New Innovative Clinical Trial Launches to Improve Childhood Medication Dosing and Adherence
The Duke Clinical Research Institute (DCRI) just launched an innovative direct-to-family clinical trial to study medication dosing in children and teens with lupus. The virtual study will also leverage digital technology to test if it helps with medication adherence. The study represents a collaboration between DCRI, the Childhood Arthritis and Rheumatology Research Alliance (CARRA) and the Lupus Foundation of America.
Managing clinical research remotely has become critical during the COVID-19 pandemic, and the iPERSONAL (Individual Patient Exposure and Response in Pediatric Lupus) study enables children and their families to easily participate in this groundbreaking research from the comfort of their home. This first-of-its-kind study will collect information on the best dose of hydroxychloroquine (Plaquenil) in children to reduce lupus disease activity. iPERSONAL will also investigate whether electronic pill bottles are effective in reminding children and teens to take their medication.
The study looks to recruit 20 children and teens with lupus from the CARRA Registry, a registry that identifies children and adolescents with rheumatic conditions. Over the course of six months, participants will be visited by a mobile research nurse to monitor symptoms, collect biological samples, and will receive an electronic pill bottle, Fitbit, and smartphone. The iPERSONAL study is funded by the US Food and Drug Administration, and guided and supported by a Stakeholder and Patient Advisory Group of children and teens living with lupus, their caregivers, and representatives from each collaborative organization.
The Lupus Foundation of America is part of the working group that helps advise on this innovative study to understand optimal dosing of hydroxychloroquine for youth with lupus. The Foundation will continue to report on this study and its findings. Learn more about LFA and its support of childhood lupus research.