Ignite Creation Date:
2025-12-24 @ 4:52 PM
Ignite Modification Date:
2025-12-28 @ 6:11 PM
Study NCT ID:
NCT04304950
Status:
COMPLETED
Last Update Posted:
2023-06-27
First Post:
2019-08-06
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Chronotherapy in Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Garth_Swanson@rush.edu', 'phone': '312-563-3871', 'title': 'Dr. Garth R. Swanson', 'phoneExt': '33871', 'organization': 'Rush University Medical Center'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was a single-center study with a limited number of IBD subjects that focused on metabolite levels and not clinical efficacy. Larger multicenter studies are needed since this was a "proof of concept" pilot study. Second, the overall dose of AZA/6-MP used in this study was low. Third, the study design relied on patient compliance with medication timing and circadian rhythms were assessed only by questionnaires.'}}, 'adverseEventsModule': {'timeFrame': '1 year, 1 month', 'description': 'Participants were monitored throughout the study and an adverse events log was kept. However, there are no major risks or discomforts associated with this study. The study procedures did not involve changing the medication or the dose of the medication the participants were taking. Participants only changed the time they took their medications ( morning or evening). Questionnaires and check-in calls were used to assess for any adverse events.', 'eventGroups': [{'id': 'EG000', 'title': 'Evening Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nEvening Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.", 'otherNumAtRisk': 18, 'deathsNumAtRisk': 18, 'otherNumAffected': 0, 'seriousNumAtRisk': 18, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Morning Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nMorning Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.", 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 0, 'seriousNumAtRisk': 8, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Thioguanine Levels in Blood (Morning Versus Evening Dosing)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nEvening Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm."}, {'id': 'OG001', 'title': 'Morning Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nMorning Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am."}], 'classes': [{'categories': [{'measurements': [{'value': '175.04', 'spread': '106.89', 'groupId': 'OG000'}, {'value': '225.65', 'spread': '155.05', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks post baseline visit.', 'description': 'This is to examine if the intervention results in a greater level of thioguanine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.', 'unitOfMeasure': 'pmol/8 x 10^8 RBC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'During the analysis, the PI and study team grouped participants by their AM and PM medication administration, regardless of what condition or medication they were on. UC and CD are types of IBD, so the analysis focuses on timing of medication in IBD. Unable to find and recruit UC patients on 6-MP.'}, {'type': 'PRIMARY', 'title': 'Harvey Bradshaw Activity Index', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nEvening Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm."}, {'id': 'OG001', 'title': 'Morning Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Ulcerative Colitis taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nMorning Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am."}], 'classes': [{'categories': [{'measurements': [{'value': '2.15', 'spread': '1.71', 'groupId': 'OG000'}, {'value': '3.09', 'spread': '2.71', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks post baseline visit.', 'description': 'Harvey Bradshaw Activity Index has 5 questions. The final score is totaled and will fall into the following categories, which are used to define the severity of the disease: \\>16 severe diseases, 8-16 moderate disease, 5-7 mild disease, \\<5 remission. Scores range from 0 ( lowest possible score) to 17.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'During the analysis, the PI and study team grouped participants by their AM and PM medication administration, regardless of what condition or medication they were on. UC and CD are types of IBD, so the analysis focuses on timing of medication in IBD. Unable to find and recruit UC patients on 6-MP.'}, {'type': 'PRIMARY', 'title': 'Short Inflammatory Bowel Disease Questionnaire', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nEvening Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm."}, {'id': 'OG001', 'title': 'Morning Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nMorning Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am."