All-Case Surveillance of Ofev in Patients With IPF in Japan

Boehringer Ingelheim

Status: Completed

Conditions: Idiopathic Pulmonary Fibrosis

Treatments: Drug: Nintedanib

Study type: Observational

Funder types: Industry

Identifiers

NCT02607722

1199.202

Details and patient eligibility

About

This is a non-interventional study based on new data collection to gather real-world information (i.e., data under routine medical practice) on safety and effectiveness of the Ofev® Capsules treatment.

The study will consist of a baseline visit and follow-up visits at Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 for patients who have newly initiated Ofev® Capsules. The patients will be followed up until discontinuation of Ofev® Capsules treatment.

As this is an observational study, no specific treatment is mandated or withheld from the patients. The choice of maintenance treatment for IPF must be according to regular medical practice and at the discretion of the physician (i.e., no randomised assignment of patient to treatment is performed).

All patients administrated Ofev® Capsules after the launch at the sites contracted with the sponsor will be registered. The Case Report Forms (CRFs) of 1000 patients will be collected. However the patient registration continues until the approval condition has been removed.

Patients participating in the subsequent follow-up will undergo regular observations. These observations should be reported after approximately Week 4, 13, 26, 39, 52, 65, 78, 91 and 104 since the initiation of Ofev® Capsules as long as they continue to receive the treatment. Patients will not be followed any longer once they are reported to have discontinued the Ofev® Capsules treatment.

Enrollment: 10,117 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion criteria:

Essentially, patients are diagnosed with IPF based upon the most recent the American Thoracic Society (ATS), the European Respiratory Society (ERS), the Japanese Respiratory Society (JRS), and the Latin American Thoracic Association (ALAT) guideline.

Trial design

10,117 participants in 1 patient group

IPF patients receiving Nintedanib

Description:

Patients diagnosed with idiopathic pulmonary fibrosis (IPF) based upon the most recent ATS/ERS/JRS/ALAT guideline and who initiated treatment with Ofev Capsules after the launch were registered into this study basically within 14 days from initiation of Ofev Capsules (from October 2015 to May 2023).

Treatment:

Drug: Nintedanib