EUCTR2008-007492-24-NL进行中（未招募）不适用
An independent prospective randomised controlled trial comparing the efficacy and cost effectiveness of infliximab and etanercept in 'high need' patients with moderate to severe chronic plaque type psoriasis - PIECE
Academic Medical Center0 个研究点目标入组 120 人开始时间: 2009年1月27日最近更新:
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Adults patients (18-75 years of age)
- •- Psoriasis Area and Severity Index (PASI > 10) and/or Body Surface Area (BSA) > 10.
- •- Failed, contraindicated and/or intolerant to UV therapy, methotrexate or cyclosporin.
- •- Informed consent
- •- Able to complete Dutch questionnaires.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •- Pregnancy and lactation
- •- Active (or chronic) infections including Hepatitis B and C viral infections, HIV and tuberculosis
- •- Malignancy in last 10 years, except BCC and cervical in situ cancer
- •- Demyelinating disease
- •- Congestive heart failure (NYHA grade III or IV)
- •- Allergic and hypersensitivity reactions to study drugs or ingredients
- •- Any live virus or bacterial vaccination within 3 months
- •- Severe liverfunction disorders >2 times and/or kidneyfunction disorders >1,5 times upper limits of the parameters.
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