Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis
The purpose of this study is to evaluate the effectiveness and safety of ozanimod vs azathioprine for the treatment of ulcerative colitis (UC) in real-world clinical practice in Japan
| Condition(s) | Ulcerative Colitis (UC) |
|---|---|
| Status | Recruiting |
| Study type | Observational |
| Summary | The purpose of this study is to evaluate the effectiveness and safety of ozanimod vs azathioprine for the treatment of ulcerative colitis (UC) in real-world clinical practice in Japan |
| Who can participate | 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 a |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Bristol-Myers Squibb |
| Locations | Chiba, Chiba, Japan; Kashiwa-shi, Chiba, Japan; Sakura, Chiba, Japan; Matsuyama, Ehime, Japan; Chikushino-shi, Fukuoka, Japan; Fukuoka, Fukuoka, Japan (+12 more sites) |
| Start date | 2026-01-29 |
| NCT ID | NCT07271069 |
| Official listing | https://clinicaltrials.gov/study/NCT07271069 |