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
- Ages 18 and older
- Any sex
Some of the main requirements, copied from the record:
- 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)
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
- About 150 participants are expected to take part.
- Start date: 2026-01-29.
- Main results expected around 2027-03-31 (estimate from the record).
- 18 study sites listed (13 marked recruiting) in Japan.
Main thing being measured
- Proportion of participants achieving steroid-free symptomatic remission (Week 12; Weeks 24 and 52)
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
- Am I likely to qualify, given my health history?
- What would I have to do, and how often would I need to visit?
- Could I get a placebo? What happens to my current treatment?
- What are the possible risks and benefits?
- Are travel or other costs covered?
- What happens after the trial ends?
Official details
| Status | Recruiting |
|---|---|
| Phase | Observational |
| Study type | Observational |
| Conditions | Ulcerative Colitis (UC) |
| Lead sponsor | Bristol-Myers Squibb |
| Enrollment | 150 (estimated) |
| Start date | 2026-01-29 |
| Primary completion (est.) | 2027-03-31 |
| First posted | 2025-12-08 |
| Last updated | 2026-05-18 |
| Official title | Real-world Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis: A Chart Review Study |
| ClinicalTrials.gov ID | NCT07271069 |
Interventions
- Ozanimod (Drug)
According to the product label - Azathioprine (Drug)
According to the product label
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)
| Site | City | Country | Site status |
|---|---|---|---|
| Sapporo Medical University School of Medicine | Hokkaidō | Japan | Recruiting |
| Chiba University | Chiba, Chiba | Japan | Recruiting |
| Tsujinaka Hospital Kashiwanoha | Kashiwa-shi, Chiba | Japan | Recruiting |
| Toho University Sakura Hospital | Sakura, Chiba | Japan | Recruiting |
| Ehime Prefectural Central Hospital | Matsuyama, Ehime | Japan | Not yet recruiting |
| Fukuoka University Chikushi Hospital | Chikushino-shi, Fukuoka | Japan | Not yet recruiting |
| Fukuoka University Chikushi Hospital | Fukuoka, Fukuoka | Japan | Recruiting |
| Asahikawa Medical University | Asahikawa, Hokkaido | Japan | Recruiting |
| Sapporo Higashi Tokushukai Hospital | Sapporo, Hokkaido | Japan | Recruiting |
| Hyogo Medical University | Nishinomiya, Hyōgo | Japan | Recruiting |
| Kagawa Prefectural Central Hospital | Takamatsu, Kagawa-ken | Japan | Not yet recruiting |
| Kansai Medical University | Hirakata, Osaka | Japan | Recruiting |
| Saga University | Saga, Saga-ken | Japan | Not yet recruiting |
| Saitama Medical Center, Saitama Medical University | Hidaka-shi, Saitama | Japan | Recruiting |
| Hamamatsu University School of Medicine | Hamamatsu, Shizuoka | Japan | Recruiting |
| Mebix. Inc. | Minato-ku, Tokyo | Japan | Recruiting |
| Kyorin University School of Medicine | Mitaka-shi, Tokyo | Japan | Recruiting |
| Tottori University | Tottori-shi, Tottori | Japan | Not 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.