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| Name | Class |
|---|---|
| Centocor Ortho Biotech Services, L.L.C. | INDUSTRY |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Crohns patients | Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy |
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| Measure | Description | Time Frame |
|---|---|---|
| Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response and can be detected in patients undergoing serial computed tomography enterography (CTE). | 2004-2008 |
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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)
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(Retrospectively) Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy.
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| Name | Affiliation | Role |
|---|---|---|
| David H Bruining, MD | Mayo Clinic | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Rochester | Minnesota | 55905 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21621641 | Result | 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. |
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| ID | Term |
|---|---|
| D003424 | Crohn Disease |
| ID | Term |
|---|---|
| D015212 | Inflammatory Bowel Diseases |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| D007410 | Intestinal Diseases |