Ignite Creation Date:
2025-12-24 @ 9:24 PM
Ignite Modification Date:
2025-12-25 @ 7:10 PM
Study NCT ID:
NCT05875532
Status:
COMPLETED
Last Update Posted:
2024-09-19
First Post:
2023-04-30
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Study of Progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Incidence/Management and Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}], 'ancestors': [{'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clintriage.rdg@boehringer-ingelheim.com', 'phone': '1-800-243-0127', 'title': 'Boehringer Ingelheim, Call Center', 'organization': 'Boehringer Ingelheim'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'The Medical Data Vision (MDV) database did not have pulmonary function test results and there was no evidence of using claims data to define the events fibrosing Interstitial Lung Disease (ILD) patients other than Idiopathic Pulmonary Fibrosis (IPF) and progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in the validated algorithm. Data generated in the clinics/hospitals other than hospitals included in the MDV database were not captured.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event information was not applicable for this study.', 'description': 'As this is a non-interventional study with secondary use of data retrieved from Medical Data Vision database, safety monitoring and safety reporting on an individual case level is not applicable. All-Cause Mortality, Serious Adverse Events and Other Adverse Events are not collected in the database. "0" total Number of Participants at Risk means "All-Cause Mortality, Serious, and Other (Not Including Serious) Adverse Events were not monitored/assessed', 'eventGroups': [{'id': 'EG000', 'title': 'Patients With an ILD Other Than IPF', 'description': 'Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.', 'otherNumAtRisk': 0, 'deathsNumAtRisk': 0, 'otherNumAffected': 0, 'seriousNumAtRisk': 0, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34960', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With an ILD Other Than IPF', 'description': 'Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.'}], 'classes': [{'title': '6 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '27770', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.147', 'groupId': 'OG000', 'lowerLimit': '0.143', 'upperLimit': '0.151'}]}]}, {'title': '12 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '20888', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.249', 'groupId': 'OG000', 'lowerLimit': '0.244', 'upperLimit': '0.253'}]}]}, {'title': '18 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '15921', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.334', 'groupId': 'OG000', 'lowerLimit': '0.329', 'upperLimit': '0.34'}]}]}, {'title': '24 months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '12117', 'groupId': 'OG000'}]}], 'categories': [{'measurements': [{'value': '0.395', 'groupId': 'OG000', 'lowerLimit': '0.389', 'upperLimit': '0.401'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020', 'description': "The cumulative incidence probability is the estimate of the risk a patient will experience by 6, 12, 18 and 24 months after the second diagnosis of fibrosing ILD (index date) of progression to PF-ILDs. It is the complement of the Kaplan-Meier estimates. The Greenwood's variance estimate was used to calculate the 95% confidence interval.\n\nDisease progression was defined as 3 or more pulmonary function tests within 365 days, 3 or more tomographies within 365 days, 1 or more claims for oxygen therapy during follow-up, 1 or more respiratory hospitalizations during follow-up, 1 or more claims for palliative care during follow-up, 1 or more lung transplant during follow-up, 1 or more claims for immunosuppressive drugs during follow-up, 1 or more claims for oral corticosteroid during follow-up, and 1 or more claims for Nintedanib during follow-up. Follow-up was between 1-Jan-2013 to 28-May-2020, the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.", 'unitOfMeasure': 'Cumulative incidence probability', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: Patients in Japan with data available in the Medical Data Vision (MDV) database, between 01-Jan-2012 to 28-May-2020, who met all inclusion criteria and none of the exclusion criteria. The number of patients analyzed displays the number of patients at risk of progression at the time of interest.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Treatment of Interest During Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34960', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With an ILD Other Than IPF', 'description': 'Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.'