Trials

Let's Help More Patients Reach Remission

Changing the way we treat RA patients

The journey of reaching low disease activity (LDA) or remission is unique to each individual patient because RA is a complicated disease. Yet, about 90% of RA patients who fail a DMARD like methotrexate are prescribed an anti-TNF biologic therapy, even though only about one in three RA patients will reach LDA or remission on these drugs. Those who do not respond to these drugs are exposed to potentially dangerous side effects and disease progression while wasting money on ineffective prescription costs 

It’s time to stop treating all RA patients the same and create a treatment road map unique to them.  

PrismRATM

A simple blood test to Predict Non-Response to Anti-TNF Therapies for Patients with RA.

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.

The need for a test to help rheumatologists avoid prescribing anti-TNF therapy to patients who will not respond, allowing these patients to start alternative approved targeted therapies earlier to help reach LDA is clear. PrismRA is a blood test being developed to meet such a need and is now ready to be studied in the clinic.  

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 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