Intestinal Wall Remodeling (Infliximab Therapy) in Crohn's Disease Patients Undergoing Serial Computed Tomography (CT) Enterography
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | January 7, 2009 | ||||
| Last Updated Date | August 17, 2011 | ||||
| Start Date ICMJE | February 2009 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00819663 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE | Not Provided | ||||
| Original Secondary Outcome Measures ICMJE | Not Provided | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Intestinal Wall Remodeling (Infliximab Therapy) in Crohn's Disease Patients Undergoing Serial Computed Tomography (CT) Enterography | ||||
| Official Title ICMJE | Intestinal Wall Remodeling After Initiation of Infliximab Therapy in Crohn's Disease Patients Undergoing Serial CT Enterography | ||||
| 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). |
||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Not Provided | ||||
| Sampling Method | Probability Sample | ||||
| Study Population | (Retrospectively) Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy. |
||||
| Condition ICMJE | Crohn's Disease | ||||
| Intervention ICMJE | Not Provided | ||||
| Study Group/Cohort (s) | Crohns patients
Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy |
||||
| Publications * | 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. Epub 2011 May 5. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 67 | ||||
| Completion Date | August 2010 | ||||
| Primary Completion Date | August 2010 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion criteria
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 80 Years | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00819663 | ||||
| Other Study ID Numbers ICMJE | 08-007338 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | David H. Bruining, MD, Mayo Clinic Rochester, MN | ||||
| Study Sponsor ICMJE | Mayo Clinic | ||||
| Collaborators ICMJE | Centocor Ortho Biotech Services, L.L.C. | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | Mayo Clinic | ||||
| Verification Date | August 2011 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||