Infliximab, Regulatory T Cells, IL2 and Crohn's Disease
| Status: | Completed |
|---|---|
| Conditions: | Gastrointestinal, Crohns Disease |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 70 |
| Updated: | 4/2/2016 |
| Start Date: | December 2010 |
| End Date: | July 2012 |
| Contact: | Zili Zhang, MD |
| Phone: | 5034941078 |
Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease
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.
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.
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.
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.
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.
We found this trial at
1
site
3181 Southwest Sam Jackson Park Road
Portland, Oregon 97239
Portland, Oregon 97239
503 494-8311
Oregon Health and Science University In 1887, the inaugural class of the University of Oregon...
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