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NCT Number: NCT07271069

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

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

Recruiting

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Chiba University, Chiba, Japan

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ozanimod

Drug

According to the product label

azathioprine

Drug

According to the product label

Primary outcomes

  1. Proportion of participants achieving steroid-free symptomatic remission

    Time frame: Week 12; Weeks 24 and 52

Secondary outcomes

  1. Oral steroid dose prescribed

    Time frame: Week 12; Weeks 24 and 52

  2. Proportion of patients with continuation of ozanimod or azathioprine treatment after oral steroid treatment initiation

    Time frame: Weeks 24 and 52

  3. Steroid-free maintenance period duration

    Time frame: Up to Week 52

  4. Time to achieving steroid-free status

    Time frame: Up to Week 52

  5. Incidence of adverse events (AEs) and treatment-related adverse events (TRAEs)

    Time frame: Up to Week 52

Study contacts

Contact information is provided by the study sponsor or research team.

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

[email protected]

855-907-3286

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

CONTACT

Sponsors and collaborators

Lead sponsor

Bristol-Myers Squibb

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Dec 8, 2025
Registry last updated
May 18, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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