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UCRecruiting

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Observational · No treatment assigned · 18 sites · Bristol-Myers Squibb

Official record & contacts on ClinicalTrials.gov ↗

In plain English

What this trial is testing

Condition(s) listed: Ulcerative Colitis (UC). This is an observational study: researchers collect information (for example questionnaires, samples, or scans) but the study does not assign a treatment.

Who can join

Some of the main requirements, copied from the record:

Plus 3 more requirement(s). There are also 4 reasons someone might not be able to join (exclusion criteria). Only the trial team can confirm whether you qualify.

What's involved

Main thing being measured

In the researchers’ words

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

This is a short automatic summary built from the official record. A fuller plain-English card is coming; until then, please read the official record.

Questions to ask your doctor and the trial team

Official details

StatusRecruiting
PhaseObservational
Study typeObservational
ConditionsUlcerative Colitis (UC)
Lead sponsorBristol-Myers Squibb
Enrollment150 (estimated)
Start date2026-01-29
Primary completion (est.)2027-03-31
First posted2025-12-08
Last updated2026-05-18
Official titleReal-world Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis: A Chart Review Study
ClinicalTrials.gov IDNCT07271069

Interventions

Full eligibility criteria (from the record)
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 (18)

SiteCityCountrySite status
Sapporo Medical University School of MedicineHokkaidōJapanRecruiting
Chiba UniversityChiba, ChibaJapanRecruiting
Tsujinaka Hospital KashiwanohaKashiwa-shi, ChibaJapanRecruiting
Toho University Sakura HospitalSakura, ChibaJapanRecruiting
Ehime Prefectural Central HospitalMatsuyama, EhimeJapanNot yet recruiting
Fukuoka University Chikushi HospitalChikushino-shi, FukuokaJapanNot yet recruiting
Fukuoka University Chikushi HospitalFukuoka, FukuokaJapanRecruiting
Asahikawa Medical UniversityAsahikawa, HokkaidoJapanRecruiting
Sapporo Higashi Tokushukai HospitalSapporo, HokkaidoJapanRecruiting
Hyogo Medical UniversityNishinomiya, HyōgoJapanRecruiting
Kagawa Prefectural Central HospitalTakamatsu, Kagawa-kenJapanNot yet recruiting
Kansai Medical UniversityHirakata, OsakaJapanRecruiting
Saga UniversitySaga, Saga-kenJapanNot yet recruiting
Saitama Medical Center, Saitama Medical UniversityHidaka-shi, SaitamaJapanRecruiting
Hamamatsu University School of MedicineHamamatsu, ShizuokaJapanRecruiting
Mebix. Inc.Minato-ku, TokyoJapanRecruiting
Kyorin University School of MedicineMitaka-shi, TokyoJapanRecruiting
Tottori UniversityTottori-shi, TottoriJapanNot yet recruiting

For contacts at each site, use the official record.

Information only, not medical advice. Talk to your doctor and the trial team before making any decision about a clinical trial.