Ignite Creation Date:
2025-12-24 @ 4:36 PM
Ignite Modification Date:
2025-12-25 @ 2:27 PM
Study NCT ID:
NCT04852666
Status:
COMPLETED
Last Update Posted:
2024-06-14
First Post:
2021-04-16
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], 'ancestors': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'michael_kappelman@med.unc.edu', 'phone': '919-843-5908', 'title': 'Michael Kappelman, MD, MPH', 'organization': 'University of North Carolina at Chapel Hill'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': 'Adverse Events were not collected.', 'description': 'This was an observational study and not designed to assess adverse events; therefore, safety reporting was not applicable for this study.', 'eventGroups': [{'id': 'EG000', 'title': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab.", 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'PROMIS Measures of Pain Interference', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab."}, {'id': 'OG001', 'title': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab."}, {'id': 'OG002', 'title': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.'}, {'id': 'OG003', 'title': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '51.2', 'spread': '10.17', 'groupId': 'OG000'}, {'value': '51.6', 'spread': '9.94', 'groupId': 'OG001'}, {'value': '50.1', 'spread': '10.2', 'groupId': 'OG002'}, {'value': '48.2', 'spread': '9.0', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.751', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.372', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)', 'description': 'NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health).', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'PROMIS Measures of Fatigue', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab."}, {'id': 'OG001', 'title': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab."}, {'id': 'OG002', 'title': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.'}, {'id': 'OG003', 'title': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '54.7', 'spread': '11.73', 'groupId': 'OG000'}, {'value': '54.4', 'spread': '12.31', 'groupId': 'OG001'}, {'value': '52.7', 'spread': '11.8', 'groupId': 'OG002'}, {'value': '50.6', 'spread': '9.4', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.778', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.357', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)', 'description': 'NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Fatigue. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more fatigue (poorer health).', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Index Medication Persistence', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab."}, {'id': 'OG001', 'title': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab."}, {'id': 'OG002', 'title': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.'}, {'id': 'OG003', 'title': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '119', 'groupId': 'OG000'}, {'value': '203', 'groupId': 'OG001'}, {'value': '63', 'groupId': 'OG002'}, {'value': '29', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.012', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.956', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-10 months after medication initiation', 'description': 'Medication persistence was defined as continuing index medication.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants Using Corticosteroids at Follow-Up', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '71', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab."}, {'id': 'OG001', 'title': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab."}, {'id': 'OG002', 'title': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.'}, {'id': 'OG003', 'title': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '27', 'groupId': 'OG000'}, {'value': '28', 'groupId': 'OG001'}, {'value': '15', 'groupId': 'OG002'}, {'value': '1', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.103', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.025', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 'Chi-squared', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': '4-10 months after medication initiation', 'description': 'Participants who reported using corticosteroids.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'All available data are reported.'}, {'type': 'SECONDARY', 'title': "Short Crohn's Disease Activity Index (sCDAI)", 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab."}, {'id': 'OG001', 'title': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab."}, {'id': 'OG002', 'title': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.'}, {'id': 'OG003', 'title': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '147', 'spread': '89.6', 'groupId': 'OG000'}, {'value': '144', 'spread': '85.8', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.785', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)', 'description': "Short Crohn's Disease Activity Index. This is a method to measure Crohn's disease patients' symptoms using only a questionnaire, which can be completed without an office visit or lab work. The variables included in the short CDAI are abdominal pain, stool frequency, and general well-being reported as a total score. The higher the score, the worse the disease activity. The sCDAI uses the same scale as the full CDAI with scores ranging from 0 to 600, such that scores,\\<150 define remission, 150 to 219 mild activity, 220 to 450 moderate activity, and greater than 450 severe activity.