Status:
COMPLETED
Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test
Lead Sponsor:
Sequenom, Inc.
Collaborating Sponsors:
Laboratory Corporation of America
Conditions:
Rheumatoid Arthritis
Eligibility:
All Genders
18+ years
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 treat...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 22 2018
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
October 16 2022
Estimated Enrollment :
444 Patients enrolled
Trial Details
Trial ID
NCT03810144
Start Date
October 22 2018
End Date
October 16 2022
Last Update
August 9 2023
Active Locations (11)
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1
Annapolis Rheumatology LLC
Annapolis, Maryland, United States, 21401
2
Lifebridge Sinai Hospital of Baltimore
Baltimore, Maryland, United States, 21215
3
Rheumatology Associates of Baltimore LLC
Baltimore, Maryland, United States, 21286
4
Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC.
Catonsville, Maryland, United States, 21228