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

NCT01266785 | Withdrawn DMC

• 1 other identifier: 6572
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Crohn's Disease

Keywords

crohn's; Infliximab; Inflammatory bowel disease; digestive tract; Interleukin

Outcome Measures

Primary Outcomes (1)

• 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

Interventions

Infliximab DRUG

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

Sponsors & Collaborators

• Oregon Health and Science University: lead
• Centocor, Inc.: collaborator

Study Sites (1)

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Related Publications (4)

• Boschetti G, Nancey S, Sardi F, Roblin X, Flourie B, Kaiserlian D. Therapy with anti-TNFalpha 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.

  PMID: 20848510 BACKGROUND

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

  PMID: 20848485 BACKGROUND

• 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.

  PMID: 20196149 BACKGROUND

• 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.

  PMID: 18422560 BACKGROUND

MeSH Terms

Conditions

Crohn Disease; Inflammatory Bowel Diseases

Interventions

Infliximab

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Zili Zhange, MD, PhD

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Physician

Study Record Dates

• First Submitted: December 23, 2010
• First Posted: December 24, 2010
• Study Start: December 1, 2010
• Primary Completion: July 1, 2012
• Study Completion: July 1, 2012
• Last Updated: May 8, 2019

Record last verified: 2019-05

Locations

US (1)