The Steritas Pediatric Glucocorticoid Toxicity Index (pGTI) is being applied in the Steroid Treatment Trial in JIA (STAR-JIA), a clinical trial comparing the efficacy, safety, and cost-effectiveness of intravenous versus oral glucocorticoids for children and young people with Juvenile Idiopathic Arthritis (JIA). Alder Hey Children’s NHS Foundation Trust and the Liverpool Clinical Trials Centre are conducting the trial, which is funded by the National Institute for Health and Care Research.
STAR-JIA Trial Details
The STAR-JIA trial is a randomized controlled study designed to evaluate the optimal route of steroid administration for treating inflammation in JIA. A key component of the trial is the implementation of the pGTI to compare the toxicity profiles of intravenous versus oral steroids. Juvenile idiopathic arthritis is the most common rheumatic disease in children, and glucocorticoids (oral and intravenous) and methotrexate are standard treatments, despite limited evidence on optimal dosing, comparative effectiveness, safety, and cost-effectiveness.
Steritas pGTI
The Steritas pGTI offers a structured method for assessing steroid toxicity in children aged 2 to 18 years. It measures and monitors steroid toxicity in young patients, providing weighted scores that enable researchers, clinicians, and regulators to evaluate the impact of steroid-sparing treatments. The pGTI is designed to be fast, accurate, and easy to implement. Its use in the STAR-JIA trial will allow researchers to assess the outcomes of intravenous and oral glucocorticoid protocols in children.
Expert Commentary
Associate Professor Clare Pain, who leads the trial across the UK, emphasized the potential of the initiative: "By integrating advanced clinical outcome assessments like the pGTI into clinical trials, we are not just advancing research but also directly enhancing clinical practice and patient health."
The pGTI was developed at Massachusetts General Hospital with an international group of pediatric subspecialists. Steritas is the sole licensing entity worldwide for the pGTI, which is part of Steritas’ STOX® Suite of clinical outcome assessments of steroid toxicity.
Industry Perspective
Martha Stone, CEO of Steritas, stated, "The STAR-JIA trial is embarking on a vital new approach to measuring steroid-toxicity in the clinic as part of a randomized clinical trial... Its first use in clinical practice is an opportunity to catch emerging toxicity before it does lasting harm to patients."
