Study will allow researchers to assess the outcomes of intravenous and oral glucocorticoid protocols in children
Boston, MA, USA, 24 September 2024: Steritas LLC., a company dedicated to enhancing patient care for steroid-treated patients announced that Alder Hey Children’s NHS Foundation Trust, and the Liverpool Clinical Trials Centre will apply its Steritas Pediatric Glucocorticoid Toxicity Index (pGTI) in a clinical trial to compare 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 STAR-JIA trial (Steroid TreAtment TRial in JIA, aims to understand not only which route of steroid is the most effective for treating inflammation in JIA, but will also implement the pGTI to compare the toxicity of intravenous versus oral steroids, marking a significant advancement in pediatric 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 with limited evidence about optimal dosing, comparative effectiveness, safety and cost-effectiveness of intravenous versus oral glucocorticoids.
The Steritas pGTI provides a systematic approach to assessing steroid-toxicity in children between the ages of 2 and 18 years. It is used to measure and monitor steroid-toxicity in young patients.The instrument provides weighted scores of steroid-toxicity that equip researchers, clinicians and regulators to evaluate the impact of steroid-sparing treatments. The pGTI is fast, accurate, and easy to implement.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 Clare Pain, leading the trial across the UK, highlighted the potential of this 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 the 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.
Steritas CEO, Martha Stone, said: “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. We are pleased to be part of Dr Pain’s research across the United Kingdom and celebrate this first use of the pGTI - clinical research tool - at point of care. The pGTI, is part of our STOX® Suite of clinical outcome assessments of steroid toxicity which are being used in 80 countries and 1100 trial sites across the world, and in some 28 different diseases. Its first use in clinical practice is an opportunity to catch emerging toxicity before it does lasting harm to patients.”
About Steritas
Steritas is dedicated to enhancing patient care and reducing healthcare costs associated with long-term steroid use and has revolutionized the measurement and monitoring of steroid treatments by developing the first and only clinical outcome assessments (COAs) for steroid-toxicity.
The Steritas STOX® Suite of COAs enables researchers to demonstrate the safety and efficacy of new steroid-sparing therapies and helps clinicians optimize treatment, reduce steroid usage, and improve patient outcomes. The STOX Suite has been deployed at 1100 sites, across 80 countries in more than 28 diseases. Steritas recently launched Sam (Steroids and Me) to educate and equip steroid-treated patients to participate in shared decision-making about their treatment.
For more information, visit the Steritas website: https://www.steritas.com/
To visit Sam, go to https://steroidsandme.com/
About the National Institute for Health and Care Research (NIHR)
The mission of the National Institute for Health and Care Research (NIHR) is to improve the health and wealth of the nation through research. We do this by:
• Funding high quality, timely research that benefits the NHS, public health and social care;
• Investing in world-class expertise, facilities and a skilled delivery workforce to translate discoveries into improved treatments and services;
• Partnering with patients, service users, carers and communities, improving the relevance, quality and impact of our research;
• Attracting, training and supporting the best researchers to tackle complex health and social care challenges;
• Collaborating with other public funders, charities and industry to help shape a cohesive and globally competitive research system;
• Funding applied global health research and training to meet the needs of the poorest people in low and middle income countries.
NIHR is funded by the Department of Health and Social Care. Its work in low-and-middle-income countries is principally funded through UK Aid from the UK government.
Chief Investigators – Associate Professor Clare Pain & Professor Athimalaipet Ramanan.
For more information, please contact Trial Manager: Laura Whitty by sending an email to: star-jia@liverpool.ac.uk