Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis
ConditionUlcerative Colitis (UC)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorBristol-Myers Squibb
About this trial
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 criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Ozanimod
- Azathioprine
Treatment groups
150 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov