Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test
- Conditions
- Rheumatoid Arthritis
- Interventions
- Genetic: Vectra MBDA Test
- Registration Number
- NCT03810144
- Lead Sponsor
- Sequenom, 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.
- 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).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 444
- 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
- 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 & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Vectra Guided Vectra MBDA Test 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.
- Primary Outcome Measures
Name Time Method Mean MBDA Score 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)
- Secondary Outcome Measures
Name Time Method Proportion of Patients who Showed a Response to Medication 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.
Treatment Adherence Baseline to 1 year Treatment adherence metrics measured according to medical possession ratio and time to discontinuation.
Medical Utilization Baseline to 1 year Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.).
Changes in Overall Medical Costs 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.
Pharmacy Utilization Baseline to 1 year Pharmacy utilization metrics (days' supply, prescriptions, etc.).
Trial Locations
- Locations (10)
MedStar Shah Medical Group
🇺🇸Hollywood, Maryland, United States
The Center for Rheumatology and Bone Research
🇺🇸Wheaton, Maryland, United States
Klein & Associates
🇺🇸Hagerstown, Maryland, United States
Mid-Atlantic Rheumatology
🇺🇸Glen Burnie, Maryland, United States
Annapolis Rheumatology LLC
🇺🇸Annapolis, Maryland, United States
Lifebridge Sinai Hospital of Baltimore
🇺🇸Baltimore, Maryland, United States
Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC.
🇺🇸Catonsville, Maryland, United States
Arthritis Care Specialists of Maryland
🇺🇸Columbia, Maryland, United States
Rheumatology Associates of Baltimore LLC
🇺🇸Baltimore, Maryland, United States
Arthritis & Pain Associates of PG County
🇺🇸Greenbelt, Maryland, United States