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

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

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.

Study Overview

• Status: Completed
• Conditions: Idiopathic Pulmonary Fibrosis

• Study Type: Observational
• Enrollment (Actual): 21

Contacts and Locations

Study Locations

• India
  • Chennai, India, 600100
    • Gleneagles Global Hospital
  • Coimbatore, India, 641044
    • Sri Ramakrishna Hospital
  • Jaipur, India, 302039
    • Asthma Bhawan
  • Kolkata, India, 700027
    • CK Birla Hospitals, The Calcutta Medical Research Institute
  • Kolkatta, India, 700017
    • National Allergy Asthma Bronchitis Institute, Kolkata
  • Lucknow, India, 226003
    • King George Medical University
  • Lucknow, India, 226006
    • Midland Healthcare and Research Centre
  • Mumbai, India, 400007
    • Bhatia Hospital
  • Mumbai, India, 400016
    • P.D. Hinduja National Hospital
  • Pune, India, 411001
    • Grant Medical Foundation, Ruby Hall Clinic

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

This active surveillance will include all IPF patients treated with nintedanib per the inclusion/exclusion criteria at selected centres during the first two years after the commercial availability of the drug.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Other

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort
Group A; 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; 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; Patients who have been newly prescribed nintedanib at the time of participation in the active surveillance

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Boehringer Ingelheim

Publications and helpful links

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2017
• Primary Completion (Actual): July 21, 2022
• Study Completion (Actual): July 21, 2022

Study Registration Dates

• First Submitted: February 7, 2017
• First Submitted That Met QC Criteria: February 7, 2017
• First Posted (Estimate): February 8, 2017

Study Record Updates

• Last Update Posted (Actual): August 23, 2022
• Last Update Submitted That Met QC Criteria: August 22, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: 1199-0280

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

IPD Plan Description

After the study is completed and the primary manuscript is accepted for publishing, researchers can use this following link https://www.mystudywindow.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Also, Researchers can use the following link https://www.mystudywindow.com/msw/datasharing to find information in order to request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

The data shared are the raw clinical study data sets.

• IPD Sharing Time Frame: After all regulatory activities are completed in the US and EU for the product and indication, and after the primary manuscript has been accepted for publication.
• IPD Sharing Access Criteria: For study documents - upon signing of a 'Document Sharing Agreement'. For study data - 1. after the submission and approval of the research proposal (checks will be performed by both the independent review panel and the sponsor, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a 'Data Sharing Agreement'.
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP); Clinical Study Report (CSR)

Drug and device information, study documents

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