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Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis

Recruitingn/aAges 18 Years - anyAllBristol-Myers Squibb
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Ozanimod
  • Azathioprine
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Where

18 sites
Chiba University
Chiba, Japan
Tsujinaka Hospital Kashiwanoha
Kashiwa-shi, Japan
Toho University Sakura Hospital
Sakura, Japan
Ehime Prefectural Central Hospital
Matsuyama, Japan
Fukuoka University Chikushi Hospital
Chikushino-shi, Japan
Fukuoka University Chikushi Hospital
Fukuoka, Japan
Asahikawa Medical University
Asahikawa, Japan
Sapporo Higashi Tokushukai Hospital
Sapporo, Japan

…and 10 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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