NCT00184366终止不适用
Classification and Characterization of Patients Suffering From Moderate to Severe Plaque Psoriasis Responding to Subcutaneous Administered Efalizumab
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 96
- 试验地点
- 1
- 主要终点
- Response PASI 75
研究概览
简要总结
The main objectives of the project are:
- To classify patients suffering from plaque psoriasis responding on a given treatment (efalizumab) based upon reduction in Psoriasis Area and severity Index (PASI), Psoriasis Disability Index 8PDI) and dermatology Life Quality Index 8 DLQI)
- To characterize patients suffering from plaque psoriasis responding to or not responding to subcutaneous administrated efalizumab.
详细描述
This is an investigator initiated,prospective, longitudinal, observation study. Before starting treatment with efalizumab we will record factors such as demographic data, type of psoriasis, previous treatment, other diseases etc.
We will follow the patients and classify them as responders and non-responders. We hope to find 4-5 factors which we can use later to predict response of this drug.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
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
- •moderate to severe plaque psoriasis for more than six months
- •eligible for efalizumab treatment according to current Norwegian guidelines
排除标准
- •Pregnant or breast-feeding patients
- •Patients with a history of uncontrolled bacterial, viral, fungal or atypical mycobacterial infection.
- •Patients suffering from HIV, Hepatitis B or C, active tuberculosis, hepatic cirrhosis and hospital admission for cardiac disease, stroke or pulmonary disease within last year.
- •Patients with history of cancer in the preceding 5 years, including lymphoproliferative disorders. patients with history of fully resolved basal cell or squamous cell skin cancer may be enrolled.
- •Patients with impaired renal or hepatic function.
结局指标
主要结局
Response PASI 75
时间窗: 2 years
次要结局
- Dermatology Life Quality index (DLQI)(2 years)
- Psoriasis disability Index (PDI)(2 years)
研究者
研究点 (1)
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