}], 'classes': [{'categories': [{'measurements': [{'value': '5.83', 'spread': '0.56', 'groupId': 'OG000'}, {'value': '5.91', 'spread': '0.63', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks post baseline visit.', 'description': 'Quality of Life Measure Score:1-7 (The higher the number the greater the quality of life)', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'During the analysis participants were grouped by AM and PM administration. UC and CD are types of IBD. The study team was unable to recruit Ulcerative Colitis individuals on 6-MP as was originally intended.'}, {'type': 'PRIMARY', 'title': '6-Methylmercaptopurine Levels in Blood', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nEvening Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm."}, {'id': 'OG001', 'title': 'Morning Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nMorning Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am."}], 'classes': [{'categories': [{'measurements': [{'value': '2395.27', 'spread': '2880.26', 'groupId': 'OG000'}, {'value': '825.15', 'spread': '1023.34', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks post baseline visit.', 'description': 'This is to examine if the intervention results in a lower level of 6-Methylmercaptopurine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.', 'unitOfMeasure': 'pmol/8 x 10 ^8 RBC', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'During the analysis, the PI and study team grouped participants by their AM and PM medication administration, regardless of what condition or medication they were on. UC and CD are types of IBD, so the analysis focuses on timing of medication in IBD. Unable to find and recruit UC patients on 6-MP.'}, {'type': 'SECONDARY', 'title': 'Munich Chronotype Questionnaire ( MCTQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Evening Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nEvening Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm."}, {'id': 'OG001', 'title': 'Morning Group Medication Administraion', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercatopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nMorning Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am."}], 'classes': [{'categories': [{'measurements': [{'value': '3.70', 'spread': '1.09', 'groupId': 'OG000'}, {'value': '2.57', 'spread': '1.21', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '10 weeks post baseline visit.', 'description': "This questionnaire is used to collect primary sleep times, such as bed- and rise-times, including the time a person is fully awake, sleep latency and inertia, in addition to other time points. The MCTQ uses the midpoint of sleep between sleep onset and offset to assess chronotype. Chronotype is your body's natural time to be awake or asleep at certain times. Total scores can range from 16 to 86, with the lowest values representing extreme-late chronotype. For this study corrected midpoint of sleep (MSFc) was calculated. This information is combined to determine the mean time of day at which respondents were more likely to feel most alert. The numbers provided in the outcome measure data table represent time (hour and minute). The hour has been converted to military time and the minutes were converted to decimals.", 'unitOfMeasure': 'hours', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'During the analysis, the PI and study team grouped participants by their AM and PM medication administration, regardless of what condition or medication they were on. UC and CD are types of IBD, so the analysis focuses on timing of medication in IBD. Unable to find and recruit UC patients on 6-MP.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Evening Group Medication Administration', 'description': "Participants with Ulcerative Colitis or Crohn's Disease taking Azathioprine or 6- Mercaptopurine orally once a day in the morning were assigned to the evening group. Dosage amount is per clinical care and not defined by the study protocol.\n\nEvening Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm for the duration of the study (10 weeks)."}, {'id': 'FG001', 'title': 'Morning Group Administration', 'description': "Participants with Ulcerative Colitis or Crohn's Disease taking Azathioprine or 6- Mercaptopurine orally once a day in the evening were assigned to the morning intervention group. Dosage amount is per clinical care and not defined by the study protocol.\n\nMorning Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am for the duration of the study (10 weeks)"}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '9'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '18'}, {'groupId': 'FG001', 'numSubjects': '8'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'Participants were assigned to groups based only on morning vs. evening medication administration status, not on their IBD condition or medication. This study focuses on the timing of medication. It was pre-specified in the protocol to report data based on timing. No plans were made to further stratify the data into more groups. After completing the first research visit, all subjects were asked to take their medication at the opposite time of day from their baseline for 10 weeks.