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The Effect of Guided Care With Vectra Compared to Treatment as Usual in Patients With Rheumatoid Arthritis
Sponsor: Sequenom, Inc.
Summary
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.
Official title: Vectra InVolved Informed Decision Outcome Study (VIVID): A Prospective Randomized Controlled Trial Evaluating the Effect of Guided Care With Vectra Compared to Treatment as Usual in Patients With Rheumatoid Arthritis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
OBSERVATIONAL
Enrollment
1500
Start Date
2019-06-25
Completion Date
2026-04-15
Last Updated
2025-11-06
Healthy Volunteers
No
Conditions
Interventions
Vectra
Each arm will have the Vectra test however, scores will not be provided for the Usual Care Arm until end of study (12 month time point)
Locations (30)
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
Center for Arthritis and Rheumatic Diseases, P.C.
Chesapeake, Virginia, United States
Arthritis and Osteoporosis Center of Northern Virginia
Manassas, Virginia, United States
Center for Arthritis and Rheumatic Diseases., P.C.
Suffolk, Virginia, United States
Arthritis Northwest, PLLC
Spokane, Washington, United States
Aurora Rheumatology and Immunotherapy Center
Franklin, Wisconsin, United States