Burden of Nintedanib Non-adherence Among Idiopathic Pulmonary Fibrosis (IPF) Patients
Completed
Conditions studied: Idiopathic Pulmonary Fibrosis
In brief
This study has two objectives: 1. To assess the association between nintedanib adherence trajectory group (as measured from a Group-based Trajectory Modelling (GBTM)) and health care resource use, with a focus on inpatient hospitalization, among patients with Idiopathic Pulmonary Fibrosis (IPF). 2. To assess the association between a patient's nintedanib adherence trajectory group (as measured from a GBTM) and their medical costs among patients with IPF.
Key facts
- Study ID
- NCT05870956
- Run by
- Boehringer Ingelheim
- People needed
- 1798
- Starts
- 2023-05-16
- Expected to finish
- 2023-06-30
- Last updated by the study team
- 2024-10-01
Who can join
Age: 66 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Newly initiated nintedanib during 10/01/2014 to 12/31/2018
- Were at least 66 years old as of the date of their first nintedanib prescription claim (index date)
- Qualified for Medicare based on age
- Had at least 12 months of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months after the index date (follow-up period)
- Had at least one inpatient or two outpatient claims (>14 days apart) with a diagnosis code for IPF (ICD-10-CM: J84.112; ICD-9-CM: 516.31) during the baseline period
You may not qualify if…
- Had any history of pirfenidone or nintedanib use during the baseline period
- Had any history of lung transplant during the baseline, index date or follow-up periods
- Had any claims for skilled nursing facility, long-term care facility or hospice during the baseline, index date or follow-up period
- Had evidence (≥2 ICD-9-CM or ICD-10-CM diagnosis codes on different dates) during the baseline period of any of the following conditions: lung cancer, autoimmune, or connective tissue diseases (i.e., rheumatoid arthritis (RA), sarcoidosis, systemic lupus erythematosus (SLE), dermatopolymyositis, systemic sclerosis, Sjogren's, and mixed connective tissue disease (CTD)) during the baseline period
- Had dual eligibility of Medicare and Medicaid
- Had history of using pirfenidone at the same time with nintedanib during follow-up
Where it is running
- Medicus Economics, LCC — Milton, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.