In Vivo Induction of T Cell Apoptosis by Alefacept (LFA-3/IgG1 Fusion Protein, Amevive) in Patients With Psoriasis: An Investigator-Initiated, Open-Label, Mechanism of Action Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 2
- 主要终点
- To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo
研究概览
简要总结
To determine the mechanism of action of alefacept in patients with psoriasis.
详细描述
The purpose of the study is to better understand the mechanism of action of an FDA approved drug (alefacept). Subjects enrolled will be given alefacept 7.5 mg intravenously on a weekly basis for 12 weeks. Response is assessed by improvement in the PASI score. The responders will get no further treatment and the nonresponders will receive additional 4 weeks of therapy. Skin biopsies will be obtained throughout the study and T-cell apoptosis will be correlated to clinical response. There is no placebo group. The duration of the study is approximately 1 year.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Alefacept is indicated for the treatment of adult patients (18 years or older) with moderate to severe chronic plaque psoriasis who are candidates for systemic therapy or phototherapy. Patients must have at least one plaque of least 2.5 cm in diameter (for biopsies).
排除标准
- •CD4 < 400/ml
- •WBC less than lower level of normal for the reporting laboratory
- •< 5% Body Surface Area involved with psoriasis
- •Serious infection e.g., latent or active tuberculosis
- •History of AIDS or Hepatitis B,C, all internal cancers, lymphoma, untreated cutaneous basal or squamous cell carcinoma
- •Systemic anti-psoriasis medications and phototherapy within 28 days of the first dose of Alefacept
- •Topical anti-psoriasis medications within 14 days of the first dose of Alefacept, except for moisturizers, tar shampoos (exception, Elidel is permitted to be applied on the face, groin and axillae areas. These areas are not biopsied.)
- •Inability to understand consent form or comply with study requirements
- •Pregnancy or lactation
- •Concurrent medical illness that would make participation in this clinical trial ill-advised
- •Any contraindications to using alefacept
结局指标
主要结局
To determine if alefacept induces apoptosis in circulating T cells and plaque T cells in psoriasis patients in vivo
次要结局
- To determine if apoptosis of circulating or plaque T cells in vivo is a better predictor of clinical response than are circulating CD4 T cell counts.