NCT00430807已完成3 期
Multicentric Double Blind Versus Placebo Randomised Study Evaluating the Corticosteroid Sparing Effect of Hydrocyschloroquine in Non Complicated Giant Cell Arteritis.
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 75
- 试验地点
- 38
- 主要终点
- prednisone dosage equal to or lower than 5 mg since more than 3 months without
研究概览
简要总结
Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to immuno-pharmacological and clinical data. We have designed a multcentric double blind versus placebo randomized controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non complicated giant cell arteritis.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •giant celle arteritis with at least 3 ACR criteria including a disgnostic temporal artery biopsy
- •corticosteroid treatment since less than 1 month
- •age less than 85 years
- •signed informed consent
排除标准
- •amaurosis fugax, loss of vision, acute lumb ischemia, angina pectoris or myocardium infarctus, mesenteric ischemia or other vascular complications related to GCA
- •low life expectancy (<2 years)
- •corticosteroid treatment since more than 30 days whatever the dosage
- •primary corticosteroid resistance defined by persistant symptoms despite prednisone for more than 15 days
- •previous psychiatric troubles induced corticosteroids
- •hydroxychloroquine contra-indicated
结局指标
主要结局
prednisone dosage equal to or lower than 5 mg since more than 3 months without
时间窗: 3 months at least
having experienced relapse since the inclusion in the study
次要结局
- hydroxychloroquine blood levels
- prednisone daily dosage(6, 12, 18 and 24 months)
研究者
研究点 (38)
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