Comparative Study of the Efficacy of Induction Therapy With Cyclophosphamide or Mycophenolate Mofetil for Non-life-threatening Relapses of PR3- or MPO-ANCA Associated Vasculitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- remission induction rate
研究概览
简要总结
The purpose of this study is to determine the efficacy and safety of a new drug, mycophenolate mofetil, for the treatment of relapses of ANCA-associated vasculitis (Wegener's granulomatosis or microscopic polyangiitis). Therefore, we compare the standard therapy with cyclophosphamide to mycophenolate mofetil.
The investigators expect mycophenolate mofetil to be less toxic and almost equally effective as cyclophosphamide.
详细描述
Treatment of ANCA-associated vasculitis consists of two phases: remission induction with highly effective, but also relatively toxic drugs, and, secondly, after remission is achieved, maintenance therapy with less toxic drugs. The standard induction therapy of a relapse of Wegener's granulomatosis or microscopic polyangiitis consists of the combination of cyclophosphamide and prednisolone. Although this induction therapy is very effective, it is very toxic as well.
Searching for an alternative for cyclophosphamide, we will test the efficacy and safety of a new combination therapy with mycophenolate mofetil and prednisolone. We will compare the effect and safety of the standard induction therapy with the new therapy. When relapses occur, patients will be randomized for either the standard therapy with cyclophosphamide or for mycophenolate mofetil.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- 否
入选标准
- •First or second relapse ANCA-associated vasculitis
- •PR3- or MPO-ANCA antibodies present or histological proof of relapse
排除标准
- •Severe alveolar bleeding or (imminent) respiratory failure
- •Renal failure (serum creatinine >500 umol/L or dialysis)
- •Maintenance therapy before start of study consisting of: cyclophosphamide > 100 mg/day or prednisolone >25 mg/day
- •Intolerance or allergy for cyclophosphamide, mycophenolate mofetil or azathioprine
- •Gravidity or inadequate anticonception
研究组 & 干预措施
1 MMF induction
mycophenolate and steroids as remission induction, followed by azathioprine as maintenance therapy
干预措施: mycophenolate mofetil (Drug)
2 CYC induction
cyclophosphamide and steroids, followed by maintenance therapy (azathioprine)
干预措施: cyclophosphamide (Drug)
结局指标
主要结局
remission induction rate
时间窗: 6 months
disease free survival after 2 and 4 years
时间窗: 2 and 4 years
次要结局
- side-effects(4 years)
- ANCA titres over time(4 years)
- time to remission(9 months)
- cumulative organ damage(4 years)