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 @ 11:28 PM
Ignite Modification Date:
2025-12-24 @ 11:28 PM
NCT ID:
NCT04733456
Eligibility Criteria:
Inclusion Criteria:
Eligible patients will be:
* \> 18 years of age with moderate-to-severe UC or (partial Mayo score \[excluding endoscopy\] ≥5 with rectal bleeding subscore ≥1; or total Mayo subscore 6-12 with RBS ≥1) or CD (Harvey-Bradshaw index \[HBI\] of 7 or greater, and active CD confirmed on POC bowel ultrasound (defined by bowel wall thickness \>3mm and positive Color doppler signal and a fecal calprotectin \> 50 μg/g ).
* based on their active disease status patients cannot be taking \> 20 mg prednisone daily and
* must be eligible for anti-TNF therapy as per standard of care (clinical decision made by IBD specialist caring for the patient).
Exclusion Criteria:
* patients with severely active UC (clinical signs of fulminant colitis or toxic megacolon) or CD (HBI \> 16), requiring \> 20 mg of prednisone daily at induction, suicidal ideation or psychosis.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
85 Years
Study:
NCT04733456
Study Brief:
Protocol Section:
NCT04733456