Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : January 18, 2019
Sponsor:
Information provided by (Responsible Party):
Myriad Genetic Laboratories, Inc.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Rheumatoid Arthritis Genetic: Vectra DA MBDA Test Not Applicable

Detailed Description:
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).

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 440 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: 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 1 week before the visit.
 Genetic: Vectra DA MBDA Test
Vectra Guided versus Usual Care
No Intervention: Usual Care
For patients in the UC arm, treating physicians will not have access to MBDA scores until the end of the study.


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Stacy Meluskey 510-258-9079 smeluskey@myriad.com

Locations
Layout table for location information
United States, Maryland
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
Hagerstown, Maryland, United States, 21502
Contact: Christina Chyr, BA    301-791-6680 ext 1144    cchyr@rheumdocs.com   
Principal Investigator: Mary Howell, MD         
Sub-Investigator: Steven Klein, MD         
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.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal information
Responsible Party: Myriad Genetic Laboratories, Inc.
ClinicalTrials.gov Identifier: NCT03810144     History of Changes
Other Study ID Numbers: 128-CL-01
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases