NCT00525616已完成3 期
Assessment of Rituximab Efficiency and Tolerance in Treatment of Bullous Pemphigoid.
University Hospital, Rouen2 个研究点 分布在 1 个国家目标入组 18 人开始时间: 2008年12月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 18
- 试验地点
- 2
- 主要终点
- Clinical and biological controls of bullous pemphigoid were estimated every seven days during a period of 1 month and every month during a period of 2 years.
研究概览
简要总结
The aim of the study is to assess that it will be possible to control with a single cycle of rituximab patient with bullous pemphigoid.
详细描述
The objective of this study is to assess the efficacy and tolerance of a single cycle of rituximab in control of bullous pemphigoid.
the main objects are :
- to assess that a single cycle of rituximab is able to control patient with corticosteroid-dependent bullous pemphigoid,
- to avoid the use of corticosteroid in long time,
- to evaluate duration of control disease and side effect with a single cycle of rituximab.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >= 18 and < 80
- •karnofsky >= 50%
- •bullous pemphigoid clinical indication
- •cortico-dependent bullous pemphigoid in relapse for the second time
- •contraception used in female patient
- •consent obtained from patient
排除标准
- •localized bullous pemphigoid in relapse (<400cm2)
- •pemphigoid of pregnancy
- •dermatosis with IgA
- •pemphigoid with mucous damage
- •pregnant woman or nursing mother
- •woman able to have a baby and without contraception during the clinical trial period
- •age < 18 or > 80
- •karnovsky < 50%
- •significant disease or uncontrolled disease
- •serious antecedents of allergy or anaphylactic reaction with human monoclonal antibody
- •patient with depletion lymphocytic treatment or with initial rituximab treatment
- •unstable angina or ischemic heart disease
- •cardiac insufficiency
- •cardiac rhythm trouble uncontrolled
- •evolutive infection
- •immunodepression
- •neutrophil polynuclear in blood < 1.5 G/l and /or platelet blood concentration < 75G/l
- •positive HIV serology
- •positive hepatitis B and / or C serology
- •concomitant immunodepressor treatment able to induce depletion lymphocytic treatment
- •no consentment
- •antecedent of serious chronic or recurrent infection or other underlying pathology able to induce serious infection
- •antecedent of deep tissue infection occurred the previous year of inclusion
研究组 & 干预措施
Rituximab
Experimental
Treatment consists of two slow intravenous infusions of rituximab 1000mg to 15 days apart with local corticosteroid .
干预措施: Mabthera (Drug)
结局指标
主要结局
Clinical and biological controls of bullous pemphigoid were estimated every seven days during a period of 1 month and every month during a period of 2 years.
时间窗: 2 years
次要结局
- Adverse reactions will be estimated during all the period of this clinical trial(3 years)
研究者
研究点 (2)
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