Cyclophosphamide Versus Methotrexate for Remission Maintenance in Systemic Necrotizing Vasculitides. A Randomized Controlled Trial.
试验速览
- 阶段
- 2 期
- 试验地点
- 1
- 主要终点
- Time from remission to relapse
研究概览
简要总结
The Systemic Necrotizing Vasculitides (SNV) encompass a group of rare diseases which include Wegener's Granulomatosis (WG), Churg-Strauss Syndrome (CSS), Microscopic polyangiitis (MPA)and Polyarteritis nodosa (PAN). Common histological findings are inflammation with fibrinoid necrosis of the small vessels and sporadic or absent immune-deposits. The gold standard therapy for SNV is currently represented by the association of Cyclophosphamide and Prednisone. The limits of this approach are the high frequency of recurrent disease and an increased incidence of malignancy and infections. The aim of the present study is to compare the efficacy of Methotrexate vs Cyclophosphamide for Remission Maintenance in SNV.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of clinically active SNV
- •Life-expectancy > 1 year
- •Written informed consent
排除标准
- •Creatinine clearance < 10 ml/min/1.73 mq
- •Aminotransferase levels more than twice the upper limit of the normal range
- •HBsAg positivity
- •anti-HCV Ig and HCV-RNA positivity
- •HIV positivity
- •Active malignancies
- •Coexistence of connective tissue disease
- •Prednisolone, cyclophosphamide or methotrexate hypersensitivity
- •Pregnancy
研究组 & 干预措施
A
Cyclophosphamide
干预措施: Cyclophosphamide (Drug)
B
Methotrexate
干预措施: Methotrexate (Drug)
结局指标
主要结局
Time from remission to relapse
次要结局
- Recurrence rate
- Therapy-related toxicity
- Hospitalization rate
- Mortality