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



Status:Recruiting
Conditions:Arthritis, Rheumatoid Arthritis
Therapuetic Areas:Rheumatology
Healthy:No
Age Range:18 - Any
Updated:1/20/2019
Start Date:October 22, 2018
End Date:December 2019
Contact:Stacy Meluskey
Email:smeluskey@myriad.com
Phone:510-258-9079

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Impact of Guided Care With the Vectra DA 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, site randomized, two arm trial to evaluate the effect
of MBDA score-guided care on disease activity and medical costs.

Nine months multi-center prospective, site randomized, 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).

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

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
We found this trial at
3
sites
Wheaton, Maryland 20902
Principal Investigator: Alan K Matsumoto, MD
Phone: 301-942-6610
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Wheaton, MD
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Columbia, Maryland 21046
Principal Investigator: Thomas Lang, MD
Phone: 410-992-7440
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Columbia, MD
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Hagerstown, Maryland 21740
Principal Investigator: Mary Howell, MD
Phone: 301-791-6680
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Hagerstown, MD
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