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 @ 10:46 PM
Ignite Modification Date:
2025-12-24 @ 10:46 PM
NCT ID:
NCT07271069
Eligibility Criteria:
Inclusion Criteria:
* Participants with Ulcerative Colitis (UC) provided written consent to participate in the study
* Participants who are aged ≥ 18 years at the earlier date of either initiation of treatment with ozanimod or azathioprine or obtaining consent
* Starting dose of oral steroid ≥ 30 mg/day (prednisolone equivalent)
* Administration of ozanimod or azathioprine started after oral steroid administration, and ozanimod or azathioprine administered concomitantly with steroids (excluding patients who started oral steroids and ozanimod or azathioprine on the same day)
* In the ozanimod group, patients with notable clinical symptoms due to the primary disease (rectal bleeding subscore ≥ 1 point or total PRO2 score ≥ 2 points) remained at the start of ozanimod administration
* In the azathioprine group, patients who started azathioprine treatment after February 2019
Exclusion Criteria:
* Participants with symptoms of UC with no change or increase in Patient-Reported Outcome 2 (PRO2) from the time of initiating oral steroid administration after 2 weeks of administration of ≥ 30 mg/day (prednisolone equivalent) of oral steroids
* Participants with complications requiring continued steroid use (excluding topically acting steroids for inhalation or topical application)
* Participants who participated in other clinical studies involving interventions during the observation period
* Participants judged to be inappropriate for enrollment in this study by the investigator at each participating study site
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07271069
Study Brief:
Protocol Section:
NCT07271069