EUCTR2004-004201-18-SE进行中（未招募）不适用
A multicenter, open-label, randomized, pilot study to evaluate the efficacy and safety of the combination of etanercept (ETN) and methotrexate and of etanercept (ETN) alone in patients with active plaque psoriasis despite methotrexate therapy
Wyeth Lederle Nordiska AB0 个研究点目标入组 60 人开始时间: 2004年12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
- 60
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. Active plaque psoriasis involving =10% of the body surface area (BSA) and/or a minimal screening PASI score of 8.
- •2. MTX at a dose of minimum 7.5 mg/week for the last 3 months.
- •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. Predominantly guttate, erythrodermic, or pustular psoriasis.
- •2. Clear or almost clear on PGA (Phycians Global Assessment).
- •3. Previous receipt of any TNF-inhibitor, including etanercept.
- •4. Skin conditions (e.g. eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis.
- •6. Psoralen plus ultraviolet A radiation (PUVA), cyclosporine, acitretin, alefacept (Amevive) and efalizumab (Raptiva) or any other systemic psoriasis therapy (exception: methotrexate) within 4 weeks of study drug initiation.
- •7. Systemic corticosteroids within 4 weeks prior to study drug initiation.
- •8. Ultraviolet light B (UVB), topical steroids group III and IV, topical Vitamin A or D analog preparations, or anthralin within 2 weeks prior to study drug initiation.
- •9. Tar compounds (except tar shampoo) within 4 weeks prior to study drug initiation.
- •10. Significant concurrent medical diseases including:
- •· Diabetes mellitus requiring insulin
- •· Uncompensated congestive heart failure
- •· Myocardial infarction within 12 months of screening visit
- •· Unstable angina pectoris
- •· Uncontrolled hypertension
- •· Severe pulmonary disease
- •· Patients with systemic lupus erythematosus or history of multiple sclerosis or any other demyelinating disease
- •· History of cancer (other than resected cutaneous basal and squamos cell carcinoma, and in situ cervical cancer) within 5 years of baseline visit
- •· Known HIV positive, hepatis BsAg, or hepatitis C positive
- •· Any condition judged by the patient’s physician that would cause this study to be detrimental to the patient.
研究者
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