NL-OMON35488尚未招募4 期
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 - Independent RCT comparing infliximab and enbrel in psoriasis. PIECE study
适应症
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 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
入排标准
- 年龄范围
- 18 至 99（—）
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, and/or PASI* 8 together with skindex * 35.
- •- Failed, contraindicated and/or intolerant to UV therapy, en methotrexate or cyclosporin.
- •- Informed consent
- •- Able to complete Dutch questionnaires.
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
- •- 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 kidney function disorders >1,5 times upper limits of the parameters.
- •-Treatment of infliximab or etanercept stopped because of inefficacy, contraindication or serious adverse events, after infliximab therapy for minimal 3 infusions and an evaluation after 12 weeks, or etanercept therapy for minimal 12 weeks
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