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Evening Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nEvening Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm."}, {'id': 'BG001', 'title': 'Morning Group Medication Administration', 'description': "Participants with Ulcerative Colitis taking 6-Mercatopurine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nParticipants with Crohn's Disease taking Azathioprine or 6-Mercaptopurine orally once a day. Dosage amount is per clinical care and not defined by the study protocol.\n\nMorning Group: Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am."}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '64', 'groupId': 'BG000', 'lowerLimit': '24', 'upperLimit': '85'}, {'value': '32.5', 'groupId': 'BG001', 'lowerLimit': '3', 'upperLimit': '79'}, {'value': '57', 'groupId': 'BG002', 'lowerLimit': '3', 'upperLimit': '85'}]}]}], 'paramType': 'MEDIAN', 'unitOfMeasure': 'years', 'dispersionType': 'FULL_RANGE'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '12', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Caucasian', 'categories': [{'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '21', 'groupId': 'BG002'}]}]}, {'title': 'African American', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2018-06-18', 'size': 352877, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_001.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-01-20T15:48', 'hasProtocol': True}, {'date': '2019-03-10', 'size': 125202, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_000.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2019-08-05T17:08', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be randomized to one of two groups: Evening Time or Morning Time. Participants are used as their own control. The evening time group will take their medication in the evening and the morning time group will take the medication in the morning.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 28}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-04-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-06', 'completionDateStruct': {'date': '2023-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-06-01', 'studyFirstSubmitDate': '2019-08-06', 'resultsFirstSubmitDate': '2023-01-20', 'studyFirstSubmitQcDate': '2020-03-09', 'lastUpdatePostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-06-01', 'studyFirstPostDateStruct': {'date': '2020-03-12', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Thioguanine Levels in Blood (Morning Versus Evening Dosing)', 'timeFrame': '10 weeks post baseline visit.', 'description': 'This is to examine if the intervention results in a greater level of thioguanine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.'}, {'measure': 'Harvey Bradshaw Activity Index', 'timeFrame': '10 weeks post baseline visit.', 'description': 'Harvey Bradshaw Activity Index has 5 questions. The final score is totaled and will fall into the following categories, which are used to define the severity of the disease: \\>16 severe diseases, 8-16 moderate disease, 5-7 mild disease, \\<5 remission. Scores range from 0 ( lowest possible score) to 17.'}, {'measure': 'Short Inflammatory Bowel Disease Questionnaire', 'timeFrame': '10 weeks post baseline visit.', 'description': 'Quality of Life Measure Score:1-7 (The higher the number the greater the quality of life)'}, {'measure': '6-Methylmercaptopurine Levels in Blood', 'timeFrame': '10 weeks post baseline visit.', 'description': 'This is to examine if the intervention results in a lower level of 6-Methylmercaptopurine in the participants. If so, the participants are expected to have less symptom severity. Comparing baseline taken at visit one to visit two levels 10 weeks after intervention start.'}], 'secondaryOutcomes': [{'measure': 'Munich Chronotype Questionnaire ( MCTQ)', 'timeFrame': '10 weeks post baseline visit.', 'description': "This questionnaire is used to collect primary sleep times, such as bed- and rise-times, including the time a person is fully awake, sleep latency and inertia, in addition to other time points. The MCTQ uses the midpoint of sleep between sleep onset and offset to assess chronotype. Chronotype is your body's natural time to be awake or asleep at certain times. Total scores can range from 16 to 86, with the lowest values representing extreme-late chronotype. For this study corrected midpoint of sleep (MSFc) was calculated. This information is combined to determine the mean time of day at which respondents were more likely to feel most alert. The numbers provided in the outcome measure data table represent time (hour and minute). The hour has been converted to military time and the minutes were converted to decimals."}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '16266194', 'type': 'BACKGROUND', 'citation': 'Ardizzone S, Bianchi Porro G. Biologic therapy for inflammatory bowel disease. Drugs. 