The Effect of Guided Care With Vectra Compared to Treatment as Usual in Patients With Rheumatoid Arthritis

Completed

Conditions studied: Rheumatoid Arthritis (RA)

In brief

The goal of treating patients diagnosed with rheumatoid arthritis (RA) is to achieve remission or low disease activity and thereby prevent joint damage, loss of physical function, and disability. Optimal management requires regular assessment of disease activity, with treatment changes made as needed for optimal efficacy. Vectra is a blood serum test that looks at 12 biomarkers and produces a score on a scale of 1 to 100. The Vectra score has been shown to be the strongest predictor of risk for progression of disease. There is opportunity to gain more information about the utility of Vectra in a real-world clinical setting. This study will, therefore, evaluate the utility of Vectra for guiding treatment decisions and improving RA-related outcomes in comparison with usual care, which will not include Vectra testing. This study will enable a direct evaluation of the clinical benefit associated with using Vectra to guide treatment decisions in patients with RA.

Key facts

Study ID

NCT03631225

Run by

Sequenom, Inc.

People needed

1500

Starts

2019-06-25

Expected to finish

2026-07-15

Last updated by the study team

2026-07-21

Who can join

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

You may qualify if…

• ≥ 18 years old at screening visit
• Diagnosed with RA according to 1987 or 2010 criteria of the American College of Rheumatology
• At the time of the pre-baseline visit, patient has a CDAI score of >10
• Currently taking one or more non-biologic or biologic DMARD at screening and for at least the 3 months prior to screening
• Visit at time of screening scheduled as part of routine care
• Subject and/or physician willing to consider treatment change at screening
• No expectation of imminent treatment change at screening or baseline visit

You may not qualify if…

• Currently taking an anti-IL-6R drug (tocilizumab, sarilumab)
• Any contraindication, administrative barrier, or financial limitation (e.g. no insurance coverage) that makes it impossible for subject to receive at least one new biologic or JAKi therapy for RA
• 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
• Any condition or circumstance that makes it likely the patient will not be able to complete the trial

Where it is running

• Bio Solutions Clinical Research — La Mesa, California, United States
• Brigid Freyne, MD — Murrieta, California, United States
• J. Lee MD Medical Corp — Orange, California, United States
• Delaware Arthritis — Lewes, Delaware, United States
• AARDS Research, Inc. — Aventura, Florida, United States
• Robert W. Levin, MD, PA — Clearwater, Florida, United States
• Artemisa Analytics — Miami, Florida, United States
• Rheumatology Associates of Central Florida, P.A. — Orlando, Florida, United States
• Clin-Med Research & Development, LLC — South Miami, Florida, United States
• Accurate Clinical Research — Lake Charles, Louisiana, United States
• Arthritis and Diabetes Clinic, Inc. — Monroe, Louisiana, United States
• North Mississippi Medical Center — Tupelo, Mississippi, United States
• Clinvest Research, LLC. — Springfield, Missouri, United States
• Rheumatology Associates of Long Island — Smithtown, New York, United States
• Paramount Medical Research & Consulting, LLC — Middleburg Heights, Ohio, United States
• Southern Ohio Rheumatology Inc. — Wheelersburg, Ohio, United States
• East Penn Rheumatology Associates, P.C. — Bethlehem, Pennsylvania, United States
• Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States
• Advanced Rheumatology & Arthritis Research Center, PC — Wexford, Pennsylvania, United States
• PA Regional Center for Arthritis and Osteoporosis Research — Wyomissing, Pennsylvania, United States
• Carolina Health Specialists — Myrtle Beach, South Carolina, United States
• Accurate Clinical Research — Baytown, Texas, United States
• Pioneer Research Solutions, Inc — Cypress, Texas, United States
• Accurate Clinical Research — Houston, Texas, United States
• CardioVoyage — Sherman, Texas, United States

Full record on ClinicalTrials.gov

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