ulcerative colitis
Conditions
Interventions
None listed
Sponsors
Kamiya Yoshiaki
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1.Patients with UC provided written consent to participate in the study 2.Patients who are aged >= 18 years at the earlier date of either initiation of treatment with ozanimod or azathioprine or obtaining consent 3.Starting dose of oral steroid >= 30 mg/day (prednisolone equivalent) 4.Administration of ozanimod or azathioprine started after oral steroid administration, and ozanimod or azathioprine administered concomitantly with oral steroids (excluding patients who started oral steroids and ozanimod or azathioprine on the same day) 5.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 6.In the azathioprine group, patients who started azathioprine treatment after February 2019
Exclusion criteria
Exclusion criteria: 1.Patients 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 2.Patients with complications requiring continued steroid use (excluding topically acting steroids for inhalation or topical application) 3.Patients who participated in other clinical studies involving interventions during the observation period 4.Patients 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 patients achieving steroid-free symptomatic remission at Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| -Proportions of patients achieving steroid-free symptomatic remission at Weeks 24 and 52 Steroid-free symptomatic remission at Week 24 and 52 is defined in Section 3.4.1. The same analysis will be performed as for the primary endpoint. -Steroid-free maintenance period Steroid-free maintenance period is defined in Section 3.4.1. The Kaplan-Meier method will be used to estimate the cumulative percentage of steroid-free patients and the median duration of steroid-free status, and the 95% CI for the median duration of steroid-free status will be calculated and compared between the groups. -Oral steroid doses at Weeks 12, 24, and 52 Oral steroid dose is defined in Section 3.4.1. Summary statistics of oral steroid doses at each time point will be calculated and compared between groups. The percentage of patients in each category (prednisolone equivalent) will also be calculated and compared between the groups. -Time to steroid-free status Steroid-free status is defined in Section 3.4.1. Summary statistics for the time from the start of oral steroid treatment for UC to the first steroid-free date in patients who reach steroid-free status will be calculated and compared between the groups. The Kaplan-Meier method will be used to estimate the cumulative percentage of steroid-free patients and the median time to steroid-free status, and the 95% CI for the median time to steroid-free status will be calculated and compared between the groups. -Proportions of patients with continuation of ozanimod or azathioprine treatment at Weeks 24 and 52 The proportion of patients with continuation of ozanimod or azathioprine treatment is defined in Section 3.4.1. The proportion of eligible patients with continuation of ozanimod or azathioprine treatment will be calculated using the following formula. A between-group comparison of the proportion of patients with continuation of ozanimod or azathioprine treatment will also be performed. Proportion of patients with continuation ozanimod or aza | — |
Contacts
Public ContactAn Ito
Mebix,inc
Outcome results
None listed