Crohn's DiseaseNCT00819663
Intestinal Wall Remodeling (Infliximab Therapy) in Crohn's Disease Patients Undergoing Serial Computed Tomography (CT) Enterography
An observational study of Crohn's Disease, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Crohn's Disease
- How many people
- 67 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2009to Aug 2010
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: (Retrospectively) Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy.
Who may be able to join
- 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)
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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
- Medical subject headings
- Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Crohns patients | Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anti-TNF therapy induces intestinal wall remodeling that correlates with clinical response and can be detected in patients undergoing serial computed tomography enterography (CTE).
Measured: 2004-2008
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jan 2009 (estimated)
- Study startFeb 2009
- Primary completionAug 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Crohn's DiseaseStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Investigators
- David H Bruining, MD, Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00819663
- Sponsor's protocol ID
- 08-007338
- Status last verified
- Aug 2011
- First submitted
- 7 Jan 2009
- Last updated
- 19 Aug 2011
- Results posted
- No
- Data monitoring committee
- Yes
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. doi: 10.1016/j.cgh.2011.04.025. Epub 2011 May 5.
PubMed 21621641
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intestinal Wall Remodeling After Initiation of Infliximab Therapy in Crohn's Disease Patients Undergoing Serial CT Enterography
- ClinicalTrials.gov ID
- NCT00819663
- Acronym / sponsor ID
- 08-007338
- Conditions
- Crohn's Disease
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Centocor Ortho Biotech Services, L.L.C.
- Study start
- Feb 2009
- Primary completion
- Aug 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 9 Jan 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Crohns patients | – | –Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- (Retrospectively) Established Crohn's disease patients who underwent CTE imaging before and after initiating infliximab therapy.
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2011.
- Results publication: PubMed 21621641Bruining 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.
Related trials for Crohn's Disease
RecruitingObservational study
Ibd CAncer and seRious Infections in France (I-CARE 2)
IBD, Ulcerative Colitis
Enrolling by invitationPhase 4
MOdel-Informed Precision Dosing of Ustekinumab and VEdolizumab in Inflammatory Bowel Disease
Inflammatory Bowel Diseases, Crohn Disease
RecruitingObservational study
Longitudinal Immunophenotyping of Patients With Inflammatory Bowel Disease
Inflammatory Bowel Disease, Crohn's Disease
RecruitingObservational study
Characterization of Colorectal Dysplasic Lesions and Stratification of Their Evolving Risk in Inflammatory Bowel Disease Patients: a Prospective, Observational and Multicenter Study
Crohn Disease (CD), Colitis Ulcerative
Not yet recruitingPhase 1
An Open-label, DDI Study to Investigate the Effects of Duvakitug on the PK of Selected Cytochrome P450 Substrates
Ulcerative Colitis, Crohn's Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David H Bruining, MD principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Crohn's Disease, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00819663, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2011.