What is this study trying to find out about ulcerative colitis?

This study is assessing how well ozanimod compares to azathioprine for treating steroid-dependent ulcerative colitis in real-world clinical practice. Researchers aim to understand which treatment helps patients achieve symptom relief without steroids. The study is sponsored by Bristol-Myers Squibb and focuses on patient experiences in Japan.

Who may be eligible for this ulcerative colitis clinical trial?

Adults aged 18 or older with ulcerative colitis who have started oral steroids at 30 mg/day or more and then began treatment with ozanimod or azathioprine may be eligible. Both males and females can participate. People who are currently in other treatment clinical trials or have certain complications needing ongoing steroid use may not qualify. Please review eligibility criteria for more details.

Is there any cost to participate in this ulcerative colitis clinical trial?

Study-related care, including the study drugs and all trial visits, is provided at no cost. However, personal travel and other expenses may vary and are not guaranteed to be covered. Participants should plan accordingly for any additional costs.

Actively Recruiting

Age: 18Years +

All Genders

ID07271069

Real-world Study Comparing Ozanimod and Azathioprine for Treating Steroid-Dependent Ulcerative Colitis in Adults in Japan

Led by Bristol-Myers Squibb · Updated on 2026-05-18

150

Participants Needed

Research Sites

39 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the effectiveness and safety of two drugs, ozanimod and azathioprine, for treating ulcerative colitis UC in patients who depend on steroids. This observational study focuses on real-world clinical practice in Japan and is sponsored by Bristol-Myers Squibb. The goal is to compare the treatments to better understand their impact on symptom remission and steroid use in UC patients. Participants will be divided into two groups those receiving ozanimod and those receiving azathioprine. Both drugs are given according to their product labels. The study specifically looks at patients who start these medications after beginning oral steroid treatment at doses of 30 mgday or higher, with some differences in symptom requirements for each group. Treatment continuation and steroid use are tracked over a 52-week period. During the study, researchers will monitor participants for steroid-free symptom remission at weeks 12, 24, and 52. They will also measure steroid doses, treatment continuation rates, the duration of steroid-free maintenance, and the time to achieve steroid-free status. Safety will be evaluated by recording adverse events related to the treatments. Participation involves regular observation and data collection over one year.

CONDITIONS

Brief Title

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Participants with ulcerative colitis who have provided written consent to participate
Participants aged 18 years or older at the earlier date of either starting ozanimod or azathioprine or obtaining consent
Starting oral steroid dose of 30 mg/day or higher (prednisolone equivalent)
Started ozanimod or azathioprine after beginning oral steroid treatment and took them alongside steroids (not on the same day)
In the ozanimod group, patients had notable clinical symptoms at the start of ozanimod treatment (rectal bleeding subscore 1 or higher or total PRO2 score 2 or higher)
In the azathioprine group, patients started azathioprine treatment after February 2019

You will not qualify if you...

Patients whose symptoms did not improve or worsened after 2 weeks of oral steroids at 30 mg/day or higher
Patients with complications requiring ongoing steroid use (except inhaled or topical steroids)
Patients who participated in other clinical studies with treatments during the observation period
Patients deemed inappropriate for enrollment by the investigator at each study site

Research Team

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

First line of the email MUST contain NCT # and Site #.

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Real-world Study Comparing Ozanimod and Azathioprine for Treating Steroid-Dependent Ulcerative Colitis in Adults in Japan

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria