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Recruiting NCT07271069

Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

— Observational Ulcerative Colitis (UC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Ozanimod, Azathioprine.
Who it may be relevant to
Registry conditions: Ulcerative Colitis (UC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Japan
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

Real-world Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis: A Chart Review Study

Overview

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

  • Drug Ozanimod
    According to the product label
  • Drug Azathioprine
    According to the product label

Primary outcome measures

  • Proportion of participants achieving steroid-free symptomatic remission [Time frame: Week 12; Weeks 24 and 52]
Secondary outcome measures (5)
  • Oral steroid dose prescribed [Time frame: Week 12; Weeks 24 and 52]
  • Proportion of patients with continuation of ozanimod or azathioprine treatment after oral steroid treatment initiation [Time frame: Weeks 24 and 52]
  • Steroid-free maintenance period duration [Time frame: Up to Week 52]
  • Time to achieving steroid-free status [Time frame: Up to Week 52]
  • Incidence of adverse events (AEs) and treatment-related adverse events (TRAEs) [Time frame: Up to Week 52]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

Japan · 18 centers
  • Chiba University — Chiba
  • Tsujinaka Hospital Kashiwanoha — Kashiwa-shi
  • Toho University Sakura Hospital — Sakura
  • Ehime Prefectural Central Hospital — Matsuyama
  • Fukuoka University Chikushi Hospital — Chikushino-shi
  • Fukuoka University Chikushi Hospital — Fukuoka
  • Asahikawa Medical University — Asahikawa
  • Sapporo Higashi Tokushukai Hospital — Sapporo
  • … and 10 more centers

Identifiers

NCT: NCT07271069 · IM047-1120

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