Infliximab, Regulatory T Cells, IL2 and Crohn's Disease
Primary Purpose
Crohn's Disease
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Infliximab
Sponsored by
About this trial
This is an interventional treatment trial for Crohn's Disease focused on measuring crohn's, Infliximab, Inflammatory bowel disease, digestive tract, Interleukin
Eligibility 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.
Sites / Locations
- Oregon Health & Science University
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT01266785
First Posted
December 23, 2010
Last Updated
May 6, 2019
Sponsor
Oregon Health and Science University
Collaborators
Centocor, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT01266785
Brief Title
Infliximab, Regulatory T Cells, IL2 and Crohn's Disease
Official Title
Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Withdrawn
Why Stopped
Lack of enrollment
Study Start Date
December 2010 (undefined)
Primary Completion Date
July 2012 (Anticipated)
Study Completion Date
July 2012 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Oregon Health and Science University
Collaborators
Centocor, Inc.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Crohn's Disease
Keywords
crohn's, Infliximab, Inflammatory bowel disease, digestive tract, Interleukin
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Infliximab
Intervention Description
Patient will receive Infliximab infusions during Weeks 0, 2 and 6. Therefore, the duration of the Infliximab treatment will last 6 weeks.
Primary Outcome Measure Information:
Title
Changes of IL-2 and Treg cell levels
Description
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
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zili Zhange, MD, PhD
Organizational Affiliation
Oregon Health and Science University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Oregon Health & Science University
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
20848510
Citation
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.
Results Reference
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PubMed Identifier
20848485
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-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.
Results Reference
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PubMed Identifier
20196149
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.
Results Reference
background
PubMed Identifier
18422560
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.
Results Reference
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Infliximab, Regulatory T Cells, IL2 and Crohn's Disease
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