Infliximab, Regulatory T Cells, IL2 and Crohn's Disease
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状态
赞助商
Oregon Health and Science University
合作者
Centocor, Inc.
临床试验: NCT01266785
BioSeek: NCT01266785
关键词
抽象
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.
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.
日期
| 最后验证: | 04/30/2019 |
| 首次提交: | 12/22/2010 |
| 提交的预估入学人数: | 12/22/2010 |
| 首次发布: | 12/23/2010 |
| 上次提交的更新: | 05/05/2019 |
| 最近更新发布: | 05/07/2019 |
| 实际学习开始日期: | 11/30/2010 |
| 预计主要完成日期: | 06/30/2012 |
| 预计完成日期: | 06/30/2012 |
状况或疾病
Crohn's Disease
干预/治疗
Drug: Infliximab
相
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资格标准
| 有资格学习的年龄 | 18 Years 至 18 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 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. |
结果
主要结果指标
1. Changes of IL-2 and Treg cell levels [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
