Health TrialsbyHealthPanel

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

This trial does not accept healthy volunteers

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 population

The study population will consist of adults diagnosed with ulcerative colitis (UC) who initiated ozanimod or azathioprine treatment after starting oral steroids and concomitant-use oral steroids in Japan

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Ozanimod

    Drug

    According to the product label

  • Azathioprine

    Drug

    According to the product label

Treatment groups

150 Participants
are divided into 2 treatment groups
Group A: Group 11 intervention
Group B: Group 21 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants achieving steroid-free symptomatic remission

Time frame
Week 12; Weeks 24 and 52

Secondary outcomes

1

Oral steroid dose prescribed

Time frame
Week 12; Weeks 24 and 52
2

Proportion of patients with continuation of ozanimod or azathioprine treatment after oral steroid treatment initiation

Time frame
Weeks 24 and 52
3

Steroid-free maintenance period duration

Time frame
Up to Week 52
4

Time to achieving steroid-free status

Time frame
Up to Week 52

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bristol-Myers Squibb

Lead sponsor

Source ClinicalTrials.gov
Apply now