Infliximab, Regulatory T Cells, IL2 and Crohn's Disease

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2010-12-31

Study Completion Date

2012-07-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Crohn's Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Interventions

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Infliximab

Patient will receive Infliximab infusions during Weeks 0, 2 and 6. Therefore, the duration of the Infliximab treatment will last 6 weeks.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No