2005;65(16):2253-86. doi: 10.2165/00003495-200565160-00002.'}, {'pmid': '11218242', 'type': 'BACKGROUND', 'citation': 'Belaiche J, Desager JP, Horsmans Y, Louis E. Therapeutic drug monitoring of azathioprine and 6-mercaptopurine metabolites in Crohn disease. Scand J Gastroenterol. 2001 Jan;36(1):71-6. doi: 10.1080/00365520150218084.'}, {'pmid': '22072847', 'type': 'BACKGROUND', 'citation': 'Bradford K, Shih DQ. Optimizing 6-mercaptopurine and azathioprine therapy in the management of inflammatory bowel disease. World J Gastroenterol. 2011 Oct 7;17(37):4166-73. doi: 10.3748/wjg.v17.i37.4166.'}, {'pmid': '26596920', 'type': 'BACKGROUND', 'citation': 'Grevenitis P, Thomas A, Lodhia N. Medical Therapy for Inflammatory Bowel Disease. Surg Clin North Am. 2015 Dec;95(6):1159-82, vi. doi: 10.1016/j.suc.2015.08.004. Epub 2015 Oct 23.'}, {'pmid': '26525013', 'type': 'BACKGROUND', 'citation': 'Gomez-Gomez GJ, Masedo A, Yela C, Martinez-Montiel Mdel P, Casis B. Current stage in inflammatory bowel disease: What is next? World J Gastroenterol. 2015 Oct 28;21(40):11282-303. doi: 10.3748/wjg.v21.i40.11282.'}, {'pmid': '23259651', 'type': 'BACKGROUND', 'citation': 'Haus E, Sackett-Lundeen L, Smolensky MH. Rheumatoid arthritis: circadian rhythms in disease activity, signs and symptoms, and rationale for chronotherapy with corticosteroids and other medications. Bull NYU Hosp Jt Dis. 2012;70 Suppl 1:3-10.'}, {'pmid': '17978158', 'type': 'BACKGROUND', 'citation': 'Perri D, Cole DE, Friedman O, Piliotis E, Mintz S, Adhikari NK. Azathioprine and diffuse alveolar haemorrhage: the pharmacogenetics of thiopurine methyltransferase. Eur Respir J. 2007 Nov;30(5):1014-7. doi: 10.1183/09031936.00026107.'}, {'pmid': '40013523', 'type': 'DERIVED', 'citation': 'Hasskamp J, Meinhardt C, Patton PH, Timmer A. Azathioprine and 6-mercaptopurine for maintenance of remission in ulcerative colitis. Cochrane Database Syst Rev. 2025 Feb 27;2(2):CD000478. doi: 10.1002/14651858.CD000478.pub5.'}, {'pmid': '36730289', 'type': 'DERIVED', 'citation': 'Swanson GR, Biglin M, Raff H, Chouhan V, Jochum S, Shaikh M, Francey L, Bishehsari F, Hogenesch J, Keshavarzian A. Impact of Chronotherapy on 6-Mercaptopurine Metabolites in Inflammatory Bowel Disease: A Pilot Crossover Trial. Clin Transl Gastroenterol. 2023 Feb 1;14(2):e00549. doi: 10.14309/ctg.0000000000000549.'}], 'seeAlsoLinks': [{'url': 'https://www.crohnscolitisfoundation.org/what-is-ibd/medication/immunomodulators', 'label': "Immunomodulators. (2009, January 16). Retrieved from Crohn's \\& Colitis Foundation of America"}, {'url': 'http://www.cdc.gov/ibd/index.htm', 'label': 'Inflammatory bowel disease. (2014, September 4). Retrieved February 25, 2016, from Centers for Disease Control and Prevention Website'}, {'url': 'http://www.uptodate.com/contents/6-mercaptopurine-6-mp-metabolite-monitoring-and-tpmt-testing-in-the-treatment-of-inflammatory-bowel-disease-with-6-mp-or-azathioprine', 'label': 'MacDermott, R. P. (2016). 6-mercaptopurine (6-MP) metabolite monitoring and TPMT testingin the treatment of inflammatory bowel disease with 6-MP or azathioprine. RetrievedMarch 6, 2016, from UpToDate website'}]}, 'descriptionModule': {'briefSummary': 'This study aims to determine if there is any difference in the efficacy of Inflammatory Bowel Disease (IBD) medication and disease outcomes when taken in the morning or in the evening. The IBD medications being observed are azathioprine and 6-mercaptopurine. The study team believes that there may be a benefit to taking the medication at a certain time of day. To test this theory the study asks participants who are already taking either azathioprine or 6-mercaptopurine for IBD to take the medication consistently at either the morning or in the evening based on when they currently take their medication. Participation is up to 10 weeks +/- 3 days. There will be 2 study visits where the participant will be asked to fill in questionnaires related to their IBD symptoms, their sleep habits, sleep quality, and general health information followed by a blood draw.', 'detailedDescription': "The objective of this study is to determine whether the timing of drug administration to treat inflammatory bowel disease (IBD) has an effect on patient outcomes. Primary objective: Determine whether there is a difference in outcomes seen when patients are assigned to take their prescribed immunomodulator (IM) - either Azathioprine or 6-Mercaptopurine - at either a morning delivery time or evening delivery time.\n\nThe Investigator hypothesize that administration time of immunomodulators (IMs) during the day can affect the clinical outcomes in IBD patients.\n\nSpecific Aims Include:\n\n* Determine whether morning vs. evening dosing of patients' prescribed IMs (either Azathioprine or 6-Mercaptopurine) could affect the subclinical markers of inflammation related to disease.\n* Determine whether morning vs. evening dosing of patients' prescribed IMs (either Azathioprine or 6-Mercaptopurine) could affect endoscopic outcomes.