CESAR (Randomized Therapeutic Study of Steroid vs. Steroid Plus Cyclosphosphamide for Severe Viscera Henoch-Schoenlein Purpura)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 200
- 试验地点
- 1
- 主要终点
- Birmingham Vasculitis Activity Score (BVAS)
研究概览
简要总结
Henoch-Schonlein purpura is a leucocytoclastic systemic vasculitis involving small vessels with the deposition of immune complexes containing IgA. It is characterized by the association of skin, joint and gastrointestinal manifestations. Even though the evolution is usually simple, some patients, especially adults, may have severe visceral involvement including heart, lung, brain and renal disease. The best treatment is currently unknown. This study will test the safety and efficacy of steroids associated or not with cyclosphosphamide to treat the acute lesions and to prevent the development of chronic lesions.
详细描述
The protocol test the role of 2 modalities of treatment (steroid vs. steroid and cyclophosphamide) for severe systemic form of Henoch-Schonlein purpura. The severe forms include extracapillary glomerulonephritis, myocarditis, pneumonitis, occult involvement, severe gastro-intestinal bleeding. No other randomized trial has been performed in adult patient for this indication.
研究设计
- 研究类型
- Interventional
- 分配方式
- 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
- •Patients with Henoch-Schoenlein purpura
- •Patient's age > 18 years
- •Exclusion criteria:
- •Patient presenting a purpura RHEUMATOID the diagnosis of which is confirmed by the histology presenting at least a visceral infringement(achievement) making consider the affection as engraves(burns)
- •of 18 or more years old Patient
- •Patient capable of understanding(including) the advantages and the risks of the try
- •Patient having given his assent lit in writing
排除标准
- 未提供
研究组 & 干预措施
1
Cyclophosphamide
干预措施: Cyclophosphamide (Drug)
结局指标
主要结局
Birmingham Vasculitis Activity Score (BVAS)
时间窗: during de study
Birmingham Vasculitis Activity Score (BVAS)
次要结局
- Chronic lesions (Vasculitis Damage Index)(during the study)
- Renal function at 12 months(during the study)
- Kidney survival at 12 months(during the study)
- Patient survival at 12 months(during the study)
- Blood pressure(during th study)
- Infections(during the study)
- Adverse events related to steroid or cyclophosphamide(during the study)