Validation of an Intestinal Ultrasound Score Evaluating Inflammation and Treatment Response in Crohn*s Disease (USE-IT): A Prospective Multicenter Study.
- Conditions
- Crohn's DiseaseInflammatory Bowel Disease10017969
- Registration Number
- NL-OMON53838
- Lead Sponsor
- International Bowel Ultrasound Group (IBUS)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 5
1. Confirmed diagnosis of CD according to standard clinical, endoscopic, and
histologic criteria of at least 3 months duration
2. Adults 18 years of age or older
3. Moderate to severely active CD defined by:
a. Active symptoms with an HBI score >= 5, and
b. Bowel wall inflammation defined as bowel wall thickness (BWT) > 3 mm in at
least 1 segment of the ileum or colon as determined by IUS
4. Patients with planned introduction of an SOC biologic and/or JAK inhibitor
therapy approved for CD as per their treating gastroenterologist to treat
active disease
5. Written informed consent must be obtained and documented
1. Patients with a primary diagnosis of ulcerative colitis or IBD type
unclassified
2. Patients with prior intestinal surgery
3. Disease-related structural bowel complications as defined by CONSTRICT
criteria
a. Localized luminal narrowing (luminal diameter reduction of at least 50%
relative to normal adjacent bowel loop), and
b. Bowel wall thickening (25% increase relative to adjacent unaffected bowel),
and
c. Either: maximum associated small bowel dilation (luminal diameter greater
than or equal to 3 cm) OR inability to pass an adult or pediatric colonoscope
through the narrowed area prior to dilation and unequivocal proximal small
bowel dilation (but may be less than 3 cm). Endoscopic diagnosis of stricture
should be within 6 months of MRE
4. Disease-related penetrating complications (excluding perianal fistulizing
disease; patients with perianal disease are eligible if there is additional
inflammation in another bowel segment [other than the rectum])
5. Contraindication to IC or MRE
6. BMI greater than 35 at time of screening or other characteristics considered
likely to preclude IUS visualization of all bowel segments
7. Disease limited to the rectum
8. Serious underlying disease other than CD that in the opinion of the
investigator may interfere with the participant*s ability to participate fully
in the study
9. History of alcohol or drug abuse that in the opinion of the investigator may
interfere with the participant*s ability to comply with the study procedures
10. Pregnancy and female patients of child-bearing potential planning a
pregnancy during the study period
Study & Design
- Study Type
- Observational invasive
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>• The longitudinal and construct validity and treatment responsiveness of an<br /><br>IUS CD activity index in an adult population with moderate to severely active<br /><br>CD</p><br>
- Secondary Outcome Measures
Name Time Method