Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- Changes of IL-2 and Treg cell levels
研究概览
简要总结
Crohn's disease is an inflammatory (swelling and soreness) disorder of the digestive tract. Affected patients suffer from abdominal pains, diarrhea (sometimes bloody), weight loss. It is a lifelong disease with frequent flares during the course of the disease. Crohn's disease is mostly treated with medications, sometimes surgery is needed. Infliximab is a medication for treating severe Crohn's disease. This medicine is effective by blocking special substance (tumor necrosis factor) released from certain white blood cells in the body. Infliximab is given via a vessel at week 0, 2, 6 initially, then every 2 monthly for maintenance. However, some of patients with Crohn's disease do not respond infliximab. Currently there is no test to reveal which patients will respond to treatment. This study aims to analyze and compare particular subgroup of white cells and its products during and after infliximab treatment which may determine the responsiveness to infliximab treatment.
详细描述
All patients will have chest x-ray and pregnancy test (if female) prior to infliximab treatment.
There will be total 5 study visits. At each visit, body weight will be measured, abdominal exam will be performed , 2 tablespoonful of blood will be drawn, stool will be collected, a questionnaire will be completed.
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 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Newly diagnosed or exacerbating CD (Moderate to severe CD).
- •The diagnosis of moderate to severe CD will be confirmed by previous endoscopy and biopsy.
- •Have the capacity to understand and sign an informed consent form.
排除标准
- 未提供
结局指标
主要结局
Changes of IL-2 and Treg cell levels
时间窗: 1 year
To determine if the change of IL-2 and Treg cell levels can be used clinically as a predictive marker for differentiating Infliximab responders from nonresponders
次要结局
未报告次要终点
研究者
Judy Collins
Physician
Oregon Health and Science University