Through a simple blood test, PrismRATM could predict non-response to anti-TNF therapies in patients with rheumatoid arthritis (RA), creating better outcomes for these patients.
About 90% of RA patients who fail a DMARD like methotrexate are prescribed anti-TNF therapies, but only about 1 in 3 RA patients will respond to these drugs. Those who do not respond are exposed to potentially dangerous side effects, disease progression, and high costs of prescriptions that do not work for them.
Currently, there is no tool to predict which patient will respond to which treatment, so patients are being treated uniformly rather than based on their unique disease biology.
It’s time to stop treating all RA patients the same and create a treatment road map unique to each individual. By becoming a trial site and collecting small blood samples, physicians can continue to treat per their standard of care and help us validate PrismRATM.
The goal of this trial, called NETWORK-004, is to determine the clinical utility of PrismRATM. The trial follows standard of care, plus four (4) additional blood samples, for patients who fail methotrexate and are about to initiate their first anti-TNF.
How the test works:
By analyzing RNA from a patient’s blood sample, PrismRATM can predict response to an anti-TNF before a patient starts their first biologic.
Patients and their rheumatologists will be blinded to results over the course of the trial.
Below is a list of questions that are frequently asked for your reference.
PrismRATM is a blood test currently in clinical trials that predicts non-response to anti-TNFs in rheumatoid arthritis patients prior to treatment initiation. Patients who do not respond can gain access to other approved medications that may be more effective sooner.
Roughly two-thirds of RA patients prescribed anti-TNFs fail to respond adequately.By targeting anti-TNFs, we can help more patients reach meaningful clinical changes more quickly while avoiding unnecessary side effects, disease progression, and high prescription consts.
The primary endpoint of this study is the predictive ability of the PrismRATM response classifier to identify anti-TNF non-responders in female and/or all rheumatoid arthritis patients with moderate or high disease activity, using standard clinical outcome measures (CDAI, ACR50, DAS-28).
NETWORK-004 is an open-label, blinded, multi-center study. It is being conducted at institutions entirely within the US.
The target number is 200 evaluable patients from approximately 225 enrolled.
Yes. In order to support non-biased treatment, all investigators will remain blinded to the results of the PrismRATM response classification.
Yes. PrismRATM is not marketed or approved within the US. Any results predicted by the sponsor are research-use-only and therefore may not be shared with patients.
There are 4 visits throughout the study.
No. This study is observational, tracking standard of care. The study sponsor will not cover any anti-TNF medication costs associated with the study.
Yes. Particularly for infliximab, which has several marketed biosimilars within the US.
Yes. Patients must be 18 years of age or older. The study is not accepting juvenile patients.
Moderate to severe rheumatoid arthritis
Yes. More broadly, patients must be naïve to (i.e. they have never taken) biologics, regardless of class or indication. They must also be naïve to targeted synthetic DMARDs (e.g. tofacitinib).
Yes. Patients must be on methotrexate for at least 10 weeks prior to enrollment and must be on a stable dose for at least 4 weeks prior to enrollment. Methotrexate must be continued at a stable dose throughout the study.
Yes. Patients must be on the combination for at least 10 weeks prior to enrollment and must be on a stable dose for at least 4 weeks prior to enrollment. The combination must be continued at stable doses throughout the study.
No. Sulfasalazine is not a permitted medication. Patients must not have taken sulfasalazine within the 10 weeks prior to enrollment.
This page is for U.S. healthcare providers only.