K50
Conditions
Interventions
Group 1: Study participants will receive treatment as part of routine SOC. For the purpose of this study, clinical data, biopsy samples, and imaging assessments will be collected from participants pro
Sponsors
International Bowel Ultrasound Group e.V.
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Participants must meet each of the following criteria for enrolment into the study: 1. Confirmed diagnosis of CD according to standard clinical criteria 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 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
Exclusion criteria
Exclusion criteria: Patients who exhibit any of the following conditions are to be excluded from the study: 1. Patients with a primary diagnosis of ulcerative colitis or IBD type unclassified 2. Patients with ileorectal anastomosis or pouch 3. Patients with prior intestinal surgery less than 6 months prior or history of more than 1 intestinal surgery 4. Disease-related structural bowel complications as defined by CONSTRICT criteria:11 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 5. 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]) 6. Contraindication to IC or MRE 7. Characteristics considered likely to preclude IUS visualization of all bowel segments 8. Disease limited to the rectum 9. 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 10. 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 11. Pregnancy and female patients of child-bearing potential planning a pregnancy during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The longitudinal and construct validity and treatment responsiveness of an IUS CD activity index in an adult population with moderate to severely active CD | — |
Secondary
| Measure | Time frame |
|---|---|
| - The correlation of IUS CD activity index and component items with IC - The correlation of IUS CD activity index and component items with MRE - The correlation of IUS CD activity index and component items with biomarkers - The correlation of IUS CD activity index and component items with clinical activity scores - The correlation of IUS CD activity index and component items with histology - The correlation of IUS CD activity index and component items with HRQoL (SIBDQ) and PRO-2 - The proportion of patients with IUS response and transmural healing after initiation of an SOC biologic and/or JAK inhibitor therapy approved for CD - The longitudinal validity of changes in IUS CD activity and component items after treatment with changes in IC, MRE, biomarkers, clinical disease activity scores, HRQoL (SIBDQ), PRO-2, and histology - The correlation of terminal ileal small bowel peristalsis with IUS CD activity index and component items, MRE, and IC with CD activity - The correlation of IUS CD activity index and component items with patient outcomes, including ED visitation, hospitalization, and surgery. | — |
Countries
Australia, Canada, Germany, Israel, Italy, Netherlands, Portugal, United States
Contacts
Public ContactDaniela Wüller
International Bowel Ultrasound Group
Outcome results
None listed