Clinical trial
Real-World Medication Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis Patients
Name
1199-0471
Description
This is a non-interventional cohort study using existing administrative data from the U.S. Medicare program.
This study has two objectives:
* Identification of adherence trajectories of nintedanib among Idiopathic Pulmonary Fibrosis (IPF) patients.
* Understanding characteristics of patients within each nintedanib adherence trajectory among IPF patients.
Trial arms
Trial start
2021-08-23
Estimated PCD
2021-12-30
Trial end
2021-12-30
Status
Completed
Treatment
Nintedanib
Nintedanib
Arms:
Idiopathic Pulmonary Fibrosis Patients
Size
1798
Primary endpoint
Adherence Trajectories to Nintedanib Among Idiopathic Pulmonary Fibrosis (IPF) Patients
Up to 1 year
Eligibility criteria
Inclusion criteria:
* 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 (365 days) of continuous enrollment in Medicare Parts A, B and D before (baseline period) and 12 months (360 days) after the index date (follow-up period)
* Had at least one inpatient or two outpatient claims (\>14 days apart) with a diagnosis code for Idiopathic Pulmonary Fibrosis (IPF) during the baseline period
Exclusion criteria:
* 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 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
Protocol
{'studyType': 'OBSERVATIONAL', 'patientRegistry': False, 'designInfo': {'observationalModel': 'COHORT', 'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'count': 1798, 'type': 'ACTUAL'}}
Updated at
2024-04-19
1 organization
1 product
1 indication
Organization
Boehringer IngelheimProduct
NintedanibIndication
Idiopathic Pulmonary Fibrosis