}], 'classes': [{'title': 'Rituximab', 'categories': [{'measurements': [{'value': '49', 'groupId': 'OG000'}]}]}, {'title': 'Tacrolimus', 'categories': [{'measurements': [{'value': '499', 'groupId': 'OG000'}]}]}, {'title': 'Mycophenolate', 'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}]}]}, {'title': 'Cyclosporine', 'categories': [{'measurements': [{'value': '200', 'groupId': 'OG000'}]}]}, {'title': 'Cyclophosphamide', 'categories': [{'measurements': [{'value': '225', 'groupId': 'OG000'}]}]}, {'title': 'Azathioprine', 'categories': [{'measurements': [{'value': '201', 'groupId': 'OG000'}]}]}, {'title': 'Oral corticosteroid', 'categories': [{'measurements': [{'value': '2065', 'groupId': 'OG000'}]}]}, {'title': 'Tocilizumab', 'categories': [{'measurements': [{'value': '46', 'groupId': 'OG000'}]}]}, {'title': 'Nintedanib', 'categories': [{'measurements': [{'value': '472', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7.43 years, from 01-Jan-2013 to 28-May-2020', 'description': 'Number of patients treated with immunosuppressive drugs (Rituximab, Tacrolimus, Mycophenolate, Cyclosporine, Cyclophosphamide, Azathioprine, Tocilizumab), oral corticosteroids, or nintedanib during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: Patients in Japan with data available in the Medical Data Vision (MDV) database, between 01-Jan-2012 to 28-May-2020, who met all inclusion criteria and none of the exclusion criteria.'}, {'type': 'SECONDARY', 'title': 'Number of Patients With Management of Interest During Follow-up Period', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34960', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Patients With an ILD Other Than IPF', 'description': 'Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.'}], 'classes': [{'title': 'Oxygen therapy (HOT)', 'categories': [{'measurements': [{'value': '1641', 'groupId': 'OG000'}]}]}, {'title': 'Lung transplant', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}]}]}, {'title': 'Palliative care (oxygen inhalation, opioid use)', 'categories': [{'measurements': [{'value': '9520', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Up to 7.43 years, from 01-Jan-2013 to 28-May-2020', 'description': 'Number of patients with oxygen therapy (HOT), lung transplant and palliative care (oxygen inhalation, opioid use) as disease management during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Full analysis set: Patients in Japan with data available in the Medical Data Vision (MDV) database, between 01-Jan-2012 to 28-May-2020, who met all inclusion criteria and none of the exclusion criteria.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Patients With an ILD Other Than IPF', 'description': 'Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34960'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34960'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'Retrospective cohort study using the Medical Data Vision (MDV) database to study progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILDs) in a real-world setting in Japan. Data was extracted for the period of 01-Jan-2012 to 28-May-2020 for patients presenting pre-specified ILDs that received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) between 01-Jan-2013 to 6 months before 28-May-2020.', 'preAssignmentDetails': 'Patients that met all inclusion criteria and none of the exclusion criteria were followed from the day after of the second diagnosis of a fibrosing ILD other than IPF - index date - until the end of study period (28-May-2020), the last encounter in the MDV database or in-hospital death, whichever occurs first.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34960', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Patients With an ILD Other Than IPF', 'description': 'Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34960', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '71.13', 'spread': '12.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Age at the second diagnosis of a fibrosing ILD other than IPF - index date', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '34960', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '16597', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '18363', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}], 'populationDescription': 'Full analysis set: Patients in Japan with data available in the Medical Data Vision (MDV) database, between 01-Jan-2012 to 28-May-2020, who met all inclusion criteria and none of the exclusion criteria.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-11-29', 'size': 4574390, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-04-16T04:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34960}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-25', 'studyFirstSubmitDate': '2023-04-30', 'resultsFirstSubmitDate': '2024-04-25', 'studyFirstSubmitQcDate': '2023-05-16', 'lastUpdatePostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-04-25', 'studyFirstPostDateStruct': {'date': '2023-05-25', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-09-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs)', 'timeFrame': 'At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020', 'description': "The cumulative incidence probability is the estimate of the risk a patient will experience by 6, 12, 18 and 24 months after the second diagnosis of fibrosing ILD (index date) of progression to PF-ILDs. It is the complement of the Kaplan-Meier estimates. The Greenwood's variance estimate was used to calculate the 95% confidence interval.