Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis
Recruiting · NCT07271069 · Observational (researchers observe without assigning treatment) · Lead sponsor: Bristol-Myers Squibb
View the official record on ClinicalTrials.gov →Interventions studied
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
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not specified
Study type
Observational (researchers observe without assigning treatment)
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
Where it is running
18 locations listed.
- Sapporo Medical University School of Medicine - Hokkaidō, Japan
- Chiba University - Chiba, Chiba, Japan
- Tsujinaka Hospital Kashiwanoha - Kashiwa-shi, Chiba, Japan
- Toho University Sakura Hospital - Sakura, Chiba, Japan
- Ehime Prefectural Central Hospital - Matsuyama, Ehime, Japan
- Fukuoka University Chikushi Hospital - Chikushino-shi, Fukuoka, Japan
- Fukuoka University Chikushi Hospital - Fukuoka, Fukuoka, Japan
- Asahikawa Medical University - Asahikawa, Hokkaido, Japan
- Sapporo Higashi Tokushukai Hospital - Sapporo, Hokkaido, Japan
- Hyogo Medical University - Nishinomiya, Hyōgo, Japan
- Kagawa Prefectural Central Hospital - Takamatsu, Kagawa-ken, Japan
- Kansai Medical University - Hirakata, Osaka, Japan
- Saga University - Saga, Saga-ken, Japan
- Saitama Medical Center, Saitama Medical University - Hidaka-shi, Saitama, Japan
- Hamamatsu University School of Medicine - Hamamatsu, Shizuoka, Japan
- Mebix. Inc. - Minato-ku, Tokyo, Japan
- Kyorin University School of Medicine - Mitaka-shi, Tokyo, Japan
- Tottori University - Tottori-shi, Tottori, Japan