Impact of Guided Care With the Vectra DA Multi-biomarker Disease Activity (MBDA) Blood Test (CareFirst)
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ClinicalTrials.gov Identifier: NCT03810144 |
Recruitment Status :
Recruiting
First Posted : January 18, 2019
Last Update Posted : December 3, 2020
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Condition or disease | Intervention/treatment |
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Rheumatoid Arthritis | Genetic: Vectra DA MBDA Test |
Study Type : | Observational |
Estimated Enrollment : | 500 participants |
Observational Model: | Cohort |
Time Perspective: | Prospective |
Official Title: | 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 |
Actual Study Start Date : | October 22, 2018 |
Estimated Primary Completion Date : | March 2021 |
Estimated Study Completion Date : | March 2021 |

Group/Cohort | Intervention/treatment |
---|---|
Vectra Guided
For patients in the guided care arm, treating physicians will receive the Vectra DA 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.
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Genetic: Vectra DA 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.
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- 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 DA multi-biomarker disease activity (MBDA) blood test.
Scale: Low (>30); Moderate (30-44); High (>44)
- 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.
- Medical Utilization [ Time Frame: Baseline to 1 year ]Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.).
- 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.
- Pharmacy Utilization [ Time Frame: Baseline to 1 year ]Pharmacy utilization metrics (days' supply, prescriptions, etc.).
- Treatment Adherence [ Time Frame: Baseline to 1 year ]Treatment adherence metrics measured according to medical possession ratio and time to discontinuation.
- 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.
- 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03810144
Contact: Diana Vogel | 801-746-6532 | dvogel@myriad.com | |
Contact: Erica Akins | 5134777732 | erica.akins@myriad.com |
United States, Maryland | |
Annapolis Rheumatology LLC | Recruiting |
Annapolis, Maryland, United States, 21401 | |
Contact: Shakeara Collins 410-897-1941 ext 1119 arheumatologyscollins@gmail.com | |
Principal Investigator: Heidi Sami, MD | |
Lifebridge Sinai Hospital of Baltimore | Terminated |
Baltimore, Maryland, United States, 21215 | |
Rheumatology Associates of Baltimore LLC | Active, not recruiting |
Baltimore, Maryland, United States, 21286 | |
Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC. | Not yet recruiting |
Catonsville, Maryland, United States, 21228 | |
Contact: Samantha Mihm 410-744-0661 smihm@nassericlinic.com | |
Contact: Sahar Nemati 410-744-0661 snemati@nassericlinic.com | |
Principal Investigator: Nasser Nasseri-Asl, M.D. | |
Arthritis Care Specialists of Maryland | Recruiting |
Columbia, Maryland, United States, 21046 | |
Contact: Robyn Bell, CCMA 410-992-7440 acsmresearch@gmail.com | |
Principal Investigator: Thomas Lang, MD | |
Klein & Associates | Recruiting |
Cumberland, Maryland, United States, 21502 | |
Contact: Mary Welsh 301-724-4337 mwelsh@rheumdocs.com | |
Principal Investigator: Steven Klein, MD | |
Mid-Atlantic Rheumatology | Recruiting |
Glen Burnie, Maryland, United States, 21060 | |
Contact: Holly Moores 410-787-9400 | |
Principal Investigator: Erinn Maury, MD | |
Arthritis & Pain Associates of PG County | Recruiting |
Greenbelt, Maryland, United States, 20770 | |
Contact: Millie Forbes 301-345-5600 mforbes@apapgc.com | |
Principal Investigator: Yevgeniy Sheyn, M.D. | |
Klein & Associates | Recruiting |
Hagerstown, Maryland, United States, 21502 | |
Contact: Stephanie Melton 301-791-6680 ext 1144 smelton@rheumdocs.com | |
Principal Investigator: Mary Howell, MD | |
Sub-Investigator: Steven Klein, MD | |
MedStar Shah Medical Group | Recruiting |
Hollywood, Maryland, United States, 20639 | |
Contact: Melissa Harris 301-373-7558 melissa.renee.harris@medstar.net | |
Principal Investigator: Kundan Karkhanis, M.D. | |
The Center for Rheumatology and Bone Research | Recruiting |
Wheaton, Maryland, United States, 20902 | |
Contact: Ashling Bauer, BA 301-942-6610 abauer@arapc.com | |
Principal Investigator: Alan K Matsumoto, MD | |
Sub-Investigator: Herbert SB Baraf, MD, FACP | |
Sub-Investigator: Robert L Rosenberg, MD, FACR | |
Sub-Investigator: Evan L Siegel, MD, FACR | |
Sub-Investigator: Nicole S Thomas, MD, FACR | |
Sub-Investigator: Grace E Ahn, MD, FACR | |
Sub-Investigator: Jeffrey A Potter, MD, FACR | |
Sub-Investigator: Grant H Louie, MD |
Study Director: | Elena Hitraya | Crescendo Bioscience, Inc. |
Responsible Party: | Myriad Genetic Laboratories, Inc. |
ClinicalTrials.gov Identifier: | NCT03810144 |
Other Study ID Numbers: |
128-CL-01 |
First Posted: | January 18, 2019 Key Record Dates |
Last Update Posted: | December 3, 2020 |
Last Verified: | December 2020 |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Arthritis Arthritis, Rheumatoid Joint Diseases Musculoskeletal Diseases |
Rheumatic Diseases Connective Tissue Diseases Autoimmune Diseases Immune System Diseases |