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NCT Number: NCT03810144

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

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.

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Key information

Conditions

Rheumatoid Arthritis Arthritis Arthritis, Rheumatoid Autoimmune Diseases Connective Tissue Diseases Immune System Diseases Joint Diseases Musculoskeletal Diseases Rheumatic Diseases Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Annapolis Rheumatology LLC, Annapolis, Maryland, United States

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About this 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. 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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Vectra MBDA Test

Genetic

Vectra Guided versus Usual Care

Primary outcomes

  1. Mean MBDA Score

    Time frame: Baseline to 9 months

    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)

Secondary outcomes

  1. Changes in Overall Medical Costs

    Time frame: Baseline to 1 year

    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.

  2. Medical Utilization

    Time frame: Baseline to 1 year

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

  3. Proportion of Patients who Showed a Response to Medication

    Time frame: Baseline to month 9

    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.

  4. Pharmacy Utilization

    Time frame: Baseline to 1 year

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

  5. Treatment Adherence

    Time frame: Baseline to 1 year

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

Other outcomes

  1. Proportion of Patients with Non-High MBDA Scores

    Time frame: Baseline to month 9

    Proportion of patients with non-high (≤44) MBDA scores from baseline to month 9.

  2. Overall Medical Costs

    Time frame: Baseline to 1 year

    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.

Sponsors and collaborators

Lead sponsor

Sequenom, Inc.

Industry

Collaborators

  • Laboratory Corporation of America

Registry information

Official study title

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

Acronym: CareFirst

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 18, 2019
Registry last updated
Aug 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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