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "This outcome applies only to those participants who have Crohn's disease."}, {'type': 'SECONDARY', 'title': 'Mayo Clinic Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '69', 'groupId': 'OG002'}, {'value': '30', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab."}, {'id': 'OG001', 'title': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab."}, {'id': 'OG002', 'title': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.'}, {'id': 'OG003', 'title': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '1.7', 'spread': '1.8', 'groupId': 'OG002'}, {'value': '1.2', 'spread': '1.5', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.200', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)', 'description': 'The Mayo Clinic Score (MCS) asks 2 questions about (1) stool frequency and (2) rectal bleeding with an overall score range (0-6). Higher scores reflect more disease symptomatology.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'This outcome applies only to those participants who have ulcerative colitis. All available data are reported.'}, {'type': 'SECONDARY', 'title': 'PROMIS Social Satisfaction Score', 'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}, {'value': '72', 'groupId': 'OG002'}, {'value': '33', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab."}, {'id': 'OG001', 'title': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab."}, {'id': 'OG002', 'title': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.'}, {'id': 'OG003', 'title': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.'}], 'classes': [{'categories': [{'measurements': [{'value': '49.1', 'spread': '10.59', 'groupId': 'OG000'}, {'value': '49.3', 'spread': '10.06', 'groupId': 'OG001'}, {'value': '47.5', 'spread': '11.0', 'groupId': 'OG002'}, {'value': '50.4', 'spread': '10.6', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.887', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}, {'pValue': '0.204', 'groupIds': ['OG002', 'OG003'], 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)', 'description': 'NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of social satisfaction. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score for social satisfaction indicates better health.', 'unitOfMeasure': 'T-score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab."}, {'id': 'FG001', 'title': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab."}, {'id': 'FG002', 'title': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.'}, {'id': 'FG003', 'title': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '219'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '141'}, {'groupId': 'FG001', 'numSubjects': '219'}, {'groupId': 'FG002', 'numSubjects': '72'}, {'groupId': 'FG003', 'numSubjects': '33'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '141', 'groupId': 'BG000'}, {'value': '219', 'groupId': 'BG001'}, {'value': '72', 'groupId': 'BG002'}, {'value': '33', 'groupId': 'BG003'}, {'value': '465', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab."}, {'id': 'BG001', 'title': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab."}, {'id': 'BG002', 'title': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.'}, {'id': 'BG003', 'title': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44', 'groupId': 'BG000', 'lowerLimit': '21', 'upperLimit': '78'}, {'value': '45', 'groupId': 'BG001', 'lowerLimit': '18', 'upperLimit': '79'}, {'value': '42.5', 'groupId': 'BG002', 'lowerLimit': '19', 'upperLimit': '75'}, {'value': '38', 'groupId': 'BG003', 'lowerLimit': '19', 'upperLimit': '74'}, {'value': '42', 'groupId': 'BG004', 'lowerLimit': '18', 'upperLimit': '79'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Female', 'categories': [{'measurements': [{'value': '100', 'groupId': 'BG000'}, {'value': '167', 'groupId': 'BG001'}, {'value': '48', 'groupId': 'BG002'}, {'value': '17', 'groupId': 'BG003'}, {'value': '332', 'groupId': 'BG004'}]}]}, {'title': 'Male', 'categories': [{'measurements': [{'value': '41', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '127', 'groupId': 'BG004'}]}]}, {'title': 'Data unavailable', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '6', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White Non-Hispanic', 'categories': [{'measurements': [{'value': '129', 'groupId': 'BG000'}, {'value': '193', 'groupId': 'BG001'}, {'value': '57', 'groupId': 'BG002'}, {'value': '28', 'groupId': 'BG003'}, {'value': '407', 'groupId': 'BG004'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '8', 'groupId': 'BG004'}]}]}, {'title': 'Hispanic', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Other or Unknown', 'categories': [{'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '43', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-05-01', 'size': 885326, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-02-17T15:53', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 465}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-01', 'completionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-01-04', 'studyFirstSubmitDate': '2021-04-16', 'resultsFirstSubmitDate': '2023-03-22', 'studyFirstSubmitQcDate': '2021-04-16', 'lastUpdatePostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-01-04', 'studyFirstPostDateStruct': {'date': '2021-04-21', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-12-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PROMIS Measures of Pain Interference', 'timeFrame': 'Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)', 'description': 'NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Pain Interference. