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 @ 4:32 PM
Ignite Modification Date:
2025-12-24 @ 4:32 PM
NCT ID:
NCT04879966
Eligibility Criteria:
Inclusion Criteria:
* moderately to severely active ulcerative colitis, defined as a total score of 6 to 12 on the Mayo scale (scores range from 0 to 12, with higher scores indicating more severe disease) and a subscore of at least 2 on the endoscopic component of the Mayo scale (subscores on each of the four components of the Mayo scale range from 0 to 3)
* Patients who had colonic involvement of at least 15 cm
* Patients who had a confirmed diagnosis of ulcerative colitis at least 3 months before screening and confirmed by Pathology
Exclusion Criteria:
* Patients who had previously used any TNF inhibitor
* Patients who were steroid-dependent or steriod-resistant
* Patients who had undergone subtotal colectomy or total colectomy
* Patients who had stoma
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT04879966
Study Brief:
Protocol Section:
NCT04879966