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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.
Last refreshed on: 12 December 2020
Main ID:  NCT01266785
Date of registration: 23/12/2010
Prospective Registration: Yes
Primary sponsor: Oregon Health and Science University
Public title: Infliximab, Regulatory T Cells, IL2 and Crohn's Disease
Scientific title: Analysis of Relationship Between Infliximab Treatment Response, Regulatory T Cells, and Interleukin-2 in Crohn's Disease
Date of first enrolment: December 2010
Target sample size: 0
Recruitment status: Withdrawn
Study type:  Interventional
Study design:  Allocation: Non-Randomized. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).  
Phase:  N/A
Countries of recruitment
United States
Name:     Zili Zhange, MD, PhD
Affiliation:  Oregon Health and Science University
Key inclusion & exclusion 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

- Have the capacity to understand and sign an informed consent form.

Age minimum: 18 Years
Age maximum: 70 Years
Gender: All
Health Condition(s) or Problem(s) studied
Crohn's Disease
Drug: Infliximab
Primary Outcome(s)
Changes of IL-2 and Treg cell levels [Time Frame: 1 year]
Secondary Outcome(s)
Secondary ID(s)
Source(s) of Monetary Support
Please refer to primary and secondary sponsors
Secondary Sponsor(s)
Centocor, Inc.
Ethics review
Results available:
Date Posted:
Date Completed:
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