NCT00307658终止3 期
Intravenous Immunoglobulin After Relapse in Vasculitis (Microscopic Polyangiitis, Wegener's Granulomatosis and SHURG-STRAUSS Syndrome) During and After Corticosteroids and Immunosuppressant Therapies a Multicenter Prospective Trial
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 40
- 试验地点
- 4
- 主要终点
- the remission rate after 9 months of therapy with intravenous immunoglobulins,
研究概览
简要总结
The aim of this study is to study the efficacy of intravenous immunoglobulins for inducing remission in patients relapsing of systemic vasculitides.
详细描述
The aim of this study will assess the effects of intravenous immunoglobulin in ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome) who relapse under corticosteroid and immunosuppressant therapies or after one year post treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 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
- •Wegener's granulomatosis, Microscopic polyangiitis and Churg-Strauss syndrome (satisfying ACR or chapel Hill classification) relapsing either under corticosteroid and immunosuppressant therapies or after one year post treatment
- •Age > 18 years old
- •Written informed consent
排除标准
- •Systemic vasculitides not previously treated with corticosteroid and immunosuppressant(s)
- •Systemic vasculitides treated with corticosteroids and immunosuppressant therapies, but with treatment cessation more than 12 months ago
- •Polyarteritis nodosa
- •Absence of poor prognosis criteria (according to FFS)
- •Nephritis ± renal impairment
- •Cancer or malignancy
- •Psychiatric disease, lack of compliance
- •Age under 18 years old
- •Lack of written informed consent
- •Other vasculitides (post viral infection and skin localisation)
结局指标
主要结局
the remission rate after 9 months of therapy with intravenous immunoglobulins,
in relapsing patients with ANCA+ vasculitides (Microscopic Polyangiitis, Wegener's granulomatosis and Churg-Strauss syndrome)
during 6 months, after relapse
次要结局
- Safety, i.e. side-effects classified according to the WHO guidelines
研究者
研究点 (4)
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