EUCTR2004-002629-36-CZ进行中（未招募）不适用
A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects with Psoriasis
Wyeth Pharmaceuticals, Global Medical Affairs Department0 个研究点目标入组 700 人开始时间: 2005年2月8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
- 700
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
- •Subject must fulfill all of the following conditions or characteristics in order to be considered for study enrollment or participation:
- •1. 18 years of age or older at Screening Visit
- •2. Stable, active plaque psoriasis involving =10% of body surface area and PGA status of moderate” or worse at screening and baseline
- •3. Failure to respond to, or have a contraindication to, or intolerant to one of the following systemic therapies:
- •· Methotrexate
- •· Cyclosporine
- •· Fumarate (only in countries where it is approved for psoriasis)
- •4. Negative urine pregnancy test within seven days before the first dose of study drug in all women (except those surgically sterile or at least three years postmenopausal). Sexually active women of childbearing potential participating in the study must use a medically acceptable form of contraception, which include oral contraception, injectable or implantable methods, intrauterine devices, or properly used barrier contraception. A woman of childbearing potential is defined as 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.
- •5. Capable of understanding and signing informed consent
- •6. Able to store injectable test article at 2° C to 8° C
- •7. Able and willing to self-inject test article or have a designee who can do so
- •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
- •Subjects with any of the following conditions or characteristics will be excluded from study enrollment:
- •1. Any grade 3 or 4 adverse event or infection (see Attachment 5) within 28 days prior to screening, or between the Screening Visit and study drug initiation
- •2. Evidence of skin conditions (eg, eczema) other than psoriasis that would interfere with evaluations of the effect of study medication on psoriasis
- •3. Psoralen plus ultraviolet A radiation (PUVA), cyclosporine, alefacept (Amevive®), efalizumab (Raptiva®), or any other systemic anti-psoriasis therapy within 28 days prior to study drug initiation (Exception: methotrexate and acitretin). See Section 15.2 (Prohibited Treatment) for a listing of prohibited systemic therapies.
- •4. Ultraviolet light B (UVB) therapy, topical steroids, topical Vitamin A or D analog preparations, or anthralin within 14 days prior to study drug initiation (exception: topical steroids at no higher than moderate strength, are permitted on scalp, axillae, and groin but dose and formulation must remain stable through Week 54)
- •5. Prior exposure to any TNF-inhibitor, including ETN
- •6. Receipt of any investigational or biologic drugs within 28 days prior to Screening Visit
- •7. Receipt of any live (attenuated) vaccines within 28 days prior to Screening Visit
- •8. Severe comorbidities (diabetes mellitus requiring insulin, uncompensated congestive heart failure [CHF], history of myocardial infarction [MI], unstable angina pectoris, uncontrolled hypertension, severe pulmonary disease [requiring oxygen therapy], history of cancer within 5 years [other than resected cutaneous basal and squamous cell carcinoma and in situ cervical cancer], hepatitis B surface antigen [hepatitis BsAg] or hepatitis C, systemic lupus erythematosus, or history of multiple sclerosis or any other demyelinating disease)
- •9. Known history of tuberculosis (TB) or previous positive TB screening test (Note: if required by local country guidelines, subject must demonstrates a negative TB screening test)
- •10. Known history of human immunodeficiency (HIV) infection
- •11. Concurrent or history of psychiatric disease that would interfere with ability to comply with study protocol or give informed consent
- •12. History of alcohol or drug abuse within 12 months prior to Screening Visit
- •13. Currently breast feeding
研究者
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