NCT00707070Unknown4 期
Phase IV Study on Efficacy and Safety of the Combination Treatment Acitretin and Efalizumab in Moderate to Severe Chronic Plaque Psoriasis
Universita di Verona1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2008年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- PASI 75 and PASI 50 at week 24 Physician Global Assessment
研究概览
简要总结
It is a phase IV multicentric, placebo-controlled, clinical trial investigating the efficacy and safety of acitretin combined to efalizumab in the therapy of chronic plaque psoriasis. PASI 75 at week 24 will be the primary end point. PASI 75 at week 12, and PASI 50 at week 24 will be the secondary end points. Safety measures will be the monitoring of serum parameters including AST; ALT; gammaGT; creatinine; cholesterol and triglycerides.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Men aged 18-70
- •Women in postmenopausal
- •Moderate to severe chronic plaque psoriasis in patients with contraindication, intolerance or non responsive to cyclosporine, methotrexate or PUVA
- •PASI > 10 e/o BSA (Body Surface Area) > 10
排除标准
- •Drug induced psoriasis
- •Pustular or erythrodermic psoriasis
- •Fertile women
- •Pregnancy or lactation
- •cholesterol > 230mg/dL e triglyceride > 200 mg/dL
- •Known intolerance to efalizumab and acitretin
- •Serious infection at enrollement
- •History of previous neoplasia
研究组 & 干预措施
1
Experimental
efalizumab 1 mg/kg/week subcutaneous plus acitretin 0.4 mg/kg/day oral
干预措施: efalizumab plus acitretin (Drug)
2
Placebo Comparator
efalizumab 1 mg/Kg/week subcutaneous plus oral placebo
干预措施: efalizumab plus placebo (Drug)
结局指标
主要结局
PASI 75 and PASI 50 at week 24 Physician Global Assessment
时间窗: week 12 and 24
次要结局
- SKINDEX 29 at week 24 and AST, ALT, cholesterol, triglycerides at week 12 and week 24(week 24)
研究者
研究点 (1)
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