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:
2025-12-25 @ 2:07 AM
Ignite Modification Date:
2025-12-25 @ 2:07 AM
NCT ID:
NCT03237260
Eligibility Criteria:
Inclusion Criteria:
* Newly diagnosed active ulcerative colitis, defined as a Mayo Clinic score of 6 to 12
* Prior Sigmoidoscopy sub score of at least 2, and disease that extended 15 cm or more from the anal verge
* Must have required CS for treatment of their symptoms within 2 weeks of diagnosis and have not reached symptom adequate response and they still have moderate to severe disease, indicated by a Mayo score 6 - 12
* In subjects that enroll and are eligible to continue in the study, study drug needs to be started within 3 months of the subject starting corticosteroids
Exclusion Criteria:
* Currently treated with either anti-TNF therapy, immunomodulators or methotrexate due to the severity of their condition, making them not appropriate for vedolizumab
* Toxic megacolon, abdominal abscess, symptomatic colonic stricture, an increased risk of infectious complications
* An anticipated requirement for major surgery, colonic dysplasia or adenomas and malignant neoplasms
* Neurological disorders
* Pregnant or lactating females
* Clinical response to steroids prior to starting study drug
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT03237260
Study Brief:
Protocol Section:
NCT03237260