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

August 7, 2023 updated by: Sequenom, Inc.

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
444

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Annapolis, Maryland, United States, 21401
        • Annapolis Rheumatology LLC
      • Baltimore, Maryland, United States, 21215
        • Lifebridge Sinai Hospital of Baltimore
      • Baltimore, Maryland, United States, 21286
        • Rheumatology Associates of Baltimore LLC
      • Catonsville, Maryland, United States, 21228
        • Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC.
      • Columbia, Maryland, United States, 21046
        • Arthritis Care Specialists of Maryland
      • Cumberland, Maryland, United States, 21502
        • Klein & Associates
      • Glen Burnie, Maryland, United States, 21060
        • Mid-Atlantic Rheumatology
      • Greenbelt, Maryland, United States, 20770
        • Arthritis & Pain Associates of PG County
      • Hagerstown, Maryland, United States, 21502
        • Klein & Associates
      • Hollywood, Maryland, United States, 20639
        • MedStar Shah Medical Group
      • Wheaton, Maryland, United States, 20902
        • The Center For Rheumatology And Bone Research

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years and older (Adult, Older Adult)

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Vectra Guided
For patients in the guided care arm, treating physicians will receive the Vectra 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 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
Baseline to 9 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
Baseline to 1 year
Medical Utilization
Time Frame: Baseline to 1 year
Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.).
Baseline to 1 year
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.
Baseline to month 9
Pharmacy Utilization
Time Frame: Baseline to 1 year
Pharmacy utilization metrics (days' supply, prescriptions, etc.).
Baseline to 1 year
Treatment Adherence
Time Frame: Baseline to 1 year
Treatment adherence metrics measured according to medical possession ratio and time to discontinuation.
Baseline to 1 year

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
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:

  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.
Baseline to 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Sequenom, Inc.

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Laboratory Corporation of America

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Elena Hitraya, MD, Consultant

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 22, 2018

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 16, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 16, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 26, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 16, 2019

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
January 18, 2019

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 9, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 128-CL-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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