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

Completed

Conditions studied: Rheumatoid Arthritis

In brief

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.

Key facts

Study ID

NCT03810144

Run by

Sequenom, Inc.

People needed

444

Starts

2018-10-22

Expected to finish

2022-10-16

Last updated by the study team

2023-08-09

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

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

Where it is running

• Annapolis Rheumatology LLC — Annapolis, Maryland, United States
• Lifebridge Sinai Hospital of Baltimore — Baltimore, Maryland, United States
• Rheumatology Associates of Baltimore LLC — Baltimore, Maryland, United States
• Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC. — Catonsville, Maryland, United States
• Arthritis Care Specialists of Maryland — Columbia, Maryland, United States
• Klein & Associates — Cumberland, Maryland, United States
• Mid-Atlantic Rheumatology — Glen Burnie, Maryland, United States
• Arthritis & Pain Associates of PG County — Greenbelt, Maryland, United States
• Klein & Associates — Hagerstown, Maryland, United States
• MedStar Shah Medical Group — Hollywood, Maryland, United States
• The Center for Rheumatology and Bone Research — Wheaton, Maryland, United States

Full record on ClinicalTrials.gov

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