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This study will help to better understand the persistence rate to antifibrotic (AF) treatment in real life in France and to identify potential areas for improvement by investigating the factors associated with a non-persistence rate to AF treatment.
Primary objective of the study is to measure the percentage of patients still treated up to 30 months after AF treatment initiation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with a reimbursement of AF treatment |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nintedanib | Drug | Nintedanib |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Persistence to antifibrotic (AF) treatment (measured as percentage of patients still treated up to 30 months after AF treatment initiation) | up to 30 months |
| Measure | Description | Time Frame |
|---|---|---|
| AF prevalence in French population | up to 5 years | |
| AF incidence in French population | up to 4 years | |
| Number of AF treated patients split by indication |
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Inclusion criteria:
All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.
Exclusion criteria:
No exclusion criteria will be applied.
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All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Clinityx | Boulogne-Billancourt | 92100 | France |
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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.clinicalstudies.boehringer-ingelheim.com/msw/datasharing
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| ID | Term |
|---|---|
| D054990 | Idiopathic Pulmonary Fibrosis |
| ID | Term |
|---|---|
| D011658 | Pulmonary Fibrosis |
| D017563 | Lung Diseases, Interstitial |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C530716 | nintedanib |
| C093844 | pirfenidone |
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| Pirfenidone |
| Drug |
Pirfenidone |
|
Indications:
|
| up to 2 years |
| Number of patients adherent to AF treatment | In incident AF patients, percentage of days covered (PDC) will be calculated at different time point to measure the adherence to AF treatment for patients persistent to treatment at this time point. The PDC is the ratio dividing the number of days exposed by the number of days in the period evaluated. A PDC≥ 80% is considered as a good adherence to medication. | up to 30 months |
| Percentage of the target cumulative dose of treatment received by the patients | up to 30 months |
| Influence of factors (yes/no) associated with persistence to AF treatments | For a pre-determined list of variables (as defined in the study protocol) in incident AF patients, a multivariate time-dependant Cox model will test several covariates to check if they are associated with persistence to AF treatment. | up to 30 months |
| Number of patients with switch from one AF treatment to the another with no treatment stop | up to 5 years |
| Number of patients at site of follow-up (identified as 2 lung function tests performed in the center) | up to 5 years |
| Overall Survival (defined as time from index date (first reimbursement of AF treatment) to death from any cause) | up to5 years |
| Event-free survival | Defined as the time from index date to
| up to 5 years |