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 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT01458951
Eligibility Criteria:
Inclusion Criteria:
* Subject must be at least 18 years of age.
* Males and females with a documented diagnosis of UC at least 4 months prior to entry into the study.
* Subjects with moderately to severely active UC based on Mayo score criteria.
* Subjects must have failed or be intolerant of at least one of the following treatments for UC:
* Corticosteroids (oral or intravenous).
* Azathioprine or 6 mercaptopurine (6 MP).
* Anti TNF therapy.
Exclusion Criteria:
* Presence of indeterminate colitis, microscopic colitis, ischemic colitis, infectious colitis, or clinical findings suggestive of Crohn's disease.
* Subjects with disease limited to distal 15 cm.
* Subjects without previous treatment for UC (ie, treatment naïve).
* Subjects displaying clinical signs of fulminant colitis or toxic megacolon.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01458951
Study Brief:
Protocol Section:
NCT01458951