Real-life-persistence to Antifibrotic Treatments (REPEAT)

Real-life-Persistence to Antifibrotic Treatments

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Nintedanib; Drug: Pirfenidone

• Study Type: Observational
• Enrollment (Actual): 10646

Contacts and Locations

Study Locations

• France
  • Boulogne-Billancourt, France, 92100
    • Clinityx

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

All patients with a reimbursement of AF treatment between 2018 and 2022 will be included for analysis.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with a reimbursement of AF treatment	Drug: Nintedanib; Nintedanib; Drug: Pirfenidone; Pirfenidone

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	Indications: Idiopathic Pulmonary Fibrosis (IPF); Interstitial Lung Disease associated with Systemic Sclerosis (SSc-ILD); Progressive Pulmonary Fibrosis (PPF)	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; oxygenotherapy onset; hospitalisation for respiratory exacerbations; hospitalisation for other respiratory diseases; ath from any cause	up to 5 years

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2024
• Primary Completion (Actual): April 7, 2026
• Study Completion (Actual): April 7, 2026

Study Registration Dates

• First Submitted: June 10, 2024
• First Submitted That Met QC Criteria: June 26, 2024
• First Posted (Actual): July 3, 2024

Study Record Updates

• Last Update Posted (Actual): April 15, 2026
• Last Update Submitted That Met QC Criteria: April 14, 2026
• Last Verified: April 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Interstitial; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Antineoplastic Agents; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Inflammatory Agents; Peripheral Nervous System Agents; Enzyme Inhibitors; Antirheumatic Agents; Sensory System Agents; Protein Kinase Inhibitors; Analgesics, Non-Narcotic; Analgesics; Anti-Inflammatory Agents, Non-Steroidal; pirfenidone; nintedanib
• Other Study ID Numbers: 1199-0568

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

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

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No