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

Sequenom

Status: Completed

Conditions: Rheumatoid Arthritis

Treatments: Genetic: Vectra MBDA Test

Study type: Observational

Funder types: Industry

Identifiers

NCT03810144

128-CL-01

Details and patient eligibility

About

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.

Full 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).

Enrollment: 444 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

444 participants in 2 patient groups

Vectra Guided

Description:

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.

Treatment:

Genetic: Vectra MBDA Test

Usual Care

Description:

For patients in the UC arm, treating physicians will not have access to MBDA scores until the end of the study.