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Validation of an Auto-Injector for Juvenile Idiopathic Arthritis


Title Late Formative/Usability Validation of an Auto-Injector for Juvenile Idiopathic Arthritis
Therapeutic Area Juvenile Idiopathic Arthritis (Floating)
Principal Investigator Diana Milojevic, MD
Min Age 12 Years
Max Age 17 Years
Gender All
Contact Bipin Malla
617 636-4825

Overview

The goal of this study is to see how easy or hard it is for children with Juvenile Idiopathic Arthritis to learn how to use the auto-injector. The auto-injector is being made to deliver medication to people with inflammation or swelling of the joints (JIA).

Study Details

Inclusion Criteria

  • Children with diagnosis of Juvenile Idiopathic Arthritis
  • Weight > to 66 lbs (30kgs)

Exclusion Criteria

  • Age less than 12 years or greater than 17 years
  • Participated in an auto-injector study in the last 3 months

Study Requirements

There will be a total of 2 visits for the study which will occur 14 days apart. Each visit will last approximately 1 hour and will take place in the Pediatric Rheumatology office. During both of these visits subjects will perform/simulate an injection into a foam/rubber pad. The auto-injector will be filled with sterile water and subjects will not be using the device into themselves. There are no blood draws or any other form of medical tests.