\n* Determine whether morning vs. evening dosing of IMs affect their biochemical side effects, as is routinely monitored as part of the patients' clinical care.\n* Determine if outcomes correlate with patients' chronotype, as determined by standard questionnaires (the Munich Chronotype Questionnaire).\n\nDescription of Procedures: After signing the informed consent form, subjects will be asked to answer the Inflammatory Bowel Disease Questionnaire (IBDQ), the Munich Chronotype Questionnaire (MCTQ), the Harvey Bradshaw questionnaire, and a demographics survey. All six of these questionnaires are included with this IRB. Next, patients will be assigned a time (morning or evening) to self administer their prescribed medication for 10 weeks. Patients who currently take their medication in the morning will be asked to switch to an evening delivery and patients who currently take their medication at night will be asked to switch to a morning delivery. The group assigned to morning delivery time will be told to take their medication between 6am and 11am. The group assigned to evening delivery time will be told to take their medication between 6pm and 11pm. Lastly, patients will be asked to give a blood sample to test for complete blood count (CBC), comprehensive metabolic panel (CMP), C-reactive protein (CRP), methylmercaptopurine (6-MMP), and thioguanine nucleotides (6-TG). Plasma and serum isolated from the blood sample will be temporarily stored to measure inflammatory cytokines after every 20 subjects complete the study.\n\nWithin a 6-10 week window, as part of their clinical care, subjects will come in to assess their clinical status while undergoing biochemical monitoring every 2-4 weeks. Data from their endoscopic examination, if done, will also be collected.\n\nAfter 10 weeks, the subjects will be asked to complete the IBDQ and Harvey Bradshaw questionnaire. In addition, a blood sample will be obtained to measure the same metabolite levels and other biochemical indications of disease as stated above. Again, plasma and serum will be isolated from the blood sample and stored."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Above the ages of 18\n* Diagnosis of Crohn's Disease or Ulcerative Colitis\n* Currently taking azathioprine or 6-mercaptopurine\n* Willing to sign study consent form\n\nExclusion Criteria:\n\n* Vulnerable population (pregnant, prisoner, non-English speaking or cognitively impaired)\n* Breastfeeding subject\n* Have a history of complications related to immunomodulatory therapy\n* Participating in other research studies involving research interventions\n* Treated with dual corticosteroid and immunomodulatory therapy"}, 'identificationModule': {'nctId': 'NCT04304950', 'briefTitle': 'Chronotherapy in Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Rush University Medical Center'}, 'officialTitle': 'Chronotherapy in Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': '16040505'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Morning', 'description': "Participants with Ulcerative Colitis or Crohn's Disease taking 6-Mercatopurine or Azathioprine orally once a day in the evening were assigned to the morning group. Instead of taking their medication at their usual PM time, they were instructed to take their medications in the morning for the duration of the study-10 weeks. The dosage amount is per clinical care and not defined by the study protocol.", 'interventionNames': ['Drug: Morning Group']}, {'type': 'EXPERIMENTAL', 'label': 'Evening', 'description': "Participants with Ulcerative Colitis or Crohn's Disease taking 6-Mercatopurine or Azathioprine orally once a day in the morning were assigned to the evening group. Instead of taking their medication at their usual AM time, they were instructed to take their medications in the evening for the duration of the study-10 weeks. The dosage amount is per clinical care and not defined by the study protocol.", 'interventionNames': ['Drug: Evening Group']}], 'interventions': [{'name': 'Evening Group', 'type': 'DRUG', 'description': 'Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 pm and 11:00 pm.', 'armGroupLabels': ['Evening']}, {'name': 'Morning Group', 'type': 'DRUG', 'description': 'Participants will take their IBD medication (either azathioprine or 6-mercaptopurine) between 6:00 am and 11:00 am.', 'armGroupLabels': ['Morning']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Rush University Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Garth Swanson, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rush University Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rush University Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': "Associate Professor of Medicine Director, Rush Center of Crohn's & Colitis Director, Clinical Chronobiology Center", 'investigatorFullName': 'Garth Swanson, MD', 'investigatorAffiliation': 'Rush University Medical Center'}}}}