Status:
COMPLETED
Intestinal Wall Remodeling (Infliximab Therapy) in Crohn's Disease Patients Undergoing Serial Computed Tomography (CT) Enterography
Lead Sponsor:
Mayo Clinic
Collaborating Sponsors:
Centocor Ortho Biotech Services, L.L.C.
Conditions:
Crohn's Disease
Eligibility:
All Genders
18-80 years
Brief Summary
Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response and can be detected in patients undergoing serial computed tomography enterography (CTE).
Detailed Description
We will retrospectively identify Crohn's disease patients who underwent serial CTE imaging between 2004 and 2008. Approximately 4500 CTEs were performed over this period. We estimate a sample size of ...
Eligibility Criteria
Inclusion
- Inclusion criteria
- Established Crohn's disease
- CTE before and after initiating infliximab
- Underwent at least 2 CTEs between 1/1/2004 and 12/31/2007
- At least 6 months between CTEs
- \*off-label use of infliximab by either increased dose or shortened interval will be included in the study Exclusion criteria
- Small bowel surgery occurring before repeat CTE imaging
- Episodic infliximab therapy (intervals greater than every 8 weeks)
Exclusion
Key Trial Info
Start Date :
February 1 2009
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
67 Patients enrolled
Trial Details
Trial ID
NCT00819663
Start Date
February 1 2009
End Date
August 1 2010
Last Update
August 19 2011
Active Locations (1)
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1
Mayo Clinic
Rochester, Minnesota, United States, 55905