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


N/A
18 Years
70 Years
Open (Enrolling)
Both
Crohn's Disease

Thank you

Trial Information

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


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Changes of IL-2 and Treg cell levels

Outcome 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

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Zili Zhange, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Oregon Health and Science University

Authority:

United States: Institutional Review Board

Study ID:

6572

NCT ID:

NCT01266785

Start Date:

December 2010

Completion Date:

July 2012

Related Keywords:

  • Crohn's Disease
  • crohn's
  • Infliximab
  • Inflammatory bowel disease
  • digestive tract
  • Interleukin
  • Crohn Disease

Name

Location

Oregon Health & Science UniversityPortland, Oregon  97201