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

The recruitment status of this study is unknown because the information has not been verified recently.

Verified December 2010 by Oregon Health and Science University.
Recruitment status was Recruiting

Sponsor:

Collaborator:

Centocor, Inc.

Information provided by:

Oregon Health and Science University

ClinicalTrials.gov Identifier:

NCT01266785

First received: December 23, 2010

Last updated: July 20, 2011

Last verified: December 2010

History of Changes

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 Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: 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:

Genetics Home Reference related topics: Crohn disease

MedlinePlus related topics: Crohn's Disease

Drug Information available for: Infliximab

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]
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:

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

Other Name: Infliximab

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

Ages Eligible for Study:	18 Years to 70 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: 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:

Boschetti G, Nancey S, Sardi F, Roblin X, Flourié B, Kaiserlian D. Therapy with anti-TNF? antibody enhances number and function of Foxp3(+) regulatory T cells in inflammatory bowel diseases. Inflamm Bowel Dis. 2011 Jan;17(1):160-70.

Di Sabatino A, Biancheri P, Piconese S, Rosado MM, Ardizzone S, Rovedatti L, Ubezio C, Massari A, Sampietro GM, Foschi D, Porro GB, Colombo MP, Carsetti R, MacDonald TT, Corazza GR. Peripheral regulatory T cells and serum transforming growth factor-?: relationship with clinical response to infliximab in Crohn's disease. Inflamm Bowel Dis. 2010 Nov;16(11):1891-7.

Li Z, Arijs I, De Hertogh G, Vermeire S, Noman M, Bullens D, Coorevits L, Sagaert X, Schuit F, Rutgeerts P, Ceuppens JL, Van Assche G. Reciprocal changes of Foxp3 expression in blood and intestinal mucosa in IBD patients responding to infliximab. Inflamm Bowel Dis. 2010 Aug;16(8):1299-310.

Ricciardelli I, Lindley KJ, Londei M, Quaratino S. Anti tumour necrosis-alpha therapy increases the number of FOXP3 regulatory T cells in children affected by Crohn's disease. Immunology. 2008 Oct;125(2):178-83. Epub 2008 Apr 16.

Responsible Party:	Zili Zhang, MD, Oregon Health and Science University
ClinicalTrials.gov Identifier:	NCT01266785 History of Changes
Other Study ID Numbers:	6572
Study First Received:	December 23, 2010
Last Updated:	July 20, 2011
Health Authority:	United States: Institutional Review Board

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
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on May 23, 2013

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