An Open-Label Study to Evaluate Whether a Short-Term Course of Methotrexate in Psoriasis Patients Treated With Efalizumab is Safe and Increases Efficacy
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- PASI -- Psoriasis Area and Severity Index
研究概览
简要总结
To evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.
详细描述
The primary objective of this study is to evaluate whether a short-term course of methotrexate in patients treated with efalizumab (Raptiva) increases efficacy. The secondary objectives of this study are 1) to evaluate the efficacy of Raptiva in maintaining the clinical improvement induced by short-term treatment with combination therapy of Raptiva and methotrexate 2) to evaluate the safety of short-term combination therapy of Raptiva and methotrexate.
The design of this study is to gain better control of the disease process while reducing potential toxicities by beginning treatment with Raptiva and adding methotrexate to those patients who do not improve significantly
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 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
- 是
入选标准
- •Moderate to severe plaque-type psoriasis
- •A candidate for systemic therapy or phototherapy
- •Not using prescription systemic therapies for psoriasis prior to starting the study
- •Not using efalizumab within 3 months prior to starting the study
- •We are seeking adults who:
- •Have moderate to severe plaque-type psoriasis
- •Are generally healthy
- •Are not hypersensitive to Raptiva® (efalizumab) or any of its components.
- •Are not pregnant or lactating women
- •Be interviewed and examined
- •Have blood drawn
- •Be injecting the study medication
排除标准
- •Hypersensitivity to Raptiva or any of its components
- •Pregnant or lactating women
- •History of liver disease or abnormal liver enzymes
- •History of chronic infection or malignancy
- •History of significant hematologic abnormalities
研究组 & 干预措施
A
Monotherapy with Raptiva alone
干预措施: Raptiva (Drug)
B
Combination therapy with both Raptiva and Methotrexate
干预措施: Methotrexate (Drug)
B
Combination therapy with both Raptiva and Methotrexate
干预措施: Raptiva (Drug)
C
Continue Raptiva, discontinue methotrexate
干预措施: Raptiva (Drug)
D
Continue combination therapy with both Raptiva and Methotrexate
干预措施: Methotrexate (Drug)
D
Continue combination therapy with both Raptiva and Methotrexate
干预措施: Raptiva (Drug)
结局指标
主要结局
PASI -- Psoriasis Area and Severity Index
时间窗: 16 vs. 36 weeks, depending on study arm
(PASI) - given by numerical score, the index shows the severity of psoriasis.
次要结局
- Adverse Events (AE)(16 vs. 36 weeks, depending on study arm)