Intestinal Wall Remodeling (Infliximab Therapy) in Crohn's Disease Patients Undergoing Serial Computed Tomography (CT) Enterography

This study has been completed.
Sponsor:
Collaborator:
Centocor Ortho Biotech Services, L.L.C.
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00819663
First received: January 7, 2009
Last updated: August 17, 2011
Last verified: August 2011

January 7, 2009
August 17, 2011
February 2009
August 2010   (final data collection date for primary outcome measure)
Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response and can be detected in patients undergoing serial computed tomography enterography (CTE). [ Time Frame: 2004-2008 ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00819663 on ClinicalTrials.gov Archive Site
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Intestinal Wall Remodeling (Infliximab Therapy) in Crohn's Disease Patients Undergoing Serial Computed Tomography (CT) Enterography
Intestinal Wall Remodeling After Initiation of Infliximab Therapy in Crohn's Disease Patients Undergoing Serial CT Enterography

Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response and can be detected in patients undergoing serial computed tomography enterography (CTE).

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 50 Crohn's disease patients who have had CTE performed before and after infliximab therapy was initiated. We will analyze each CTE for the presence of penetrating disease, number of inflammatory lesion, length of each lesion, and severity of each lesion (degree of enhancement, wall thickness, stratification, vascular engorgement, fatty proliferation, and symmetry). Degree of enhancement and thickness will be graded on a 5-point scale. Stratification, vascular engorgement, fatty proliferation, and symmetry will be treated as dichotomous variables (yes/no). Only small bowel lesions will be described. A GI radiologist (JGF), blinded to the clinical information and previous imaging results, will provide the readings. Comparisons between CTEs will be performed to determine responders (all lesions improved), mixed responders (not all lesions improved), and refractory (no lesion improved). A descriptive pattern of healing will also be recorded for each lesion. Clinical data to be recorded include indication for CTE, time between CTE, dates of each CTE, date on first infliximab infusion, dose of infliximab, interval between infusions, history of penetrating disease, history of surgery, clinical status at imaging (remission, flare, or uncertain), medication usage, age, and disease duration. Clinical status at time of imaging will be based on the ordering clinician's global assessment at the time of repeat CTE. This will be determined by a review of the medical record by a gastroenterologist (DHB).

Observational
Observational Model: Cohort
Time Perspective: Retrospective
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Probability Sample

(Retrospectively) Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy.

Crohn's Disease
Not Provided
Crohns patients
Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy
Bruining DH, Loftus EV Jr, Ehman EC, Siddiki HA, Nguyen DL, Fidler JL, Huprich JE, Mandrekar JN, Harmsen WS, Sandborn WJ, Fletcher JG. Computed tomography enterography detects intestinal wall changes and effects of treatment in patients with Crohn's disease. Clin Gastroenterol Hepatol. 2011 Aug;9(8):679-683.e1. doi: 10.1016/j.cgh.2011.04.025. Epub 2011 May 5.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
67
August 2010
August 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00819663
08-007338
Yes
David H. Bruining, MD, Mayo Clinic Rochester, MN
Mayo Clinic
Centocor Ortho Biotech Services, L.L.C.
Principal Investigator: David H Bruining, MD Mayo Clinic
Mayo Clinic
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP