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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Participants with ulcerative colitis receiving ozanimod |
| |
| Group 2 | Participants with ulcerative colitis receiving azathioprine |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ozanimod | Drug | According to the product label |
| |
| Azathioprine |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of participants achieving steroid-free symptomatic remission | Week 12; Weeks 24 and 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Oral steroid dose prescribed | Week 12; Weeks 24 and 52 | |
| Proportion of patients with continuation of ozanimod or azathioprine treatment after oral steroid treatment initiation | Weeks 24 and 52 | |
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Inclusion Criteria:
Exclusion Criteria:
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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
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| BMS Clinical Trials Contact Center www.BMSClinicalTrials.com | Contact | 855-907-3286 | Clinical.Trials@bms.com | |
| First line of the email MUST contain NCT # and Site #. | Contact |
| Name | Affiliation | Role |
|---|---|---|
| Bristol Myers Squibb | Bristol-Myers Squibb | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chiba University | Recruiting | Chiba | Chiba | 263-8522 | Japan | |
| Tsujinaka Hospital Kashiwanoha |
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| Label | URL |
|---|---|
| BMS Clinical Trial Information | View source |
| FDA Safety Alerts and Recalls | View source |
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| ID | Term |
|---|---|
| D003093 | Colitis, Ulcerative |
| ID | Term |
|---|---|
| D003092 | Colitis |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
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| ID | Term |
|---|---|
| C000607776 | ozanimod |
| D001379 | Azathioprine |
| ID | Term |
|---|---|
| D013872 | Thionucleosides |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D015122 | Mercaptopurine |
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| Drug |
According to the product label |
|
| Steroid-free maintenance period duration |
| Up to Week 52 |
| Time to achieving steroid-free status | Up to Week 52 |
| Incidence of adverse events (AEs) and treatment-related adverse events (TRAEs) | Up to Week 52 |
| Recruiting |
| Kashiwa-shi |
| Chiba |
| 277-0871 |
| Japan |
| Toho University Sakura Hospital | Recruiting | Sakura | Chiba | 285-8741 | Japan |
| Ehime Prefectural Central Hospital | Not yet recruiting | Matsuyama | Ehime | 790-0024 | Japan |
| Fukuoka University Chikushi Hospital | Not yet recruiting | Chikushino-shi | Fukuoka | 818-8502 | Japan |
| Fukuoka University Chikushi Hospital | Recruiting | Fukuoka | Fukuoka | 814-0180 | Japan |
| Asahikawa Medical University | Recruiting | Asahikawa | Hokkaido | 078-8510 | Japan |
| Sapporo Higashi Tokushukai Hospital | Recruiting | Sapporo | Hokkaido | 065-0033 | Japan |
| Hyogo Medical University | Recruiting | Nishinomiya | Hyōgo | 663-8501 | Japan |
| Kagawa Prefectural Central Hospital | Not yet recruiting | Takamatsu | Kagawa-ken | 760-8557 | Japan |
| Kansai Medical University | Recruiting | Hirakata | Osaka | 573-1010 | Japan |
| Saga University | Not yet recruiting | Saga | Saga-ken | 840-8502 | Japan |
| Saitama Medical Center, Saitama Medical University | Recruiting | Hidaka-shi | Saitama | 350-1298 | Japan |
| Hamamatsu University School of Medicine | Recruiting | Hamamatsu | Shizuoka | 431-3192 | Japan |
| Mebix. Inc. | Recruiting | Minato-ku | Tokyo | 1070052 | Japan |
|
| Kyorin University School of Medicine | Recruiting | Mitaka-shi | Tokyo | 181-8611 | Japan |
| Tottori University | Not yet recruiting | Tottori-shi | Tottori | 680-8550 | Japan |
| Sapporo Medical University School of Medicine | Recruiting | Hokkaidō | Japan |
| D015212 |
| Inflammatory Bowel Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D011687 |
| Purines |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |