Ignite Creation Date:
2025-12-24 @ 10:46 PM
Ignite Modification Date:
2025-12-25 @ 8:16 PM
Study NCT ID:
NCT07271069
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-08
First Post:
2025-11-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D003092', 'term': 'Colitis'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003108', 'term': 'Colonic Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000607776', 'term': 'ozanimod'}, {'id': 'D001379', 'term': 'Azathioprine'}], 'ancestors': [{'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 150}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-28', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-11', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-11-27', 'studyFirstSubmitDate': '2025-11-27', 'studyFirstSubmitQcDate': '2025-11-27', 'lastUpdatePostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-08', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2027-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of participants achieving steroid-free symptomatic remission', 'timeFrame': 'Week 12; Weeks 24 and 52'}], 'secondaryOutcomes': [{'measure': 'Oral steroid dose prescribed', 'timeFrame': 'Week 12; Weeks 24 and 52'}, {'measure': 'Proportion of patients with continuation of ozanimod or azathioprine treatment after oral steroid treatment initiation', 'timeFrame': 'Weeks 24 and 52'}, {'measure': 'Steroid-free maintenance period duration', 'timeFrame': 'Up to Week 52'}, {'measure': 'Time to achieving steroid-free status', 'timeFrame': 'Up to Week 52'}, {'measure': 'Incidence of adverse events (AEs) and treatment-related adverse events (TRAEs)', 'timeFrame': 'Up to Week 52'}]}, 'oversightModule': {'isUsExport': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Ulcerative Colitis (UC)'], 'conditions': ['Ulcerative Colitis (UC)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.bms.com/researchers-and-partners/clinical-trials-and-research.html', 'label': 'BMS Clinical Trial Information'}, {'url': 'https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts', 'label': 'FDA Safety Alerts and Recalls'}]}, 'descriptionModule': {'briefSummary': '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'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants with Ulcerative Colitis (UC) provided written consent to participate in the study\n* Participants who are aged ≥ 18 years at the earlier date of either initiation of treatment with ozanimod or azathioprine or obtaining consent\n* Starting dose of oral steroid ≥ 30 mg/day (prednisolone equivalent)\n* 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)\n* 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\n* In the azathioprine group, patients who started azathioprine treatment after February 2019\n\nExclusion Criteria:\n\n* 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\n* Participants with complications requiring continued steroid use (excluding topically acting steroids for inhalation or topical application)\n* Participants who participated in other clinical studies involving interventions during the observation period\n* Participants judged to be inappropriate for enrollment in this study by the investigator at each participating study site'}, 'identificationModule': {'nctId': 'NCT07271069', 'briefTitle': 'Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bristol-Myers Squibb'}, 'officialTitle': 'Real-world Effectiveness of Ozanimod in Patients With Steroid-Dependent Ulcerative Colitis: A Chart Review Study', 'orgStudyIdInfo': {'id': 'IM047-1120'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Group 1', 'description': 'Participants with ulcerative colitis receiving ozanimod', 'interventionNames': ['Drug: Ozanimod']}, {'label': 'Group 2', 'description': 'Participants with ulcerative colitis receiving azathioprine', 'interventionNames': ['Drug: Azathioprine']}], 'interventions': [{'name': 'Ozanimod', 'type': 'DRUG', 'description': 'According to the product label', 'armGroupLabels': ['Group 1']}, {'name': 'Azathioprine', 'type': 'DRUG', 'description': 'According to the product label', 'armGroupLabels': ['Group 2']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Hokkaidō', 'country': 'Japan', 'facility': 'Sapporo Medical university school of Medicine'}], 'centralContacts': [{'name': 'BMS Study Connect Contact Center www.BMSStudyConnect.com', 'role': 'CONTACT', 'email': 'Clinical.Trials@bms.com', 'phone': '855-907-3286'}, {'name': 'First line of the email MUST contain NCT # and Site #.', 'role': 'CONTACT'}], 'overallOfficials': [{'name': 'Bristol Myers Squibb', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Bristol-Myers Squibb'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bristol-Myers Squibb', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}