EUCTR2005-005936-29-IT进行中（未招募）不适用
A Multicenter, Parallel, Randomized, Double-Blind, Placebo-Controlled Trial Evaluating the Safety and Efficacy of Etanercept 50 mg Once Weekly in Subjects With Moderate to Severe Plaque Psoriasis - ND
Wyeth Research Division of Wyeth Pharmaceuticals Inc. Clinical Research and Development0 个研究点目标入组 120 人开始时间: 2007年7月19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
- •1.Adults ³ 18 years of age with clinically stable plaque psoriasis involving ³ 10% ofthe body surface and a minimum Psoriasis Area and Severity Index (PASI) score of 10 at screening.
- •2.Failure to respond to, or have a contraindication to, or intolerant to at least 1 of the following systemic or phototherapies at an adequate dose of sufficient duration:
- •·Methotrexate (MTX)
- •·Cyclosporine
- •·Ultraviolet A (UVA)
- •·Ultraviolet B (UVB)
- •·Psoralen and ultraviolet A (PUVA)·Fumarate
- •3.Negative result of serum ß-human chorionic gonadotropin (ß-HCG) pregnancy test taken at screening or baseline for all women, except those who are surgically sterile or at least 1 year postmenopausal. 4.Sexually active women of childbearing potential and sexually active men participating in the study must use a medically acceptable form of contraception. A woman of childbearing potential is one who is biologically capable of becoming pregnant. This includes women who are using contraceptives or whose sexual partners are either sterile or using contraceptives. Medically acceptable forms of contraception include oral contraceptives, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. Additionally, the use of condoms is suggested as an adjunct to the methods previously addressed to protect against sexually transmitted diseases and to provide additional protection against accidental pregnancy. 5.Subject or designee must have the ability to reconstitute and inject test article subcutaneously. 6.Subject is capable of understanding and giving written, voluntary informed consent before study screening. 7.Ability to store injectable test article at 2°C to 8°C.
- •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.Previous treatment with etanercept, antibody to TNFa, or other TNFa inhibitors. 2.Active guttate, erythrodermic, or pustular psoriasis at the time of the screening or baseline visit. 3.Serious infection (requiring parenteral antibiotic and/or hospitalization) within one month prior to screening or baseline visit.
- •4.Abnormality in hematology or chemistry profiles at screening or baseline visit: alanine transaminase (ALT) and aspartate transaminase (AST) > 2 x the upper limit of normal: hemoglobin < 85 g/L (8.5 g/dL); platelet count < 125 x109/L (125,000 cells/mm3); white blood cell count < 3.5 x109/L (3,500 cells/mm3); serum creatinine > 177 µmol/L (2 mg/dL).
- •5.Evidence of skin conditions at the time of the screening or baseline visit (eg, eczema) that would interfere with evaluations of the effect of test article on psoriasis. 6.Receipt of any investigational drug(s) within 3 months of baseline visit. 7.Receipt of any live (attenuated) vaccine within one month prior to baseline visit.
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