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

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: Nintedanib

• Registration Number: NCT02607722
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-31
• Study First Submitted: 2015-09-02
• Study First Submitted QC: 2015-11-16
• Study First Posted: 2015-11-18
• Primary Completion: 2023-05-02
• Study Completion: 2023-05-02
• Results First Submitted: 2024-04-25
• Status Verified: 2024-10
• Results First Submitted QC: 2024-10-08
• Last Update Submitted: 2024-10-08
• Results First Posted: 2024-10-11
• Last Update Posted: 2024-10-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10117

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
IPF patients receiving Nintedanib	Nintedanib	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).

Primary Outcome Measures

Name	Time	Method
Number of Patients With Any Suspected Adverse Drug Reactions (ADRs)	Up to 104 weeks	Number of patients with any suspected Adverse Drug Reactions (ADRs) is presented.

Secondary Outcome Measures

Name	Time	Method
Absolute Change From Baseline in Forced Vital Capacity (FVC) at Week 104	At baseline and at week 104	Absolute change from baseline in Forced Vital Capacity (FVC) at Week 104 is presented.; Forced vital capacity (FVC) is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured in Milliliter by spirometry.