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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03810144
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : December 3, 2020
Sponsor:
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Brief Summary:
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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis Genetic: Vectra DA 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).

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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

Resource links provided by the National Library of Medicine


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.
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.



Primary Outcome Measures :
  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 DA multi-biomarker disease activity (MBDA) blood test.

    Scale: Low (>30); Moderate (30-44); High (>44)



Secondary Outcome Measures :
  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 Outcome Measures:
  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:

    1. Baseline MBDA score category (low <30, moderate 30-44, high >44).
    2. Whether treatment decisions were consistent with the MBDA score-based treatment guidance in Appendix 1 (guided treatment arm only).
    3. Whether MBDA score category changed from baseline to month 9.
    4. Whether biologic DMARD use was tapered.



Information from the National Library of Medicine

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

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

Information from the National Library of Medicine

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


Contacts
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Contact: Diana Vogel 801-746-6532 dvogel@myriad.com
Contact: Erica Akins 5134777732 erica.akins@myriad.com

Locations
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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         
Sponsors and Collaborators
Myriad Genetic Laboratories, Inc.
Investigators
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Study Director: Elena Hitraya Crescendo Bioscience, Inc.
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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

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases