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

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

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.

Study Overview

• Status: Completed
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Genetic: Vectra MBDA Test

Detailed Description

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 (Actual): 444

Contacts and Locations

Study Locations

• United States
  • Maryland
    • Annapolis, Maryland, United States, 21401
      • Annapolis Rheumatology LLC
    • Baltimore, Maryland, United States, 21215
      • Lifebridge Sinai Hospital of Baltimore
    • Baltimore, Maryland, United States, 21286
      • Rheumatology Associates of Baltimore LLC
    • Catonsville, Maryland, United States, 21228
      • Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC.
    • Columbia, Maryland, United States, 21046
      • Arthritis Care Specialists of Maryland
    • Cumberland, Maryland, United States, 21502
      • Klein & Associates
    • Glen Burnie, Maryland, United States, 21060
      • Mid-Atlantic Rheumatology
    • Greenbelt, Maryland, United States, 20770
      • Arthritis & Pain Associates of PG County
    • Hagerstown, Maryland, United States, 21502
      • Klein & Associates
    • Hollywood, Maryland, United States, 20639
      • MedStar Shah Medical Group
    • Wheaton, Maryland, United States, 20902
      • The Center for Rheumatology and Bone Research

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adults with RA who are currently taking one or more non-biologic DMARD and/or biologic DMARD listed in Appendix 2.

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vectra Guided; 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; Vectra Guided versus Usual Care
Usual Care; 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?

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patients with Non-High MBDA Scores	Proportion of patients with non-high (≤44) MBDA scores from baseline to month 9.	Baseline to month 9
Overall Medical Costs	Overall medical costs, pharmacy costs, RA treatment medication costs, and biologic DMARD medication costs (Appendix 2) from baseline to one year according to: Baseline MBDA score category (low <30, moderate 30-44, high >44).; Whether treatment decisions were consistent with the MBDA score-based treatment guidance in Appendix 1 (guided treatment arm only).; Whether MBDA score category changed from baseline to month 9.; Whether biologic DMARD use was tapered.	Baseline to 1 year

Collaborators and Investigators

• Sponsor: Sequenom, Inc.
• Collaborators: Laboratory Corporation of America
• Investigators: Study Director: Elena Hitraya, MD, Consultant

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2018
• Primary Completion (Actual): August 16, 2022
• Study Completion (Actual): October 16, 2022

Study Registration Dates

• First Submitted: December 26, 2018
• First Submitted That Met QC Criteria: January 16, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): August 9, 2023
• Last Update Submitted That Met QC Criteria: August 7, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Autoimmune Diseases; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Arthritis; Arthritis, Rheumatoid
• Other Study ID Numbers: 128-CL-01

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No