Infliximab Blood Test in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Identify doses and residual levels of infliximab in patients affected by ano-perineal Crohn's disease in remission
研究概览
简要总结
Ano-perineal lesions are the first signs of Crohn's disease in 1/3 to 1/2 of cases. They are most often associated with a poor prognosis of the disease and their management is complex and difficult because of the dilapidated and recurrent nature of lesions with significant repercussions on continence and quality of life.
The treatment of these lesions is most often medical and surgical, consisting of drainage of the suppurative lesions and/or the use of biotherapy +/- combined with an immunosuppressant.
详细描述
Pharmacological dosages of biotherapies show a significant correlation between the highest rates and the achievement of clinical and endoscopic remission. Therapeutic monitoring by dosing the residual levels of these biotherapies and specific antibodies, particularly in the event of loss of response in order to adapt the treatment, has become common for luminal damage. Among these biotherapies, infliximab is the first-line treatment, particularly for ano-perineal disease. Effective therapeutic levels are known for luminal damage and must be between 3 and 7 mcg/ml but these levels have not yet been determined for ano-perineal damage. There are only two recently published studies available that suggest levels probably significantly higher than those required for luminal damage ≥ 10 mcg/l
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •All patients followed for Chron's diseases within Groupe Hospitalier Paris Saint-Joseph (GHPSJ) and treated with Infliximab for at least 6 months.
排除标准
- •All patients with therapeutic compliance problems
结局指标
主要结局
Identify doses and residual levels of infliximab in patients affected by ano-perineal Crohn's disease in remission
时间窗: Time of inclusion
doses and residual levels of infliximab in remission patients will be collected to determine minimum, maximum and average values.
次要结局
- Anti-infliximab antibodies presence (yes/no) in patients with ano-perineal disease in remission versus active(Time of inclusion)
- Compare doses and residual rates of infliximab in patients affected by Crohn's disease in remission with luminal impairment alone versus ano-perineal +/- luminal(Time of inclusion)
- Evaluate the proportion of patients in luminal remission with active ano-perineal disease(Time of inclusion)
- Compare residual doses and infliximab levels in patients with ano-perineal disease in remission versus active(Time of inclusion)