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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.
The 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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with an ILD other than IPF | 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs) | 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. Disease 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. | At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020 |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients With Treatment of Interest During Follow-up Period | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed with at least two fibrosing ILD codes (International Statistical Classification of Diseases and Related Health Problems (ICD-10) code or disease code)
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boehringer Ingelheim Pharmaceuticals, Inc. | Ridgefield | Connecticut | 06877 | United States |
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| Label | URL |
|---|---|
| Related Info | View source |
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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).
For more details refer to: https://www.mystudywindow.com/msw/datatransparency
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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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | Patients With an ILD Other Than IPF | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | Patients With an ILD Other Than IPF | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Age at the second diagnosis of a fibrosing ILD other than IPF - index date |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Incidence Probability of Progression to Pulmonary Fibrosing-Interstitial Lung Disease (PF-ILDs) | 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. Disease 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. | 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. | Posted | Number | 95% Confidence Interval | Cumulative incidence probability | At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020 |
Adverse event information was not applicable for this study.
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
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Patients With an ILD Other Than IPF | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Boehringer Ingelheim, Call Center | Boehringer Ingelheim | 1-800-243-0127 | clintriage.rdg@boehringer-ingelheim.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 29, 2023 | Apr 16, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D017563 | Lung Diseases, Interstitial |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| Up to 7.43 years, from 01-Jan-2013 to 28-May-2020 |
| Number of Patients With Management of Interest During Follow-up Period | 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. | Up to 7.43 years, from 01-Jan-2013 to 28-May-2020 |
| Mean |
| Standard Deviation |
| Years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
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| Secondary | Number of Patients With Treatment of Interest During Follow-up Period | 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. | 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. | Posted | Count of Participants | Participants | Up to 7.43 years, from 01-Jan-2013 to 28-May-2020 |
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| Secondary | Number of Patients With Management of Interest During Follow-up Period | 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. | 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. | Posted | Count of Participants | Participants | Up to 7.43 years, from 01-Jan-2013 to 28-May-2020 |
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| Title | Measurements |
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| Cyclosporine |
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| Cyclophosphamide |
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| Azathioprine |
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| Oral corticosteroid |
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| Tocilizumab |
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| Nintedanib |
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| Title | Measurements |
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