The Effect of Guided Care With Vectra Compared to Treatment as Usual in Patients With Rheumatoid Arthritis
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
1 other identifier
observational
1,500
1 country
30
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jun 2019
Longer than P75 for all trials
30 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 3, 2018
CompletedFirst Posted
Study publicly available on registry
August 15, 2018
CompletedStudy Start
First participant enrolled
June 25, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2026
CompletedStudy Completion
Last participant's last visit for all outcomes
April 15, 2026
CompletedNovember 6, 2025
November 1, 2025
6.6 years
August 3, 2018
November 4, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
ACR20 response at 12 months
The primary endpoint of this study is ACR20 response, as compared between the guided-care arm and the usual care arm using a generalized estimating equation for logistic regression at six months that accounts for differences in baseline risk factors between the two arms and intracluster correlation induced by site cluster randomization.
Baseline visit to 12 months
Secondary Outcomes (3)
Radiographic progression at 1 year
Baseline to 12 months (1 year)
Change in Vectra score
Baseline to 6 months, and baseline and 12 months (1 year)
ACR20 response at 6 months
Baseline to 12 months (1 year)
Other Outcomes (10)
Exploring a change in the definition of non-progression less than or equal to 5
Baseline to 12 months (1 year)
Exploring a change in the definition of non-progression less than or equal to 3
Baseline to 12 months (1 year)
Change in physical function measured by HAQ-D1
Baseline to 12 months (1 year)
- +7 more other outcomes
Study Arms (2)
Guided-Care Arm
Physicians will use the reported Vectra score to guide treatment decisions
Usual Care Arm
Physicians will treat patient per standard of care without the use of the Vectra score
Interventions
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)
Eligibility Criteria
Patients diagnosed with active rheumatoid arthritis at pre-determined clinical sites
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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Sequenom, Inc.lead
- Laboratory Corporation of Americacollaborator
Study Sites (30)
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
Biospecimen
Blood serum sample
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 3, 2018
First Posted
August 15, 2018
Study Start
June 25, 2019
Primary Completion
February 1, 2026
Study Completion
April 15, 2026
Last Updated
November 6, 2025
Record last verified: 2025-11
Data Sharing
- IPD Sharing
- Will not share