NCT00791765已完成4 期
A Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Etanercept in Treating Scalp Involvement in Subjects With Moderate to Severe Plaque Psoriasis
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 124
- 主要终点
- Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12
研究概览
简要总结
The purpose of this study is to determine if etanercept is effective in the treatment of scalp involvement in moderate to severe plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Must provide written informed consent before any study-specific procedure
- •Be male or female greater than or equal to 18 years of age at time of screening
- •Has stable moderate to severe plaque psoriasis for at least 6 months
- •Affected body surface area (BSA) greater than or equal to 10%
- •Psoriasis Area and Severity Index (PASI) score greater than or equal to 10
- •At least 30 percent affected scalp surface area
- •Psoriasis Scalp Severity Index (PSSI) score greater than or equal to 15
- •Candidate for systemic therapy or phototherapy in the opinion of the investigator
- •Negative test for hepatitis B surface antigen, hepatitis C antibody, and Human Immunodeficiency Virus (HIV)
- •Negative serum pregnancy test for female subjects (unless 3 years post menopausal or surgically sterile)
- •Willing to use medically acceptable form of birth control for duration of study
- •Negative Purified Protein Derivative (PPD) within 30 days prior to first dose of study drug
排除标准
- •Any active infection
- •Significant concurrent medical conditions, including: Insulin dependent diabetes mellitus; Congestive heart failure; Myocardial infarction within last year; Unstable angina pectoris; Uncontrolled hypertension; Severe pulmonary disease [requiring oxygen therapy or hospitalization]; Systemic lupus erythematosus; Multiple sclerosis or any other demyelinating disease; Active malignancy
- •Any condition, in opinion of study doctor, that might cause this study to be detrimental to subject
- •History of cancer within 5 years before first dose of study drug
- •Skin conditions other than psoriasis that would interfere with evaluations of the effect of study medications on psoriasis
- •Presence of guttate, erythrodermic or pustular psoriasis
- •Use of topical cyclosporine or calcineurin inhibitors within 14 days of first dose of study drug
- •Use of tar shampoos within 14 days of first dose of study drug
- •Use of following therapies within 28 days of first dose of study drug: IV or oral cyclosporine or calcineurin inhibitors, Ultraviolet Light A therapy, Psoralen plus ultraviolet A radiation, Oral retinoids, Ultraviolet Light B therapy, Topical steroids or steroid shampoo, Topical vitamin A or D analog preparations, Anthralin, other systemic psoriasis therapy, cyclophosphamide, sulfasalazine, anakinra
- •Use of Alefacept (Amevive), Efalizumab (Raptiva), Anti-tumor necrosis factor (TNF) biologic therapies within 3 months of the first dose of study drug. Prior anti-TNF use will not be permitted if discontinued due to lack of efficacy, an adverse event, or non-compliance.
- •Use of interleukin (IL)-12/IL-23 within 6 months of the first dose of study drug
- •Participation in another clinical trial within 90 days or 5 half-lives (whichever is longer) of randomization
- •Laboratory abnormalities at screening: hemoglobin less than 11 g/dL, platelet count less than 125,000/mm^3, white blood cell count less than 3,500 cells/mm^3, aspartate aminotransferase (AST)/alanine aminotransferase (ALT) greater than or equal to 1.5 x the upper limit of normal, any other laboratory abnormality which will prevent patient from completing the study or interfere with interpretation of study results
- •Patient is pregnant or breast feeding
- •Presence of any condition that could compromise the patient's ability to participate in the study, such as a history of substance abuse or psychiatric condition
结局指标
主要结局
Percentage Change From Baseline in Psoriasis Scalp Severity Index at Week 12
时间窗: Baseline and Week 12
The Psoriasis Scalp Severity Index (PSSI) measures the extent of psoriasis involvement and the severity of erythema, infiltration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored by physicians using a scale from 0 to 72, where 0 = no psoriasis, and higher scores indicating more severe disease. The PSSI calculation does not include the face or neck area.
次要结局
- Percentage of Participants With PSSI 75% Response at Week 12(Baseline and Week 12)
- Patient Satisfaction With Treatment at Week 12(12 Weeks)
- Percent Change From Baseline in PSSI at Week 24 in Participants Switching From Placebo to Etanercept at Week 12(Baseline and Week 24)
研究者
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