Ozanimod versus azathioprine for steroid-dependent ulcerative colitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Chiba University
  Chiba, Chiba, Japan Recruiting
• Tsujinaka Hospital Kashiwanoha
  Kashiwa-shi, Chiba, Japan Recruiting
• Toho University Sakura Hospital
  Sakura, Chiba, Japan Recruiting
• Fukuoka University Chikushi Hospital
  Fukuoka, Fukuoka, Japan Recruiting
• Asahikawa Medical University
  Asahikawa, Hokkaido, Japan Recruiting
• Sapporo Higashi Tokushukai Hospital
  Sapporo, Hokkaido, Japan Recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.