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Changing the way we treat RA patients with PrismRATM

Through a simple blood test, PrismRA could predict non-response to anti-TNF therapies in patients with rheumatoid arthritis, allowing RA patients to receive the right drug from day one.

About 90% of RA patients who fail a DMARD like methotrexate are prescribed anti-TNF biologic therapies, but only about one in three RA patients will respond to these drugs. Those who do not respond are exposed to potentially dangerous side effects all while their diseases progress and they waste money on ineffective prescription costs. Currently, there is no tool to predict which patient will respond to which treatment today, 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 joining the trial and giving a simple blood sample, you can continue to follow your standard of care and help us get PrismRA one step closer today, stopping RA patients from cycling through ineffective treatments tomorrow.

NETWORK-004: Prospective Observational Trial to Validate the Ability of PrismRA to Predict Non-Responders to Anti-TNF Therapies

Overview:

  • Scipher will follow the standard of care for RA patients who fail methotrexate and are starting an anti-TNF therapy
  • Prospective, blinded, observational, open-label multicenter trial conducted in the US; there is no change to the standard of care 
  • Evaluating the clinical performance and utility of PrismRA in biological naïve patients with pre-existing diagnosis of RA 

Primary Endpoint:

Determine the predictive ability of PrismRA to identify anti-TNF therapy non-responders in female and/or all rheumatoid arthritis patients with moderate or high disease activity using standard clinical outcome measures 

Abridged Inclusion/Exclusion Criteria

Inclusion: 

  • 18 years of age or older 
  • Patient with active moderate to severe (CDAI > 10) RA who are biological therapy naïve and eligible for biologic therapy according to ACR guidelines 
  • Swollen and tender joint counts, each ≥4, as determined by CDAI assessment at time of enrollment using a 28-joint count 
  • Patient on oral or subcutaneous methotrexate for at least 12 weeks 
  • Patient willing to receive anti-TNF therapy 

Exclusion: 

  • Women who are known to be pregnant or breast-feeding 
  • Concurrent treatment with an investigational product or use of an investigational product less than 4 weeks from the first study procedure 
  • Intra-articular or parenteral corticosteroids ≤2 weeks prior to the first study procedure 
  • Documented diagnosis of septic arthritis within a native or prosthetic joint ≤12 months from the first study procedure 
  • Active infection of Tuberculosis, Hepatitis B and C, HIV, or other systemic infection