Ulcerative Colitis Clinical Trials

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

Status: Recruiting
Location: See all (17) locations...
Intervention Type: Drug
Study Type: Observational
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Japan
Asahikawa Medical University
RECRUITING
Asahikawa
Chiba University
RECRUITING
Chiba
Fukuoka University Chikushi Hospital
NOT_YET_RECRUITING
Chikushino-shi
Fukuoka University Chikushi Hospital
RECRUITING
Fukuoka
Hamamatsu University School of Medicine
RECRUITING
Hamamatsu
Saitama Medical Center, Saitama Medical University
RECRUITING
Hidaka-shi
Kansai Medical University
RECRUITING
Hirakata
Sapporo Medical University School of Medicine
RECRUITING
Hokkaidō
Tsujinaka Hospital Kashiwanoha
RECRUITING
Kashiwa-shi
Ehime Prefectural Central Hospital
NOT_YET_RECRUITING
Matsuyama
Kyorin University School of Medicine
RECRUITING
Mitaka-shi
Hyogo Medical University
RECRUITING
Nishinomiya
Saga University
NOT_YET_RECRUITING
Saga
Toho University Sakura Hospital
RECRUITING
Sakura
Sapporo Higashi Tokushukai Hospital
RECRUITING
Sapporo
Kagawa Prefectural Central Hospital
NOT_YET_RECRUITING
Takamatsu
Tottori University
NOT_YET_RECRUITING
Tottori-shi
Contact Information
Primary
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
Clinical.Trials@bms.com
855-907-3286
Backup
First line of the email MUST contain NCT # and Site #.
Time Frame
Start Date: 2026-01-29
Estimated Completion Date: 2027-12-31
Participants
Target number of participants: 150
Treatments
Group 1
Participants with ulcerative colitis receiving ozanimod
Group 2
Participants with ulcerative colitis receiving azathioprine
Sponsors
Leads: Bristol-Myers Squibb

This content was sourced from clinicaltrials.gov