Treatment of Necrotizing Vasculitides for Patients Older Than 65 Years Comparison of Two Strategies Combining Steroids With or Without Immunosuppressants
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 108
- 试验地点
- 1
- 主要终点
- Number of side effects (morbidity)
研究概览
简要总结
The aim of this trial is to lower the morbidity rate in elderly patients affected with systemic necrotizing vasculitides, by reducing mortality and improving global outcome.
详细描述
Systemic necrotizing vasculitides are severe diseases associated with a high mortality rate in elderly.
Although corticosteroids and immunosuppressants are effective, they can induce some side-effects, especially in this latter patients.
Preliminary data indicate that systemic necrotizing vasculitides (SNV) occurring in patients over 65 years have a poorer outcome than in younger patients (mortality rate of 76 % vs. 69 % at 5 years, respectively) and that 68,4 % of the elderly experience treatment side-effects.
In this trial, patients will be randomly assigned to receive either low doses of corticosteroids systematically in combination with immunosuppressants (CYC then azathioprine) or usual regimen with corticosteroids combined with immunosuppressants only if factor(s) of poor prognosis is present (this latter regimen relying on previously published therapeutic guidelines).
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
- 65 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed WG, MPA, PAN without HBV infection, or CSS
- •Patients can be still be enrolled within 1 month after starting corticosteroids if prescribed according to protocol.
- •within or after the 65th of anniversary
- •Age ≥ 65 years
排除标准
- •Any cytotoxic drug within previous year
- •Co-existence of another systemic autoimmune disease, e.g., SLE, RA
- •Virus-associated vasculitides
- •HIV positivity
- •Malignancy (usually excluded unless approved by the trial coordinator)
- •Age < 65 years
- •Inability to give informed consent
研究组 & 干预措施
A
conventional treatment
干预措施: prednisone, methylprednisolone,cyclophosphamides (Drug)
A
conventional treatment
干预措施: Mycophenolate mofetil,methotrexate (Drug)
B
reduction dose
干预措施: Cyclophosphamide, Azathioprine,prednisone,methylprednisolone (Drug)
B
reduction dose
干预措施: Mycophenolate mofetil,methotrexate (Drug)
结局指标
主要结局
Number of side effects (morbidity)
时间窗: at 3 years
次要结局
- Survival(at 3 years)
- Efficacy of treatment (remission rate)(during the 3 years)
- Relapse rate(at 3 years)
- Cumulative dose exposure to OCS and AZA(at 3 years)
- Cumulative BVAS (AUC), VDI, HAQ-DI, SF-36 values(at 3 years)