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

August 7, 2023 updated by: Sequenom, Inc.

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 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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Disease activity in RA can be assessed by physical examination, patient-reported outcomes (PROs) or laboratory tests. Joints counts and PROs are partly or entirely subjective. Their ability to support clinical assessment is limited in certain settings, including for RA patients with common comorbidities, such fibromyalgia, obesity, or depression, or with clinically uncertain inflammatory burden. It can be difficult to assess the origin of ongoing pain in such patients using clinical assessment alone. The two blood tests routinely used to assess RA disease activity, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), are objective but are in the normal range in more than half of RA patients with active disease, which reduces their negative predictive value and greatly limits their utility. These clinical and laboratory measures are variously combined in composite scores of RA disease activity, such as the 28-joint count Disease Activity Score (DAS28) or the Clinical Disease Activity Index (CDAI) which are not widely used in the US outside of clinical trials because complete, formal joint counts are time-consuming and composite scores pose logistic challenges in a busy clinic setting.

Radiographic progression (RP) is a validated endpoint accepted by the FDA for clinical trials that reflects RA-related damage to joints. It is associated with long-term disability. Optimal care requires that the risk of progression be reduced. Quantitative scoring of RP is performed only for clinical trials and is not used for assessing RP risk in clinical practice. Rheumatologists are generally not trained to score radiographs and they are very time-consuming to score, typically taking 20 or more minutes per patient for a skilled reader. However, they are a valuable scientific endpoint in that they serve as a valid proxy for long term damage and associated RA-related disability. Conventional clinical and laboratory-based measures of RA disease activity are weak predictors of RP, including among patients in clinical remission, where progression can still occur. Thus, an objective, convenient measure that reflects pathologically meaningful disease activity and predicts risk for progression is needed for optimal management of RA.

The multi-biomarker disease activity (MBDA) test, Vectra®, is an objective tool that combines serum concentrations of 12 biomarkers in a validated algorithm to produce a score on a scale of 1 to 100. The MBDA test was subsequently adjusted to account for the effects of age, sex, and leptin (a surrogate for adiposity) in patients with rheumatoid arthritis (RA). The Vectra score has been shown to be the strongest predictor of risk for RP, compared with conventional disease activity measures, including DAS28-CRP, CRP and the swollen joint count. In multivariate analyses, it was the only disease activity measure to independently predict RP. High Vectra scores (>44) are associated with greatest risk for progression and low and moderate scores with very low risk. Across multiple studies, Vectra has a negative predictive value for progression of 93-97%, and in a meta-analysis, the relative risk for progression with a high Vectra score (5.1) is substantially greater than with a high DAS28-CRP (1.4) or high CRP (1.6). The predictive value of Vectra exists even when the Vectra score and clinical measures are discordant, which means that patients with high DAS28-CRP have little risk for RP when Vectra score is low and, conversely, patients with low DAS28-CRP have high risk for RP when Vectra score is high.

Thus, reducing high Vectra scores should be a primary goal of therapy, regardless of the level of clinical disease activity, and using Vectra scores to guide therapy should be an effective way to prevent radiographic progression. A recent prospective study of daily and diurnal variation in Vectra score established that the minimally important difference (MID) in Vectra score - i.e., the magnitude of change in Vectra score that is needed to be confident that it reflects real biologic change and is not due only to random variation - is greater than or equal to 8 Vectra units. Accordingly, a threshold of 8 can be used in guidances for using Vectra to evaluate treatment response.

The primary objective is to compare the clinical response from baseline to 12 months among patients with RA receiving Vectra-Guided care versus those receiving usual care.

The secondary objectives of this study are to:

  • Evaluate the rate of radiographic progression from baseline to year 1 among patients with RA whose care is guided by Vectra relative to those receiving usual care.
  • Evaluate changes in Vectra score from baseline to 6 months and baseline to year 1 among patients with RA whose care is guided by Vectra DA relative to those receiving usual care.
  • Evaluate clinical response from baseline to 1 year among patients with RA receiving Vectra-guided care relative to those receiving usual care.

Study Type

Observational

Enrollment (Estimated)

1500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • California
      • La Mesa, California, United States, 91942
        • Recruiting
        • Bio Solutions Clinical Research
        • Contact:
        • Principal Investigator:
          • Thomas Adamson, MD
      • Murrieta, California, United States, 92563
      • Orange, California, United States, 92868
        • Recruiting
        • J. Lee MD Medical Corp
        • Contact:
        • Principal Investigator:
          • Joo- Hyung Lee, MD
    • Delaware
      • Lewes, Delaware, United States, 19958
        • Recruiting
        • Delaware Arthritis
        • Contact:
        • Principal Investigator:
          • Jose Pando, M.D.
    • Florida
      • Aventura, Florida, United States, 33180
        • Recruiting
        • AARDS Research, Inc.
        • Contact:
        • Principal Investigator:
          • Norman B. Gaylis, MD
      • Clearwater, Florida, United States, 33765
        • Recruiting
        • Robert W. Levin, MD, PA
        • Contact:
        • