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
  Purpose

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


Condition
Crohn's Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Intestinal Wall Remodeling After Initiation of Infliximab Therapy in Crohn's Disease Patients Undergoing Serial CT Enterography

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ]

Enrollment: 67
Study Start Date: February 2009
Study Completion Date: August 2010
Primary Completion Date: August 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Crohns patients
Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy

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 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).

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

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

Criteria

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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00819663

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Centocor Ortho Biotech Services, L.L.C.
Investigators
Principal Investigator: David H Bruining, MD Mayo Clinic
  More Information

Publications:
Responsible Party: David H. Bruining, MD, Mayo Clinic Rochester, MN
ClinicalTrials.gov Identifier: NCT00819663     History of Changes
Other Study ID Numbers: 08-007338
Study First Received: January 7, 2009
Last Updated: August 17, 2011
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
Infliximab
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions
Gastrointestinal Agents
Antirheumatic Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on April 16, 2014