NCT06485635

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10,646

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Oct 2024

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 10, 2024

Completed
23 days until next milestone

First Posted

Study publicly available on registry

July 3, 2024

Completed
4 months until next milestone

Study Start

First participant enrolled

October 16, 2024

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 7, 2026

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 7, 2026

Completed
Last Updated

April 15, 2026

Status Verified

April 1, 2026

Enrollment Period

1.5 years

First QC Date

June 10, 2024

Last Update Submit

April 14, 2026

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • 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

    up to 2 years

  • Number of patients adherent to AF treatment

    up to 30 months

  • Percentage of the target cumulative dose of treatment received by the patients

    up to 30 months

  • +5 more secondary outcomes

Study Arms (1)

Patients with a reimbursement of AF treatment

Drug: NintedanibDrug: Pirfenidone

Interventions

Nintedanib

Patients with a reimbursement of AF treatment

Pirfenidone

Patients with a reimbursement of AF treatment

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinityx

Boulogne-Billancourt, 92100, France

Location

Related Links

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

nintedanibpirfenidone

Condition Hierarchy (Ancestors)

Pulmonary FibrosisLung Diseases, InterstitialLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 10, 2024

First Posted

July 3, 2024

Study Start

October 16, 2024

Primary Completion

April 7, 2026

Study Completion

April 7, 2026

Last Updated

April 15, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

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

Locations