Ozanimod versus azathioprine for steroid-dependent ulcerative colitis

Real-world Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis: A Chart Review Study

This study will see if ozanimod works better than azathioprine for adults in Japan who are dependent on high-dose steroids for ulcerative colitis.

Quick facts

• Study type: Observational
• Enrollment: 150 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Bristol-Myers Squibb (Industry-sponsored)
• Locations: 17 sites (Chiba, Chiba and 16 other locations)
• Trial ID: NCT07271069 on ClinicalTrials.gov

What this trial studies

This observational study follows adults with steroid-dependent ulcerative colitis in routine clinical practice in Japan who start either ozanimod or azathioprine after beginning high-dose oral steroids. Eligible patients must have started steroids at or above 30 mg/day (prednisolone equivalent) and begin the chosen therapy while still on steroids, with additional symptom criteria for the ozanimod group and a calendar restriction for the azathioprine group. Investigators will collect clinical symptom scores, safety events, and treatment outcomes from participating hospitals to compare effectiveness and tolerability between the two treatments. Because treatment choice is determined by clinicians rather than random assignment, analyses will use real-world comparative methods to account for baseline differences.

Who should consider this trial

Good fit: Adults (≥18) with ulcerative colitis in Japan who started oral steroids at ≥30 mg/day and then began ozanimod or azathioprine while still on steroids—ozanimod patients must have ongoing rectal bleeding or a PRO2 score ≥2 at treatment start, and azathioprine users must have started after February 2019.

Not a fit: Patients who are steroid-independent, who started steroids and ozanimod or azathioprine on the same day, who are under 18, or who are not treated at participating Japanese centers are unlikely to be eligible or benefit from this study's findings.

Why it matters

Potential benefit: If successful, this comparison could identify which oral option better controls symptoms and helps reduce steroid use with fewer safety issues.

How similar studies have performed: Randomized trials have demonstrated ozanimod's efficacy in ulcerative colitis, but direct real-world head-to-head comparisons with azathioprine are limited.

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

Where this trial is running

Chiba, Chiba and 16 other locations

• Chiba University — Chiba, Chiba, Japan (Recruiting)
• Tsujinaka Hospital Kashiwanoha — Kashiwa-shi, Chiba, Japan (Recruiting)
• Toho University Sakura Hospital — Sakura, Chiba, Japan (Recruiting)
• Ehime Prefectural Central Hospital — Matsuyama, Ehime, Japan (Not_yet_recruiting)
• Fukuoka University Chikushi Hospital — Chikushino-shi, Fukuoka, Japan (Not_yet_recruiting)
• Fukuoka University Chikushi Hospital — Fukuoka, Fukuoka, Japan (Recruiting)
• Asahikawa Medical University — Asahikawa, Hokkaido, Japan (Recruiting)
• Sapporo Higashi Tokushukai Hospital — Sapporo, Hokkaido, Japan (Recruiting)
• Hyogo Medical University — Nishinomiya, Hyōgo, Japan (Recruiting)
• Kagawa Prefectural Central Hospital — Takamatsu, Kagawa-ken, Japan (Not_yet_recruiting)
• Kansai Medical University — Hirakata, Osaka, Japan (Recruiting)
• Saga University — Saga, Saga-ken, Japan (Not_yet_recruiting)
• Saitama Medical Center, Saitama Medical University — Hidaka-shi, Saitama, Japan (Recruiting)
• Hamamatsu University School of Medicine — Hamamatsu, Shizuoka, Japan (Recruiting)
• Kyorin University School of Medicine — Mitaka-shi, Tokyo, Japan (Recruiting)
• Tottori University — Tottori-shi, Tottori, Japan (Not_yet_recruiting)
• Sapporo Medical University School of Medicine — Hokkaidō, Japan (Recruiting)

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

Conditions Ulcerative Colitis