Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test
CareFirst
1 other identifier
observational
444
1 country
11
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Oct 2018
Longer than P75 for all trials
11 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 22, 2018
CompletedFirst Submitted
Initial submission to the registry
December 26, 2018
CompletedFirst Posted
Study publicly available on registry
January 18, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 16, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 16, 2022
CompletedAugust 9, 2023
August 1, 2023
3.8 years
December 26, 2018
August 7, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Mean MBDA Score
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 Outcomes (5)
Changes in Overall Medical Costs
Baseline to 1 year
Medical Utilization
Baseline to 1 year
Proportion of Patients who Showed a Response to Medication
Baseline to month 9
Pharmacy Utilization
Baseline to 1 year
Treatment Adherence
Baseline to 1 year
Other Outcomes (2)
Proportion of Patients with Non-High MBDA Scores
Baseline to month 9
Overall Medical Costs
Baseline to 1 year
Study Arms (2)
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.
Usual Care
For patients in the UC arm, treating physicians will not have access to MBDA scores until the end of the study.
Interventions
Eligibility Criteria
Adults with RA who are currently taking one or more non-biologic DMARD and/or biologic DMARD listed in Appendix 2.
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
- Laboratory Corporation of Americacollaborator
Study Sites (11)
Annapolis Rheumatology LLC
Annapolis, Maryland, 21401, United States
Lifebridge Sinai Hospital of Baltimore
Baltimore, Maryland, 21215, United States
Rheumatology Associates of Baltimore LLC
Baltimore, Maryland, 21286, United States
Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC.
Catonsville, Maryland, 21228, United States
Arthritis Care Specialists of Maryland
Columbia, Maryland, 21046, United States
Klein & Associates
Cumberland, Maryland, 21502, United States
Mid-Atlantic Rheumatology
Glen Burnie, Maryland, 21060, United States
Arthritis & Pain Associates of PG County
Greenbelt, Maryland, 20770, United States
Klein & Associates
Hagerstown, Maryland, 21502, United States
MedStar Shah Medical Group
Hollywood, Maryland, 20639, United States
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Elena Hitraya, MD
Consultant
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 26, 2018
First Posted
January 18, 2019
Study Start
October 22, 2018
Primary Completion
August 16, 2022
Study Completion
October 16, 2022
Last Updated
August 9, 2023
Record last verified: 2023-08