Clinical trial NCT03047031: Post Marketing Surveillance of Nintedanib in Indian Patients With Idiopathic Pulmonary Fibrosis
Official title: An Active Surveillance to Monitor the Real World Safety in Indian Patients Prescribed Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Idiopathic Pulmonary Fibrosis
Lead sponsor: Boehringer Ingelheim
Sponsor class: INDUSTRY
First posted: 2017-02-08
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
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.

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Incidence Rate of All ADRs in Nintedanib Treated Patients
timeFrame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
measure: Incidence Rate of All SAEs in Nintedanib Treated Patients
timeFrame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
Secondary outcomes:
measure: Percentage of Patients With AEs Leading to Permanent Dose Reductions of Study Drug
timeFrame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
measure: Percentage of Patients With AEs Causing Dose Interruption of Study Drug
timeFrame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
measure: Percentage of Patients With AEs Leading to Permanently Discontinuation of Study Drug
timeFrame: From the day Nintedanib was initiated until 52 weeks, up to 52 weeks.
Other outcomes:
Locations:
city: Jaipur
country: India
facility: Asthma Bhawan
city: Kolkata
country: India
facility: CK Birla Hospitals, The Calcutta Medical Research Institute
city: Kolkatta
country: India
facility: National Allergy Asthma Bronchitis Institute, Kolkata
city: Lucknow
country: India
facility: King George Medical University
city: Lucknow
country: India
facility: Midland Healthcare and Research Centre
city: Mumbai
country: India
facility: Bhatia Hospital
city: Mumbai
country: India
facility: P.D. Hinduja National Hospital
city: Pune
country: India
facility: Grant Medical Foundation, Ruby Hall Clinic
Study officials:
References: