NCT01338103Unknown不适用
Treatment of Moderate to Severe Patients With Pemphigus With the Monoclonal Anti CD20 Antibody Rituximab at a Protocol of 1000mgX2 and Assessment of Their Immune Status Via the Cylex Test
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Complete or partial remission off treatment (based on the consensus statement for pemphigus)
研究概览
简要总结
The purpose of this study is to determine whether Rituximab, in the same doses as used in rheumatoid arthritis patients, will benefit pemphigus patients. It also tests immune function via the Cylex assay in pemphigus patients before and after treatment with RItuximab.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Pemphigus patients with moderate-severe disease
排除标准
- •Pregnancy or lactation
- •Woman of reproductive age not using birth control measures.
- •Prior severe allergy or anaphylaxis with a human monoclonal antibody
- •Heart failure
- •Unstable angina or ischemic heart disease
- •Uncontrolled arrhythmia
- •HIV positive
- •Active hepatitis B infection or positive for hepatitis C virus (HCV) antibodies.
- •Severe dementia or a psychiatric illness
- •Active acute infection
研究组 & 干预措施
Rituximab
Experimental
干预措施: Rituximab (Drug)
结局指标
主要结局
Complete or partial remission off treatment (based on the consensus statement for pemphigus)
时间窗: 6 months after treatment
次要结局
未报告次要终点
研究者
研究点 (1)
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