symptom severity. A response was considered a 75% reduction in the PASI score from Baseline.
次要结局
- sPGA (0,1) at Week 12(Week 12)
- sPGA (0,1) at Week 24(Week 24)
- Patient Satisfaction at Week 12(Week 12)
- PASI 90 at Week 12(Week 12)
- Percent PASI Improvement From Baseline at Week 12(Week 12)
- PASI 75 at Week 24(Week 24)