Ignite Creation Date:
2025-12-24 @ 4:32 PM
Ignite Modification Date:
2025-12-27 @ 7:15 AM
Study NCT ID:
NCT04879966
Status:
UNKNOWN
Last Update Posted:
2022-11-25
First Post:
2021-05-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Cohort Study Comparing IFX to CS for Moderate to Severe UC
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069285', 'term': 'Infliximab'}, {'id': 'D000305', 'term': 'Adrenal Cortex Hormones'}], 'ancestors': [{'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 342}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-05-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-11', 'completionDateStruct': {'date': '2023-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-11-22', 'studyFirstSubmitDate': '2021-05-06', 'studyFirstSubmitQcDate': '2021-05-06', 'lastUpdatePostDateStruct': {'date': '2022-11-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'clinical remission', 'timeFrame': 'week 14', 'description': 'defined as a total score of ≤2 on the Mayo scale and no subscore \\>1; partial Mayo score ≤ 2, no individual subscore \\> 1'}], 'secondaryOutcomes': [{'measure': 'clinical response in induction phase', 'timeFrame': 'week 14', 'description': "defined as a reduction in the partial Mayo score \\[stool frequency, rectal bleeding, and physician's global assessment\\] of ≥2 points and of ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point"}, {'measure': 'mucosal healing in induction phase', 'timeFrame': 'week 14', 'description': 'defined as a subscore of 0 or 1 on the Mayo endoscopic component'}, {'measure': 'histological healing in induction phase', 'timeFrame': 'week 14', 'description': 'defined as Nancy index score of 0'}, {'measure': 'clinical response in maintenance phase', 'timeFrame': 'week 52', 'description': "defined as a reduction in the partial Mayo score \\[stool frequency, rectal bleeding, and physician's global assessment\\] of ≥2 points and of ≥25% from baseline, with an accompanying decrease in rectal bleeding subscore of ≥1 point or absolute rectal bleeding subscore of ≤1 point"}, {'measure': 'mucosal healing in maintenance phase', 'timeFrame': 'week 52', 'description': 'defined as a subscore of 0 or 1 on the Mayo endoscopic component'}, {'measure': 'histological healing in maintenance phase', 'timeFrame': 'week 52', 'description': 'defined as Nancy index score of 0'}, {'measure': 'quality of life in induction phase', 'timeFrame': 'week 14', 'description': 'defined as an increase of ≥16 points in IBDQ score'}, {'measure': 'quality of life in maintenance phase', 'timeFrame': 'week 52', 'description': 'defined as an increase of ≥16 points in IBDQ score'}, {'measure': 'adverse events', 'timeFrame': 'week 52', 'description': 'as assessed by the incidence of adverse events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'The first-line treatment strategy of moderate to severe UC was a important question at issue. The biological agents had potentiality to alter the disease course of UC. The AGA clinical guidelines had conditional recommend that IFX and other biological agene migtht be first-line therapy for high-risk UC patints but only had low grade evidence.We launched this multicenter prospective cohort trial to compare the efficacy and safety of infliximab (IFX) and corticosteroids(CS) when they was used as first-line therapy in UC patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Adults patinets of moderately to severely active ulcerative colitis who will initiate IFX or CS', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* moderately to severely active ulcerative colitis, defined as a total score of 6 to 12 on the Mayo scale (scores range from 0 to 12, with higher scores indicating more severe disease) and a subscore of at least 2 on the endoscopic component of the Mayo scale (subscores on each of the four components of the Mayo scale range from 0 to 3)\n* Patients who had colonic involvement of at least 15 cm\n* Patients who had a confirmed diagnosis of ulcerative colitis at least 3 months before screening and confirmed by Pathology\n\nExclusion Criteria:\n\n* Patients who had previously used any TNF inhibitor\n* Patients who were steroid-dependent or steriod-resistant\n* Patients who had undergone subtotal colectomy or total colectomy\n* Patients who had stoma'}, 'identificationModule': {'nctId': 'NCT04879966', 'acronym': 'INSURE', 'briefTitle': 'A Cohort Study Comparing IFX to CS for Moderate to Severe UC', 'organization': {'class': 'OTHER', 'fullName': 'Sixth Affiliated Hospital, Sun Yat-sen University'}, 'officialTitle': 'A Multicenter Prospective Cohort Study Comparing Infliximab to Corticosteroids for Moderate to Severe Ulcerative Colitis', 'orgStudyIdInfo': {'id': '2021ZSLYEC-102'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'UC cohort', 'description': 'the patiente of Moderate to Severe Ulcerative Colitis who recieved infliximab(IFX) or corticosteroids(CS) as induction therapy would be enrolled in this cohort', 'interventionNames': ['Drug: Infliximab', 'Drug: Corticosteroid']}], 'interventions': [{'name': 'Infliximab', 'type': 'DRUG', 'otherNames': ['IFX'], 'description': 'Infliximab was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher', 'armGroupLabels': ['UC cohort']}, {'name': 'Corticosteroid', 'type': 'DRUG', 'otherNames': ['CS'], 'description': 'Corticosteroids was used as induction therapy in UC patients, the maintenance treatment was decided by the researcher', 'armGroupLabels': ['UC cohort']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guandong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jian Tang', 'role': 'CONTACT', 'email': 'tangjiansys@163.com', 'phone': '13751879964'}], 'facility': 'The Sixth Affiliated Hospital, Sun Yat-sen University', 'geoPoint': {'lat': 32.17424, 'lon': 120.10228}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sixth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}