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

Sequenom, Inc.444 enrolled

Overview

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.

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).

Study Type

OBSERVATIONAL

Enrollment

444

Conditions

Rheumatoid Arthritis

Interventions

Vectra MBDA TestGENETIC

Vectra Guided versus Usual Care

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (11)

Annapolis Rheumatology LLC

Annapolis, Maryland, United States

Lifebridge Sinai Hospital of Baltimore

Baltimore, Maryland, United States

Rheumatology Associates of Baltimore LLC

Baltimore, Maryland, United States

Outcomes

Primary Outcomes

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)

Time frame: Baseline to 9 months

Secondary Outcomes

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.

Time frame: Baseline to 1 year

Medical Utilization

Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.).

Time frame: 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.

Time frame: Baseline to month 9

Pharmacy Utilization

Pharmacy utilization metrics (days' supply, prescriptions, etc.).

Time frame: Baseline to 1 year

Treatment Adherence

Treatment adherence metrics measured according to medical possession ratio and time to discontinuation.

Time frame: Baseline to 1 year

Data from ClinicalTrials.gov

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