Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT05407350
Eligibility Criteria:
Inclusion Criteria:
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:
1. Active symptoms with a HBI ≥ 8, and
2. 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 biologic therapy as per their treating gastroenterologist to treat active disease
5. Written informed consent must be obtained and documented.
Exclusion Criteria:
1. Patients with a primary diagnosis of ulcerative colitis or IBD type unclassified
2. Patients with prior intestinal surgery
3. Patients with disease-related structural bowel complications defined as either:
1. 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;
2. Penetrating complications (excluding perianal fistulizing disease; patients with perianal disease are eligible if there is additional inflammation in another bowel segment \[other than the rectum\]).
4. Contraindication to IC or MRE
5. BMI greater than 35 at time of screening or other characteristics considered likely to preclude IUS visualization of all bowel segments
6. Disease limited to the rectum
7. 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
8. 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
9. Pregnancy
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05407350
Study Brief:
Protocol Section:
NCT05407350