ReferenceRRK4513

European Adrenal Insufficiency Registry (EU-AIR)

A European Multi-centre Multi-country Post-authorisation Observational Study (registry) of Patients With Chronic Adrenal Insufficiency

Research Summary

This postauthorisationobservational study (registry) of patients with chronic adrenal insufficiency is designed to addto knowledge gained from clinical studies to date by collecting treatment information and characterising the safety oflongtermtreatment with Plenadren compared to other glucocorticoid replacement therapies administered during thecourse of routine clinical practice in Europe with a focus on intercurrent illness adrenal crisis and serious adverseevents (SAEs).Patients suffering from primary or secondary adrenal insufficiency can be enrolled in this study irrespective of their treatment. The decision to prescribe any available and approved glucocorticoid replacement therapy will be entirelythe decision of the clinical care team where the patient is attending visits on a routine basis.For this study patients will visit the participating endocrinology centre according to their routine visit schedule it isexpected that routine visits occur on average once to twice a year although this frequency can vary according to thepatient’s medical need. The protocol does not require the patients to alter their routine visit schedule and treatment.Only those data that are available from routine practice will be collected. No additional assessments are required.Patients will be followed during the course of routine clinical practice for the duration of time that the registry is active.

Research Overview
Sponsor Viropharma
Project Status Open
Proposed End Date 01/07/2017
Study Run through CRF? No
Target number of patients agreed to recruit 200
Recruitment so far 397