Steritas LLC, a company dedicated to improving patient care for steroid-treated patients, has announced that Alder Hey Children’s NHS Foundation Trust, and Liverpool Clinical Trials Centre, will apply its Steritas Paediatric Glucocorticoid Toxicity Index (PGTI) in a clinical trial to compare the efficacy, safety and cost-effectiveness of intravenous versus oral glucocorticoids (steroids) for children and young people with juvenile idiopathic arthritis (JIA).
The randomized controlled trial, called the STAR-JIA trial (STeroid TeaagainAComment TRin ial lived), aims not only to understand which route of steroid administration is most effective for treating inflammation in JIA, but will also implement PGTI to compare the toxicity of intravenous versus oral steroids, marking a significant advance in paediatric rheumatology. The study is funded by the National Institute for Health and Care Research.
Juvenile idiopathic arthritis is the most common rheumatic disease in children. Glucocorticoids (oral and intravenous) and methotrexate are the standard of care, even though there is limited evidence about the optimal dose, comparative effectiveness, safety, and cost-effectiveness of intravenous versus oral glucocorticoids.
The Steritas PGTI provides a systematic approach to assessing steroid-toxicity in children aged 2 to 18 years. It is used to measure and monitor steroid-toxicity in young patients. This tool provides weighted scores of steroid-toxicity that enable researchers, clinicians and regulators to evaluate the effect of steroid-sparing therapies. The PGTI is fast, accurate and easy to implement. The use of the Steritas PGTI in this research initiative will allow researchers to assess the outcomes of intravenous and oral glucocorticoid protocols in children.
Associate Professor Claire Penn, who is leading the trial in the UK, highlights the potential of this initiative: “By integrating advanced clinical outcome assessments like the PGTI into clinical trials, we are not only advancing research but also directly enhancing clinical practice and patient health.”
PGTI was developed at Massachusetts General Hospital in collaboration with an international group of pediatric subspecialists. Steritas is the exclusive licensing entity worldwide for PGTI, which is part of Steritas' STOXX. Clinical Outcome Assessment Group of Steroid Toxicity.
The STAR-JIA trial is introducing an important new approach to measuring steroid-toxicity in the clinic as part of a randomized clinical trial. We are pleased to be part of Dr. Penn's research in the United Kingdom and celebrate this first use of pGTI – a clinical research tool – at the point of care. pGTI is part of our STOX The Clinical Outcome Assessment of Steroid Toxicity suite is being used in 80 countries and 1100 trial sites around the world and in approximately 28 different diseases. Its first use in clinical practice is an opportunity to catch emerging toxicities before they cause permanent harm to patients.”
Martha Stone, CEO, Steritas
Principal Investigators – Associate Professor Claire Penn and Professor Athimalaipet Ramanan.