ACTIVE_NOT_RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2019-06-25
Study Completion:2026-04-15
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT03631225

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * ≥ 18 years old at screening visit
  2. * Diagnosed with RA according to 1987 or 2010 criteria of the American College of Rheumatology
  3. * At the time of the pre-baseline visit, patient has a CDAI score of \>10
  4. * Currently taking one or more non-biologic or biologic DMARD at screening and for at least the 3 months prior to screening
  5. * Visit at time of screening scheduled as part of routine care
  6. * Subject and/or physician willing to consider treatment change at screening
  7. * No expectation of imminent treatment change at screening or baseline visit
  1. * Currently taking an anti-IL-6R drug (tocilizumab, sarilumab)
  2. * 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
  3. * Active infection
  4. * 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
  5. * Current enrollment in another clinical trial
  6. * Any condition or circumstance that makes it likely the patient will not be able to complete the trial

Contacts and Locations

Study Locations (Sites)

Bio Solutions Clinical Research
La Mesa, California, 91942
United States
Brigid Freyne, MD
Murrieta, California, 92563
United States
J. Lee MD Medical Corp
Orange, California, 92868
United States
Delaware Arthritis
Lewes, Delaware, 19958
United States
AARDS Research, Inc.
Aventura, Florida, 33180
United States
Robert W. Levin, MD, PA
Clearwater, Florida, 33765
United States
Artemisa Analytics
Miami, Florida, 33133
United States
Rheumatology Associates of Central Florida, P.A.
Orlando, Florida, 32806
United States
Clin-Med Research & Development, LLC
South Miami, Florida, 33141
United States
Accurate Clinical Research
Lake Charles, Louisiana, 70605
United States
Arthritis and Diabetes Clinic, Inc.
Monroe, Louisiana, 71203
United States
North Mississippi Medical Center
Tupelo, Mississippi, 38801
United States
Clinvest Research, LLC.
Springfield, Missouri, 65810
United States
Rheumatology Associates of Long Island
Smithtown, New York, 11787
United States
Paramount Medical Research & Consulting, LLC
Middleburg Heights, Ohio, 44130
United States
Southern Ohio Rheumatology Inc.
Wheelersburg, Ohio, 45694
United States
East Penn Rheumatology Associates, P.C.
Bethlehem, Pennsylvania, 18015
United States
Altoona Center for Clinical Research
Duncansville, Pennsylvania, 16635
United States
Advanced Rheumatology & Arthritis Research Center, PC
Wexford, Pennsylvania, 15090
United States
PA Regional Center for Arthritis and Osteoporosis Research
Wyomissing, Pennsylvania, 19610
United States
Carolina Health Specialists
Myrtle Beach, South Carolina, 29572
United States
Accurate Clinical Research
Baytown, Texas, 77521
United States
Pioneer Research Solutions, Inc
Cypress, Texas, 77429
United States
Accurate Clinical Research
Houston, Texas, 77089
United States
CardioVoyage
Sherman, Texas, 75090
United States
Center for Arthritis and Rheumatic Diseases, P.C.
Chesapeake, Virginia, 23320
United States
Arthritis and Osteoporosis Center of Northern Virginia
Manassas, Virginia, 20109
United States
Center for Arthritis and Rheumatic Diseases., P.C.
Suffolk, Virginia, 23435
United States
Arthritis Northwest, PLLC
Spokane, Washington, 99204
United States
Aurora Rheumatology and Immunotherapy Center
Franklin, Wisconsin, 53132
United States

Collaborators and Investigators

Sponsor: Sequenom, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2019-06-25
Study Completion Date2026-04-15

Study Record Updates

Study Start Date2019-06-25
Study Completion Date2026-04-15

Terms related to this study

Keywords Provided by Researchers

  • Rheumatoid Arthritis
  • Vectra
  • Radiographic Projections

Additional Relevant MeSH Terms

  • Rheumatoid Arthritis (RA)