NCT01400464Unknown4 期
Study the Link Between Steroids Pharmacokinetics and the Response to Prednisone Therapy in Giant Cell Arteritis
适应症
相关药物
试验速览
- 阶段
- 4 期
- 入组人数
- 150
- 试验地点
- 24
- 主要终点
- oral clearance of prednisolone
研究概览
简要总结
The factors underlying the large interindividual variability in response to glucocorticoids in Giant Cell Arteritis are poorly understood. The investigators hypothesize that a part of this variability is related to pharmacokinetic factors determined by genetic polymorphism: hepatic clearance involving cytochromes P450 of the subfamily 3A (CYP3A) and drug efflux leukocyte conditioned by P-glycoprotein involved in multidrug resistance drugs (ABCB1). The investigators have designed a multicentric prospective pharmacokinetical and pharmacogenetic cohort study to assess the link between prednisolone clearance and the relapse risk in giant cell arteritis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of GCA, meeting at least 3 of the following 5 American College of Rheumatology (ACR) criteria for the diagnosis of GCA:
- •At least 50 years of age at disease onset
- •New onset or new type of localized pain in the head
- •Temporal artery abnormality (i.e., temporal artery tenderness to palpation or decreased pulsation unrelated to arteriosclerosis of cervical arteries)
- •ESR of greater than 40 mm in the first hour by the Westergren method
- •Temporal artery biopsy showing vasculitis characterized by a predominance of mononuclear cell infiltration or granulomatous inflammation, usually with multinucleated giant cells
- •Corticoid treatment since less than 14 days
- •Signed informed consent
- •Affiliation to the social security system
排除标准
- •Predictable non observance
- •Neoplasia since less than 5 years
结局指标
主要结局
oral clearance of prednisolone
时间窗: 2 to 4 weeks after begining prednisolone treatment
次要结局
未报告次要终点
研究者
研究点 (24)
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