Ulcerative Colitis (UC)
Conditions
Keywords
Ulcerative Colitis (UC)
Brief 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
Interventions
DRUGOzanimod
According to the product label
DRUGAzathioprine
According to the product label
Sponsors
Bristol-Myers Squibb
Study design
Observational model
COHORT
Time perspective
RETROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of participants achieving steroid-free symptomatic remission | Week 12; Weeks 24 and 52 |
Secondary
| Measure | Time frame |
|---|---|
| Oral steroid dose prescribed | Week 12; Weeks 24 and 52 |
| Proportion of patients with continuation of ozanimod or azathioprine treatment after oral steroid treatment initiation | Weeks 24 and 52 |
| Steroid-free maintenance period duration | Up to Week 52 |
| Time to achieving steroid-free status | Up to Week 52 |
| Incidence of adverse events (AEs) and treatment-related adverse events (TRAEs) | Up to Week 52 |
Countries
Japan
Contacts
CONTACTBMS Clinical Trials Contact Center www.BMSClinicalTrials.com
CONTACTFirst line of the email MUST contain NCT # and Site #.
STUDY_DIRECTORBristol Myers Squibb
Bristol-Myers Squibb
Outcome results
None listed