PrismRATM Trial

Become a Trial Site

Changing the way we treat RA patients with PrismRATM

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.

Overview:

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.

Inclusion criteria

  • Patient is 18 years of age, or older (≥18) at time of first study procedure
    Patient has active, moderate to severe (CDAI > 10) RA
  • Patient is biologic therapy naïve (to include all biologics and targeted therapies, regardless of class or
    indication) and eligible for biologic therapy
  • Patient is initiating first anti-TNF therapy (FDA approved and marketed in the US)
  • Patient has a swollen joint count ≥ 4, as determined by assessment at time of enrollment using a 28-joint count
  • Patient has a combined tender and swollen joint count ≥ 8, as determined by assessment at time of enrollment
    using a 28-joint count
  • Patient has been on oral or subq MTX for at least 10 weeks with a stable MTX dose of ≥15 – 25 mg/week
    (maximum 25 mg/week) in the 4 weeks before the first study procedure. Doses as low as 10mg/week are
    acceptable if the patient has documented intolerance to higher doses.
  • Doses of hydroxychloroquine (HCQ) not exceeding 400 mg/day or leflunomide not exceeding 20 mg/day for at least 10 weeks prior to baseline visit, with a stable dose at least 4 weeks prior to baseline visit are allowable in
    combination with MTX
  • Patient will continue stable doses of MTX and other allowable csDMARDs throughout the study
  • Patient may be on daily folate or weekly leucovorin as part of standard of care

Exclusion Criteria

  • Women who are known to be pregnant or breast-feeding. Any subject unwilling to use effective contraception
  • Use of any bDMARD or tsDMARD (e.g. tofacitinib) at any time prior to Visit 1
  • Use of any csDMARDs in the 10 weeks prior to Visit 1 other than MTX, HCQ, or leflunomide
    Concurrent treatment with an investigational product or use of an investigational product less than 4 weeks from the first study procedure
  • Use of intra-articular or parenteral corticosteroids within the last 2 weeks prior to the first study procedure.
    Stable doses of prednisone ≤ 10 mg/day for at least 4 weeks prior to baseline are allowable
  • Documented history of active or latent TB infection without completing adequate antibiotic prophylaxis
  • Currently receiving systemic antimicrobial treatment for viral, bacterial, fungal or parasitic infections at the time of the first study procedure (does not include routine prophylaxis).
    Known HIV or hepatitis B/C infection
  • Documented history of septic arthritis within a native joint ≤ 12 months from the first study procedure
  • Sepsis of a prosthetic joint ≤ 12 months from the first study procedure or indefinitely if the joint remains in situ
  • Documented history of demyelinating disease
  • Documented history of a cerebral vascular event (stroke), unstable angina, myocardial infarction, or cardiac symptoms (including congestive heart failure) consistent with New York Heart Association
  • Class III-IV within 6 months prior to the study procedure
  • History of malignancy ≤ 3 years before the first study procedure or has evidence of residual disease from a previously diagnosed malignancy.
  • Patients with non-melanoma skin cancer, localized prostate cancer treated with curative intent with no evidence of progression, low-risk or very low-risk (per standard guidelines) localized prostate cancer under surveillance/watchful waiting (without intent to treat), or carcinoma in situ of any type (completely resected) are allowed
  • Documented history of lymphoma at any time
  • Receipt of any vaccine at any point after Visit 1 and for the duration of the study (i.e. live-attenuated, inactivated, toxoid, and all other vaccination types are prohibited)
  • Any other contra-indication to the study medications as detailed in their summaries of product characteristics
    Any other underlying medical condition that, in the opinion of the investigator, would impair the ability of the patient to receive or tolerate the planned procedures or complete the follow up requirements

Frequently Asked Questions

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.

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.