NCT00735787已完成4 期
Controlled Study of Humira in Subjects With Chronic Plaque Psoriasis of the Hands and/or Feet
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Abbott
- 入组人数
- 81
- 试验地点
- 34
- 主要终点
- Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16
研究概览
简要总结
Evaluate the efficacy and safety of a 16-week course of Humira (adalimumab) compared to placebo in adults with chronic plaque psoriasis of the hands and/or feet and the sustainability of response for 12 additional weeks.
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
- Double (Participant, Investigator)
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
- •Adult with Diagnosis of chronic plaque psoriasis of the Hands and Feet for at least 6 months, with a PGA >/=3 and candidates for systemic therapy;
- •Patients in good general health
- •Able to self-administer injections
- •Negative chest x-ray (CXR) and purified protein derivative (PPD) test, unless willing to start anti-tuberculosis (TB) prophylaxis
排除标准
- •Previous treatment with HUMIRA®
- •Required mediation stability or washouts for: systemic corticosteroids (28 days), other investigational agent, other systemic therapies for psoriasis, ultraviolet B (UVB), psoralen with UVA (PUVA)
- •Other active skin diseases or skin infections
- •Diagnosis of palmoplantar pustulosis; erythrodermic psoriasis, pustular psoriasis, medication-induced or exacerbated psoriasis or new onset of guttate psoriasis
- •Evidence of dysplasia or history of malignancy (Other than a successfully treated non-metastatic cutaneous squamous cell, basal cell carcinoma or localized carcinoma in situ of the cervix);
- •History of listeriosis, histoplasmosis, chronic or active Hepatitis B infection, human immunodeficiency virus (HIV) infection, immunodeficiency syndrome, chronic recurring infections or active tuberculosis (TB);
- •History of moderate to severe congestive heart failure,
- •Recent cerebrovascular accident and any other condition which, in the opinion of the investigator, would put the subject at risk;
- •History of central nervous system (CNS) demyelinating disease or neurologic symptoms suggestive of CNS demyelinating disease;
- •History of clinically significant drug or alcohol abuse in the last 12 months;
- •Infection(s) requiring treatment with intravenous (IV) antibiotics, IV antivirals, or IV antifungals within 30 days prior to Baseline or oral antibiotics, oral antivirals, or oral antifungals within 14 days prior to Baseline;
- •Known hypersensitivity to the excipients of HUMIRA® as stated in the label;
- •Female subjects who are pregnant or breast-feeding or considering becoming pregnant during the study.
- •Prior exposure to Tysabri® (natalizumab)
结局指标
主要结局
Number of Subjects With Physician's Global Assessment of Psoriasis (PGA) of Clear or Almost Clear at Week 16
时间窗: Week 16
Number of subjects achieving a PGA of clear (representing no signs of plaque psoriasis) or almost clear (representing just perceptible erythema and scaling) at Week 16. The PGA is a 5-point scale used to measure the severity of disease at the time of the physician's evaluation of the subject. The degree of overall severity is rated as follows: 0-Clear, 1-Almost clear, 2-Mild, 3-Moderate, and 4-Severe.
次要结局
- Mean Change From Baseline in Erythema, Scaling, Induration, and Fissuring (ESIF)(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28)
- Mean Change From Baseline in ESIF for Palms(Baseline and Weeks 2, 4, 12, 16, 20, 24, and 28)
- Mean Change From Baseline in ESIF for Soles(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28)
- Number of Subjects With Moderate Improvement in ESIF From Baseline(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28)
- Number of Subjects With Marked Improvement in ESIF From Baseline(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, 28)
- Mean Change From Baseline in Nail Psoriasis Severity Index (NAPSI)(Baseline and Weeks 8, 16, and 28)
- Number of Subjects With Physicians Global Assessment of Psoriasis (PGA) of Clear, Almost Clear, or Mild(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28)
- Number of Subjects With PGA of Clear or Almost Clear(Baseline and Weeks 2, 4, 8, 12, 20, 24, and 28)
- Number of Subjects With PGA of Clear(Baseline and Weeks 2, 4, 8, 12, 16, 20, 24, and 28)
- Number of Subjects With Psoriasis Area and Severity Index (PASI) 50(Baseline and Weeks 16 and 28)
- Number of Subjects With PASI 75(Baseline and Weeks 16 and 28)
- Number of Subjects With PASI 90(Baseline and Weeks 16 and 28)
- Number of Subjects With PASI 100(Baseline and Weeks 16 and 28)
- Mean Change From Baseline in Dermatology Life Quality Index (DLQI)(Baseline and Weeks 2, 8, 16, and 28)
- Number of Subjects Achieving a DLQI of 0(Baseline and Weeks 2, 8, 16, and 28)
- Mean Change From Baseline in Visual Analog Scale (VAS) for Psoriasis and Psoriatic Arthritis Pain(Baseline and Weeks 16 and 28)
- Mean Change From Baseline in Work Productivity and Activity Impairment Questionnaire: Psoriasis (WPAI:PSO)(Baseline and Weeks 8, 16, and 28)
- Mean Change From Baseline in Patient Health Questionnaire (PHQ-9)(Baseline and Weeks 2, 8, 16, and 28)
- Number of Subjects With Difficulties According to PHQ-9(Baseline and Weeks 2, 8, 16, and 28)
研究者
研究点 (34)
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