EUCTR2007-001630-14-NL进行中(未招募)1 期
Safety and efficacy of efalizumab in combination with methotrexate in patients with severe psoriasis: a comparative study.
niversity Medical Centre St. Radboud, Department of Dermatology0 个研究点目标入组 30 人开始时间: 2007年8月7日最近更新:
适应症
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 30
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
- •1. Patients must be ³ 18 years of age.
- •2. Patients must have a diagnosis of moderate to severe chronic plaque psoriasis.
- •3. Patients must have a PASI ³ 10, or a PASI ³ 8 in combination with a Skindex-29 16 > 35.
- •4. Patients must have failed to respond to phototherapy, methotrexate and/or cyclosporin in the past or have a contraindication for using phototherapy or cyclosporin.
- •5. Patients must be free of any clinically significant disease (other than psoriasis) that would interfere with the study evaluations.
- •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
- •1. Patients who have non-plaque forms of psoriasis as the dominant form of psoriasis (e.g., erythrodermic, guttate or pustular).
- •2. Patients who have current drug-induced psoriasis.
- •3. Female patients who are pregnant, nursing and both men and women who are planning pregnancy during the study period or during the six months after receiving the last dose of study medication.
- •4. Patients who have current signs or symptoms of severe, progressive or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological, cerebral, or psychiatric disease.
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