EUCTR2004-002629-36-DK进行中（未招募）1 期
A Randomized, Open Label Study to Evaluate the Safety and Efficacy of Etanercept in the Treatment of Subjects with Psoriasis - CLEAREST
Wyeth Pharmaceuticals, Global Medical Affairs Department0 个研究点目标入组 720 人开始时间: 2005年1月25日最近更新:
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 720
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. 18 years of age or older at Screening Visit.
- •2. Stable, active plaque psoriasis involving = 10% of body surface area (BSA) and PGA status of moderate or worse at screening and baseline.
- •3. Failure to respond to one of the following systemic therapies at an adequate dose of sufficient duration, or have a contraindication to, or intolerant to:
- •Methotrexate
- •Cyclosporine
- •Fumarate (only in countries where it is approved for psoriasis)
- •4. Negative serum pregnancy test at screening and urine pregnancy test at baseline 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 of 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 2o C to 8o 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
- •1. Any grade 3 or 4 adverse event or infection (see Attachment 6) 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 psoriasis therapy within 28 days prior to study drug initiation (Exception: stable doses of methotrexate and acitretin continued throughout the study). See Section 15.2 Prohibited Treatment for a partial 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. Oral or injectable corticosteroids within 28 days prior to study drug initiation
- •6. Prior exposure to any TNF-inhibitor, including ETN
- •7. Receipt of any investigational or biologic drugs within 28 days prior to Screening Visit
- •8. Receipt of any live (attenuated) vaccines within 28 days prior to Screening Visit
- •9. Severe comorbidities (including but not limited to 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 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)
- •10. Known untreated tuberculosis (TB) infection (Note: investigators should review local country guidelines for any TB screening test requirements)
- •11. Known history of human immunodeficiency (HIV) infection
- •12. Concurrent or history of psychiatric disease that would interfere with ability to comply with study protocol or give informed consent
- •13. History of alcohol or drug abuse within 12 months prior to Screening Visit
- •14. Currently breast-feeding
- •15. Contraindication or hypersensitivity to etanercept
研究者
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