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

NCT ID: NCT00819663

Last Updated: 2011-08-19

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 67 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2010-08-31

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 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).

Conditions

Crohn's Disease

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: RETROSPECTIVE

Study Groups

Crohns patients

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

No interventions assigned to this group

Eligibility 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

Exclusion Criteria

• Small bowel surgery occurring before repeat CTE imaging
• Episodic infliximab therapy (intervals greater than every 8 weeks)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Centocor Ortho Biotech Services, L.L.C.

INDUSTRY

Sponsor Role: collaborator

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic Rochester, MN

Principal Investigators

David H Bruining, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21621641 (View on PubMed)

Other Identifiers

08-007338

Identifier Type: -

Identifier Source: org_study_id