Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test

Study Overview
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Brief Summary
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Nine months multi-center prospective, randomized observational study, two arm trial to evaluate the effect of MBDA score-guided care on disease activity and medical costs.

Detailed Description
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Nine months multi-center prospective, randomized observational study, two arm trial to evaluate the effect of MBDA score-guided care on disease activity and medical costs. To investigate whether treatment decisions guided by MBDA scores result in reduced disease activity and overall medical cost among patients with RA relative to usual care (UC).

Official Title
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Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test on Clinical Outcomes and Pharmaceutical Utilization in Patients With Rheumatoid Arthritis: A Prospective, Randomized Study

Conditions
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Rheumatoid Arthritis

Intervention / Treatment
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* Genetic: Vectra MBDA Test


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Willing and able to sign an informed consent form (ICF) Age at least 18 years old at screening visit Diagnosed with RA according to 1987 or 2010 criteria of the American College of Rheumatology Actively managed by a CareFirst health care practitioner Currently taking one or more biologic and/or non-biologic DMARDs listed in Appendix 2 Currently has CareFirst medical coverage Exclusion Criteria: Active infection History of malignancy within the past 5 years or any evidence of persistent malignancy, except fully excised basal cell or squamous cell carcinomas of the skin, or cervical carcinoma in situ that has been treated or excised in a curative procedure Current enrollment in another clinical trial On non-biologic DMARD monotherapy or combination therapy with stable disease for ≥6 months Any condition or circumstance that makes it likely the patient will not be able to complete the 9-month trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Vectra Guided<br>For patients in the guided care arm, treating physicians will receive the Vectra MBDA Test score prior to the patient visit and will have a set of guidance for decision-making based on these scores. Treating physicians will be strongly encouraged to follow the guidance but will not be required to do so. For test results to be available at the time of each visit in the MBDA guided treatment arm, blood testing will be performed 7-10 days before the visit. | Genetic: Vectra MBDA Test<br>* Vectra Guided versus Usual Care<br>|
| Usual Care<br>For patients in the UC arm, treating physicians will not have access to MBDA scores until the end of the study. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean MBDA Score | Change in disease activity from baseline to month 9 as measured by mean MBDA score. MBDA Score stands for the Vectra multi-biomarker disease activity (MBDA) blood test. Scale: Low (>30); Moderate (30-44); High (>44) | Baseline to 9 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Overall Medical Costs | Changes in overall medical costs, RA-related medical costs, pharmacy costs, RA treatment medication costs, and biologic DMARD medication costs from baseline to one year, as defined in Appendix 2. | Baseline to 1 year | 
| Medical Utilization | Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.). | Baseline to 1 year | 
| Proportion of Patients who Showed a Response to Medication | Proportion of patients who showed a response to medication, defined as a decrease in MBDA score of at least 8 from baseline to month 9. | Baseline to month 9 | 
| Pharmacy Utilization | Pharmacy utilization metrics (days' supply, prescriptions, etc.). | Baseline to 1 year | 
| Treatment Adherence | Treatment adherence metrics measured according to medical possession ratio and time to discontinuation. | Baseline to 1 year |