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

Crohn's Disease Clinical Trial

Official title:

Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01266785
• Other study ID #: 6572
• Status: Withdrawn
• Phase: N/A
• Start date: December 2010
• Est. completion date: July 2012

Study information

• Verified date: May 2019
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: July 2012
• Est. primary completion date: July 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Crohn Disease
• Crohn's Disease

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Health & Science University	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Centocor, Inc.

Country where clinical trial is conducted

United States, 

References & Publications (4)

Boschetti G, Nancey S, Sardi F, Roblin X, Flourié B, Kaiserlian D. Therapy with anti-TNFa antibody enhances number and function of Foxp3(+) regulatory T cells in inflammatory bowel diseases. Inflamm Bowel Dis. 2011 Jan;17(1):160-70. doi: 10.1002/ibd.21308. — View Citation

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-ß: relationship with clinical response to infliximab in Crohn's disease. Inflamm Bowel Dis. 2010 Nov;16(11):1891-7. doi: 10.1002/ibd.21271. — View Citation

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. doi: 10.1002/ibd.21229. — View Citation

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. doi: 10.1111/j.1365-2567.2008.02839.x. Epub 2008 Apr 16. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of IL-2 and Treg cell levels	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	1 year