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Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis | Clinical Trials | Clareo Health

RECRUITING

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

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

NCT07271069•Bristol-Myers Squibb

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (17)

Chiba University

Chiba, Chiba, Japan

Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Chiba, Japan

Toho University Sakura Hospital

Sakura, Chiba, Japan

Ehime Prefectural Central Hospital

Matsuyama, Ehime, Japan

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan

Fukuoka University Chikushi Hospital

Fukuoka, Fukuoka, Japan

Asahikawa Medical University

Asahikawa, Hokkaido, Japan

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan

Hyogo Medical University

Nishinomiya, Hyōgo, Japan

Kagawa Prefectural Central Hospital

Takamatsu, Kagawa-ken, Japan

Key Dates

Start Date

January 29, 2026

Primary Completion Date

March 31, 2027

Completion Date

December 31, 2027

Last Updated

March 13, 2026

Enrollment

150

ESTIMATED participants

Conditions

Ulcerative Colitis (UC)

Interventions

Ozanimod

DRUG

Azathioprine

DRUG

Contacts

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

855-907-3286 Clinical.Trials@bms.com

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

CONTACT

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: March 13, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Inclusion Criteria

Exclusion Criteria

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