Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis

Study Overview
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Brief Summary
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This is an active surveillance study to monitor the real world safety of nintedanib in Indian patients with Idiopathic Pulmonary Fibrosis. The safety of nintedanib has been assessed in clinical trials.This active surveillance aims to collect the safety data of 200 IPF patients treated with nintedanib in approved indication after the commercial availability of the drug in India (23rd January 2017). The objective is to look at safety of nintedanib in the real world setting.

Official Title
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An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis

Conditions
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Idiopathic Pulmonary Fibrosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with documented diagnosis of Idiopathic Pulmonary Fibrosis (IPF) based upon ATS/ERS/JRS/ALAT 2011 guidelines (nintedanib naïve or pirfenidone pre-treated) who have initiated or will initiate nintedanib according to the package insert after the commercial availability of drug in India (23rd January 2017). Patients in whom it is possible to obtain voluntary informed consent either from the patient or patient's legally authorised representative (applicable for Group B and C patients). Patients in whom data collection is possible from the medical records (applicable for Group A and B patients) Further inclusion criteria apply Exclusion Criteria: Patients who were previously treated with nintedanib. Patients who have initiated or will initiate nintedanib concomitantly with pirfenidone.. Patients who are participating in a clinical trial. Further exclusion criteria apply.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A<br>Patients who started treatment with nintedanib after 23rd January, 2017 and have permanently discontinued the drug (as decided by the investigator) at the time of participation in the active surveillance. | |
| Group B<br>Patients who started treatment with nintedanib after 23rd January, 2017 and are continuing the drug at the time of participation in the active surveillance. | |
| Group C<br>Patients who have been newly prescribed nintedanib at the time of participation in the active surveillance | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all Adverse Drug Reactions (ADRs) in nintedanib treated patients |  | up to 56 weeks | 
| Incidence of all serious adverse events (SAEs) in nintedanib treated patients |  | up to 56 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients who require dose reductions, interruptions and discontinuation due to adverse events |  | up to 56 weeks |