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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2010 by Oregon Health and Science University.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01266785
First Posted: December 24, 2010
Last Update Posted: July 22, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Centocor, Inc.
Information provided by:
Oregon Health and Science University
  Purpose
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.

Condition Intervention
Crohn's Disease Drug: Infliximab

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease

Resource links provided by NLM:


Further study details as provided by Oregon Health and Science University:

Primary Outcome Measures:
  • Changes of IL-2 and Treg cell levels [ Time Frame: 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


Estimated Enrollment: 20
Study Start Date: December 2010
Estimated Study Completion Date: July 2012
Estimated Primary Completion Date: July 2012 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Infliximab
    Patient will receive Infliximab infusions during Weeks 0, 2 and 6. Therefore, the duration of the Infliximab treatment will last 6 weeks.
Detailed Description:

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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01266785


Contacts
Contact: Zili Zhang, MD 5034941078

Locations
United States, Oregon
Oregon Health & Science University Recruiting
Portland, Oregon, United States, 97239
Principal Investigator: Zili Zhang, MD         
Sub-Investigator: Judy Collins, MD         
Sponsors and Collaborators
Oregon Health and Science University
Centocor, Inc.
Investigators
Principal Investigator: Zili Zhange, MD, PhD Oregon Health and Science University
  More Information

Publications:
Responsible Party: Zili Zhang, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier: NCT01266785     History of Changes
Other Study ID Numbers: 6572
First Submitted: December 23, 2010
First Posted: December 24, 2010
Last Update Posted: July 22, 2011
Last Verified: December 2010

Keywords provided by Oregon Health and Science University:
crohn's
Infliximab
Inflammatory bowel disease
digestive tract
Interleukin

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Gastrointestinal Agents
Antirheumatic Agents