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more pain interference (poorer health).'}, {'measure': 'PROMIS Measures of Fatigue', 'timeFrame': 'Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)', 'description': 'NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of Fatigue. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score indicates more fatigue (poorer health).'}], 'secondaryOutcomes': [{'measure': 'Number of Participants With Index Medication Persistence', 'timeFrame': '4-10 months after medication initiation', 'description': 'Medication persistence was defined as continuing index medication.'}, {'measure': 'Number of Participants Using Corticosteroids at Follow-Up', 'timeFrame': '4-10 months after medication initiation', 'description': 'Participants who reported using corticosteroids.'}, {'measure': "Short Crohn's Disease Activity Index (sCDAI)", 'timeFrame': 'Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)', 'description': "Short Crohn's Disease Activity Index. This is a method to measure Crohn's disease patients' symptoms using only a questionnaire, which can be completed without an office visit or lab work. The variables included in the short CDAI are abdominal pain, stool frequency, and general well-being reported as a total score. The higher the score, the worse the disease activity. The sCDAI uses the same scale as the full CDAI with scores ranging from 0 to 600, such that scores,\\<150 define remission, 150 to 219 mild activity, 220 to 450 moderate activity, and greater than 450 severe activity."}, {'measure': 'Mayo Clinic Score', 'timeFrame': 'Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)', 'description': 'The Mayo Clinic Score (MCS) asks 2 questions about (1) stool frequency and (2) rectal bleeding with an overall score range (0-6). Higher scores reflect more disease symptomatology.'}, {'measure': 'PROMIS Social Satisfaction Score', 'timeFrame': 'Single assessment, performed as close to 6 months after medication initiation as possible (4-10 month window)', 'description': 'NIH Patient Reported Outcome Measurement Information System (PROMIS) measures of social satisfaction. PROMIS scores can range from 0 to 100; scales are calibrated using a T-score metric with a mean of 50 and standard deviation of 10. A higher score for social satisfaction indicates better health.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Crohn's Disease", 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': "The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor necrosis factor (TNF) medications, using data from two existing cohorts.", 'detailedDescription': 'This study is a secondary analysis using data from participants in the IBD Partners and SPARC-IBD cohorts. Data received from IBD Partners consists of patient-reported outcomes gathered via online surveys (baseline and 6-month follow-ups). Data received from SPARC-IBD consists of patient-reported outcomes gathered via surveys (baseline and follow-ups) as well as data from clinical records.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Population: participants in IBD Partners or SPARC cohort.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age greater than or equal to 18;\n* diagnosis of CD or UC (as reported by participant for IBD Partners registry and/or physician for SPARC-IBD cohort);\n* initiated vedolizumab or ustekinumab for CD, or initiated vedolizumab or tofacitinib for UC; treated with anti-TNF prior to vedolizumab/ustekinumab/tofacitinib.\n\nExclusion Criteria:\n\n* less than 18 years of age'}, 'identificationModule': {'nctId': 'NCT04852666', 'acronym': 'COMPARE', 'briefTitle': 'Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)', 'organization': {'class': 'OTHER', 'fullName': 'University of North Carolina, Chapel Hill'}, 'officialTitle': "Comparative Effectiveness of Biologics or Small Molecule Therapies After Failure of Anti-TNF Treatment in Patients With Crohn's Disease and Ulcerative Colitis", 'orgStudyIdInfo': {'id': '19-0273'}, 'secondaryIdInfos': [{'id': 'PaCR-2017C2-8172-IC', 'type': 'OTHER_GRANT', 'domain': 'Patient-Centered Outcomes Research Institute (PCORI)'}]}, 'armsInterventionsModule': {'armGroups': [{'label': "Crohn's Disease (Vedolizumab)", 'description': "Participants with Crohn's disease (CD) who reported taking vedolizumab."}, {'label': "Crohn's Disease (Ustekinumab)", 'description': "Participants with Crohn's disease (CD) who reported taking ustekinumab."}, {'label': 'Ulcerative Colitis (Vedolizumab)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking vedolizumab.'}, {'label': 'Ulcerative Colitis (Tofacitinib)', 'description': 'Participants with Ulcerative colitis (UC) who reported taking tofacitinib.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10017', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Crohn's & Colitis Foundation", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '27599-7555', 'city': 'Chapel Hill', 'state': 'North Carolina', 'country': 'United States', 'facility': 'University of North Carolina', 'geoPoint': {'lat': 35.9132, 'lon': -79.05584}}], 'overallOfficials': [{'name': 'Michael Kappelman, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of North Carolina, Chapel Hill'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of North Carolina, Chapel Hill', 'class': 'OTHER'}, 'collaborators': [{'name': 'Patient-Centered Outcomes Research Institute', 'class': 'OTHER'}, {'name': "Crohn's and Colitis Foundation", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}