NCT01586858终止不适用
Rituximab for Anti-neutrophil Cytoplasmic Antibodies (ANCA)-Associated Vasculitis (RAVE) Long-Term Follow-Up Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 67
- 试验地点
- 8
- 主要终点
- Long-term safety of rituximab for the treatment of ANCA-associated vasculitis
研究概览
简要总结
Rituximab is the first drug approved by the United States Food and Drug Administration (FDA) for the treatment of patients with granulomatosis with polyangiitis (Wegener's granulomatosis) or microscopic polyangiitis. Because it is a relatively new medication, the long-term safety and efficacy of this drug is not yet clear. This study proposes to follow patients who were enrolled in the RAVE study to determine if treatment with rituximab influences long-term outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 100 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Enrollment in the RAVE trial
- •Completion of RAVE Common Closeout Date visit
- •Informed consent
排除标准
- •Refusal to participate
- •Inability to comply with standard-of-care, including routine clinical visits and testing.
结局指标
主要结局
Long-term safety of rituximab for the treatment of ANCA-associated vasculitis
时间窗: Four years
To determine the long-term safety of rituximab for the treatment of ANCA-associated vasculitis (granulomatosis with polyangiitis (Wegener's granulomatosis) and microscopic polyangiitis).
次要结局
- Disease damage assessed by the increase in Vasculitis Damage Index (VDI)(Four years)
- Renal survival(Four years)
- Malignancy(Four years)
- Disease activity(Four years)
- Disease damage assessed by the ANCA-Vasculitis Index of Damage (AVID)(Four years)
研究者
研究点 (8)
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