\n\nDisease progression was defined as 3 or more pulmonary function tests within 365 days, 3 or more tomographies within 365 days, 1 or more claims for oxygen therapy during follow-up, 1 or more respiratory hospitalizations during follow-up, 1 or more claims for palliative care during follow-up, 1 or more lung transplant during follow-up, 1 or more claims for immunosuppressive drugs during follow-up, 1 or more claims for oral corticosteroid during follow-up, and 1 or more claims for Nintedanib during follow-up. Follow-up was between 1-Jan-2013 to 28-May-2020, the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first."}], 'secondaryOutcomes': [{'measure': 'Number of Patients With Treatment of Interest During Follow-up Period', 'timeFrame': 'Up to 7.43 years, from 01-Jan-2013 to 28-May-2020', 'description': 'Number of patients treated with immunosuppressive drugs (Rituximab, Tacrolimus, Mycophenolate, Cyclosporine, Cyclophosphamide, Azathioprine, Tocilizumab), oral corticosteroids, or nintedanib during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.'}, {'measure': 'Number of Patients With Management of Interest During Follow-up Period', 'timeFrame': 'Up to 7.43 years, from 01-Jan-2013 to 28-May-2020', 'description': 'Number of patients with oxygen therapy (HOT), lung transplant and palliative care (oxygen inhalation, opioid use) as disease management during the follow-up period. The follow-up period was between the second diagnosis of a fibrosing ILD (index date) and end of study (28-May-2020), the last encounter in Medical Data Vision database, or in-hospital death, whichever occurs first.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lung Diseases, Interstitial']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.mystudywindow.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The primary objective for this trial is to investigate the incidence probability of progression to Progressive Fibrosing Interstitial Lung Diseases (PF-ILDs) in patients with fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in real-world setting in Japan.\n\nThe secondary objective is to investigate the characteristics of procedures for management and treatment in patients with fibrosing ILD other than IPF in real-world setting in Japan.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with at least two fibrosing ILD codes (International Statistical Classification of Diseases and Related Health Problems (ICD-10) code or disease code)', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Patients diagnosed with at least two fibrosing Interstitial Lung Disease (ILD) codes on different dates in the patient identification period\n2. Patients aged 18 years and older on the index date\n3. Patients for whom data for the 12 months prior to the index date can be extracted as baseline data\n\nExclusion Criteria:\n\n1. Patients grouped into the underlying disease of Idiopathic Pulmonary Fibrosis (IPF)\n2. Patients who have met PF-ILD progression criteria during the baseline period'}, 'identificationModule': {'nctId': 'NCT05875532', 'briefTitle': 'Study of Progression to Progressive Fibrosing Interstitial Lung Disease (PF-ILD) Incidence/Management and Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Boehringer Ingelheim'}, 'officialTitle': 'Incidence Probability of Progression to Progressive Fibrosing Interstitial Lung Diseases and Status of Management and Treatments in Patients With Fibrosing Interstitial Lung Diseases Other Than Idiopathic Pulmonary Fibrosis in Japan', 'orgStudyIdInfo': {'id': '1199-0523'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with an ILD other than IPF', 'description': 'Patients in Japan with data available in the Medical Data Vision (MDV) database, presenting an underlying pre-specified Interstitial Lung Disease (ILD) between 01-Jan-2012 to 28-May-2020 and received a second diagnosis of a fibrosing ILD other than Idiopathic Pulmonary Fibrosis (IPF) in the period of 01-Jan-2013 to 6 months before 28-May-2020.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '06877', 'city': 'Ridgefield', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Boehringer Ingelheim Pharmaceuticals, Inc.', 'geoPoint': {'lat': 41.28148, 'lon': -73.49818}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization).\n\nFor more details refer to: https://www.mystudywindow.com/msw/datatransparency'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Boehringer Ingelheim', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}