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The first composite measure of steroid-toxicity in children

Steritas pGTI

Validated clinical outcome assessment of steroid-toxicity

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 pGTI 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.

 

Glucocorticoids can severely impact growth and development in children, lead to adverse events in puberty, and can affect overall wellness throughout adulthood. To fully address these impairments, the pGTI:

  • includes growth as an entirely new domain.
  • considers age-related references such as height, and gender-specific reference ranges for blood pressure and for other parameters.
  • assesses neurological side effects unique to the pediatric population.
  • adjusts domain weights to score those steroid-toxicities that are specific to children.

It’s time to get steroid-sparing in the label

Regulatory agencies such as the U.S. Food & Drug Administration and European Medicines Agency view steroid reduction as a reflection of both efficacy and safety. 

 

Reduction in steroid-toxicity as measured by the Steritas GTI constituted the key secondary endpoint in the ADVOCATE Trial. The FDA granted approval to avacopan for the treatment of ANCA-associated vasculitis. The GTI and pGTI now support a growing list of therapies in clinical trials and real-world studies.

 

To learn more about licensing the pGTI, click on the links below:

 

Pharma & Biotech CROs Academia Regulatory
SteritasGTI

Steritas pGTI

First-in-class digital instrument validated to quantify steroid-toxicity in children

The Steritas pGTI is a systematic approach to assessing steroid-toxicity and informing decision making in the treatment of inflammatory diseases. The instrument provides weighted outcome scores of steroid-toxicity that equip clinicians and regulators to evaluate the impact of steroid-sparing treatments. The pGTI is fast, accurate, and easy to implement.

 

The pGTI provides the only clinical outcome assessment (COA) that drug developers can rely on to demonstrate improved safety of their new treatment compared to steroids alone. When a new therapy is shown to be non-inferior to standard therapy with regard to efficacy, the safety of the new agent, as measured by the pGTI, becomes of paramount importance. 

Steritas_Core_Index_Damage_Checklist

Capture change in steroid-toxicity over time

The Steritas pGTI is comprised of two components: the Core Index and the Damage Checklist. The Core Index is built on nine domains that are standardized and weighted to quantify and compare indicators of toxicity that may occur over the course of a clinical trial. The Damage Checklist is an inventory of steroid toxicities that are less common yet are often severe and generally reflect permanent damage from prior steroid use. The pGTI merges these two components in an intuitive workflow that aligns with the normal course of data collection in a clinic visit.

Steritas_SteriToxProfile_CWS_AIS

Monitor your clinical trial patients with their SteriTox profile.

The Steritas pGTI provides a nuanced view of patient results, which are summarized in the SteriTox Profile for each patient. The Cumulative Worsening Score (CWS), and the Aggregate Improvement Score (AIS), summarize all of the data entered into the pGTI. Higher scores indicate higher toxicity (worsening); lower scores indicate lower toxicity (improvement). Therefore, if an investigational treatment is effective in decreasing steroid-toxicity over time, the CWS and AIS will be lower in the investigational arm of the trial.

Designed for ease-of-use at all points of patient communication

The pGTI balances rigorous data analytics with an intuitive data entry process that simplifies use for everyone that collects patient data during the course of a clinical trial.

 

Each patient visit can be recorded in just a few minutes. Data entry can be entered all at once or as patient data become available. Your patient’s SteriTox Profile is reported as soon as all required modules are complete.

 

The pGTI workflow:

  • Maximizes efficiency by leveraging individual roles and expertise. Five modules are entered by the trial coordinator or nurse and four by the physician investigator.
  • Ensures data entry accuracy with prompts at each step and notifications of missing data.
  • Saves time by avoiding redundancy in data capture and enabling cross-referencing between elements of the trial database.
HubSpot Video

 

 

 

“What you gain by adding the Steritas GTI to a clinical trial is a systematic way of assessing steroid-toxicity.”

 

 

David Jayne, MD
Professor of Clinical Autoimmunity, University of Cambridge
and Director, Vasculitis and Lupus Service, Addenbrooke’s Hospital

“If the Glucocorticoid Toxicity Index were part of a Target Product Profile (TPP) in a clinical development program it could really help capture the benefit of a new therapy that reduces steroid-related toxicity as steroid dosage is also reduced. Again, the key elements of the TPP are efficacy, safety, dosage and administration."

Paul Brunetta, MD
Head of Clinical & Translational Science, Sana Biotechnology
Adjunct Associate Professor, Pulmonary and Critical Care Division,
University of California, San Francisco

"Being able to show in a clinical trial that you can decrease the effects of glucocorticoid toxicity is a huge step in terms of being an additional end-point not only from the standpoint of drug approval, but also from the context of making it more understandable for clinicians and physicians in terms of how a drug can have benefit."

Sudhakar Sridharan, MD
Vice President, Global Product Development, Imm/Rheum/Inflam/Clinical Research
PPD, part of ThermoFisher Scientific

GTI and pGTI licenses are tailored to the design of your clinical trial.

We welcome your interest in the Steritas GTI and pGTI. All uses of these instruments require a license, whether you are an academic researcher, biotech start-up, a large pharmaceutical company, or a clinical research organization.

 

Steritas will structure a use license to support the scope and design of your trial and the needs of your organization.

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Could the Steritas pGTI be a useful efficacy and safety outcome measure in your next clinical trial?

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The Steritas GTI in clinical trials

Steroid-toxicity is being measured in a growing list of clinical trials for inflammatory disease drug candidates.

The Steritas GTI provides a definitive outcome measure for clinical investigators to compare efficacy and safety of new drug protocols to conventional steroid therapies. In recent clinical trials that resulted in FDA approval of avacopan as an add-on treatment to standard therapy including glucocorticoids for adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis, glucocorticoid-induced toxic effects were secondary endpoints of the trial, as measured by both the GTI-CWS and GTI-AIS. Additional clinical trials are underway that are using the Steritas GTI to support primary and secondary safety endpoints.

View a list of trials