Boehringer Ingelheim Pharmaceuticals, Inc.
Ridgefield, Connecticut, 06877, United States
NCT Number: NCT05875532
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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Notify Me18 year and older
All sexes
Observational
Ridgefield, Connecticut, 06877, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: At 6, 12, 18 and 24 months after the index date, defined between 01-Jan-2013 and 6 months before 28-May-2020
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.
Time frame: Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
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.
Time frame: Up to 7.43 years, from 01-Jan-2013 to 28-May-2020
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.
Boehringer Ingelheim
Industry
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
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