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

Description

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.

Conditions

Rheumatoid Arthritis (RA)

Study Overview

Study Details

Study overview

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.

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

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

Condition
Rheumatoid Arthritis (RA)
Intervention / Treatment

-

Contacts and Locations

La Mesa

Bio Solutions Clinical Research, La Mesa, California, United States, 91942

Murrieta

Brigid Freyne, MD, Murrieta, California, United States, 92563

Orange

J. Lee MD Medical Corp, Orange, California, United States, 92868

Lewes

Delaware Arthritis, Lewes, Delaware, United States, 19958

Aventura

AARDS Research, Inc., Aventura, Florida, United States, 33180

Clearwater

Robert W. Levin, MD, PA, Clearwater, Florida, United States, 33765

Miami

Artemisa Analytics, Miami, Florida, United States, 33133

Orlando

Rheumatology Associates of Central Florida, P.A., Orlando, Florida, United States, 32806

South Miami

Clin-Med Research & Development, LLC, South Miami, Florida, United States, 33141

Lake Charles

Accurate Clinical Research, Lake Charles, Louisiana, United States, 70605

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * ≥ 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
  • * 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Sequenom, Inc.,

Elena Hitraya, MD, STUDY_DIRECTOR, Consultant

Jeffrey R. Curtis, MD, MPH, PRINCIPAL_INVESTIGATOR, University of Alabama at Birmingham

Study Record Dates

2025-09-15