NCT00307593已完成不适用
Infliximab Versus Rituximab in Systemic Necrotizing Vasculitides With Positive ANCA After Relapse or Resistant Immunosuppressant Therapies
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Partial or complete remission of the vasculitides
研究概览
简要总结
The purpose of this study is to compare a 2 immunosuppressant regimen for the treatment of relapsing or refractory necrotizing antineutrophil cytoplasmic antibody (ANCA) associated vasculitides.
详细描述
The aim of this study is to compare the efficacy of rituximab versus infliximab in relapsing or refractory forms of ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 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
- •Systemic ANCA positive (+) vasculitides
- •Relapsing or refractory vasculitides, resistant to corticosteroids and reference immunosuppressant therapies
- •Age >18 years old
- •Written informed consent
排除标准
- •Newly diagnosed patient
- •Patient that had never received an immunosuppressant before to treat his/her vasculitis
- •Malignancy
- •Pregnancy
研究组 & 干预措施
1
Active Comparator
Rituximab
干预措施: Rituximab (Drug)
2
Active Comparator
Infliximab
干预措施: Infliximab (Drug)
结局指标
主要结局
Partial or complete remission of the vasculitides
时间窗: one year
次要结局
- To study the safety and adverse effects of both regimens(one year)
- Microscopic polyangiitis(one year)
- Wegener's granulomatosis(one year)
- Churg-Strauss syndrome(one year)
研究者
研究点 (1)
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