Ireland
--:--IST
Recruiting Observational

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

NCT07271069 · tracked via the Priya Life Science Japan tracker
Phase
Observational
Started
2026-01-29
Last updated
2026-05-18

Condition(s) studied

Ulcerative Colitis (UC)

Investigational drug(s) / intervention(s)

Ozanimod →Azathioprine →

Ozanimod: According to the product label

Azathioprine: According to the product label

Study 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

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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

Primary outcome measure(s)

  • Proportion of participants achieving steroid-free symptomatic remission — Week 12; Weeks 24 and 52

Trial sites (18)

FacilityCityRegionStatus
Chiba University Chiba Chiba Recruiting
Tsujinaka Hospital Kashiwanoha Kashiwa-shi Chiba Recruiting
Toho University Sakura Hospital Sakura Chiba Recruiting
Ehime Prefectural Central Hospital Matsuyama Ehime Not Yet Recruiting
Fukuoka University Chikushi Hospital Chikushino-shi Fukuoka Not Yet Recruiting
Fukuoka University Chikushi Hospital Fukuoka Fukuoka Recruiting
Asahikawa Medical University Asahikawa Hokkaido Recruiting
Sapporo Higashi Tokushukai Hospital Sapporo Hokkaido Recruiting
Hyogo Medical University Nishinomiya Hyōgo Recruiting
Kagawa Prefectural Central Hospital Takamatsu Kagawa-ken Not Yet Recruiting
Kansai Medical University Hirakata Osaka Recruiting
Saga University Saga Saga-ken Not Yet Recruiting
Saitama Medical Center, Saitama Medical University Hidaka-shi Saitama Recruiting
Hamamatsu University School of Medicine Hamamatsu Shizuoka Recruiting
Mebix. Inc. Minato-ku Tokyo Recruiting
Kyorin University School of Medicine Mitaka-shi Tokyo Recruiting
Tottori University Tottori-shi Tottori Not Yet Recruiting
Sapporo Medical University School of Medicine Hokkaidō Japan Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07271069 on ClinicalTrials.gov ↗ ← All trials in Japan