Validation of an Intestinal Ultrasound Score Evaluating Inflammation and Treatment Response in Crohn's Disease (USE-IT): A Prospective Multicenter Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Enrollment
- 110
- Locations
- 1
- Primary Endpoint
- The longitudinal and construct validity and treatment responsiveness of an IUS CD activity index in an adult population with moderate to severely active CD
Study Overview
Brief Summary
The primary objective of this study is to prospectively validate a novel intestinal ultrasound (IUS) Crohn's disease (CD) activity index and component items, correlating CD activity and responsiveness to therapy as evaluated by IUS with evaluations by ileocolonoscopy (IC) (Simple Endoscopic Score for Crohn's disease [SES-CD]) and magnetic resonance enterography (MRE) (Simplified Magnetic Resonance Index of Activity [MaRIA] score).
Detailed Description
Study Design Prospective multicenter study of 111 participants with CD with 50 weeks of follow-up Study Population Adult patients with moderately to severely active CD
Inclusion Criteria:
-
Confirmed diagnosis of CD according to standard clinical, endoscopic, and histologic criteria of at least 3 months duration
-
Adults 18 years of age or older
-
Moderate to severely active CD defined by:
-
Active symptoms with a HBI ≥ 8, and
-
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
-
Patients with planned introduction of biologic therapy as per their treating gastroenterologist to treat active disease
-
Written informed consent must be obtained and documented
Exclusion Criteria:
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Confirmed diagnosis of CD according to standard clinical, endoscopic, and histologic criteria of at least 3 months duration
- •Adults 18 years of age or older
- •Moderate to severely active CD defined by:
- •Active symptoms with a HBI ≥ 8, and
- •Bowel wall inflammation defined as BWT > 3 mm in at least 1 segment of the ileum or colon as determined by IUS
- •Patients with planned introduction of biologic therapy as per their treating gastroenterologist to treat active disease
- •Written informed consent must be obtained and documented.
Exclusion Criteria
- •Patients with a primary diagnosis of ulcerative colitis or IBD type unclassified
- •Patients with prior intestinal surgery
- •Patients with disease-related structural bowel complications defined as either:
- •Stricture with increased bowel wall thickening (>25% of normal), decreased luminal diameter (>50% relative to the normal adjacent bowel loop) and proximal dilation (on any imaging modality) or;
- •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]).
- •Contraindication to IC or MRE
- •BMI greater than 35 at time of screening or other characteristics considered likely to preclude IUS visualization of all bowel segments
- •Disease limited to the rectum
- •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
- •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
Outcomes
Primary Outcomes
The longitudinal and construct validity and treatment responsiveness of an IUS CD activity index in an adult population with moderate to severely active CD
Time Frame: week 0 to week 50
The newly formed activity index determined by intestinal ultrasound is compared with the results of colonoscopy (IC), MRE, blood and stool markers.
Secondary Outcomes
- The correlation of IUS CD activity index and component items with IC(week 0 to week 50)
- The correlation of IUS CD activity index and component items with MRE(week 0 to week 50)
- The correlation of IUS CD activity index and component items with HRQoL (SIBDQ) and PRO-2(week 0 to week 50)
- The correlation of IUS CD activity index and component items with biomarkers(week 0 to week 50)
- The correlation of IUS CD activity index and component items with histology(week 0 to week 50)