Actively Recruiting

Age: 18Years +
All Genders
NCT07271069

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Led by Bristol-Myers Squibb · Updated on 2026-04-13

150

Participants Needed

17

Research Sites

100 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

CONDITIONS

Official Title

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Have ulcerative colitis and have given written consent to participate
  • Are 18 years of age or older at treatment start or consent
  • Are taking an oral steroid dose of at least 30 mg/day (prednisolone equivalent)
  • Started ozanimod or azathioprine treatment after beginning oral steroid use
  • Are taking ozanimod or azathioprine alongside steroids, but not starting both on the same day
  • In the ozanimod group, have active symptoms at the start of ozanimod treatment (rectal bleeding subscore ≥1 or PRO2 score ≥2)
  • In the azathioprine group, started treatment after February 2019
Not Eligible

You will not qualify if you...

  • Have symptoms with no improvement or worsening PRO2 score after 2 weeks of oral steroid treatment at ≥30 mg/day
  • Have complications that require continued steroid use (except topical steroids for inhalation or topical use)
  • Are participating in other clinical studies with treatments during the observation period
  • Are judged by the investigator as inappropriate for enrollment

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 17 locations

1

Chiba University

Chiba, Chiba, Japan, 263-8522

Actively Recruiting

2

Tsujinaka Hospital Kashiwanoha

Kashiwa-shi, Chiba, Japan, 277-0871

Actively Recruiting

3

Toho University Sakura Hospital

Sakura, Chiba, Japan, 285-8741

Actively Recruiting

4

Ehime Prefectural Central Hospital

Matsuyama, Ehime, Japan, 790-0024

Not Yet Recruiting

5

Fukuoka University Chikushi Hospital

Chikushino-shi, Fukuoka, Japan, 818-8502

Not Yet Recruiting

6

Fukuoka University Chikushi Hospital

Fukuoka, Fukuoka, Japan, 814-0180

Actively Recruiting

7

Asahikawa Medical University

Asahikawa, Hokkaido, Japan, 078-8510

Actively Recruiting

8

Sapporo Higashi Tokushukai Hospital

Sapporo, Hokkaido, Japan, 065-0033

Actively Recruiting

9

Hyogo Medical University

Nishinomiya, Hyōgo, Japan, 663-8501

Actively Recruiting

10

Kagawa Prefectural Central Hospital

Takamatsu, Kagawa-ken, Japan, 760-8557

Not Yet Recruiting

11

Kansai Medical University

Hirakata, Osaka, Japan, 573-1010

Actively Recruiting

12

Saga University

Saga, Saga-ken, Japan, 840-8502

Not Yet Recruiting

13

Saitama Medical Center, Saitama Medical University

Hidaka-shi, Saitama, Japan, 350-1298

Actively Recruiting

14

Hamamatsu University School of Medicine

Hamamatsu, Shizuoka, Japan, 431-3192

Actively Recruiting

15

Kyorin University School of Medicine

Mitaka-shi, Tokyo, Japan, 181-8611

Actively Recruiting

16

Tottori University

Tottori-shi, Tottori, Japan, 680-8550

Not Yet Recruiting

17

Sapporo Medical University School of Medicine

Hokkaidō, Japan

Actively Recruiting

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Research Team

B

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

F

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

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis | DecenTrialz