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The first and only validated measure of steroid-toxicity

Steritas GTI

Validated clinical outcome assessment of steroid-toxicity

The Steritas GTI provides a systematic approach to assessing steroid-toxicity.  It has been validated and is FDA 21 CFR Part 11 enabled* to measure and monitor steroid-toxicity in clinical trials.

 

The GTI instrument provides weighted outcome scores of steroid-toxicity that equip clinicians and regulators to evaluate the impact of steroid-sparing treatments. The GTI is fast, accurate, and easy to implement.

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 now supports a growing list of therapies in clinical trials and real-world studies.

 

To learn more about licensing the GTI for your next trial, click on the links below:

 

Pharma & Biotech CROs Academia Regulatory
SteritasGTI

Steritas GTI

First-in-class digital instrument1 validated to quantify steroid-toxicity

The Steritas GTI 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 GTI is fast, accurate, and easy to implement.

 

The GTI 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 GTI, becomes of paramount importance. 

Steritas_Core_Index_Damage_Checklist

Capture change in steroid-toxicity over time

The Steritas GTI 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 GTI 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 GTI 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 GTI. 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 GTI 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 GTI 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.

“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.

Contact Us 

Could the Steritas GTI 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

 

1. FDA 21 CFR, Part 11 enabled tools. Software as a Medical Device (SaMD)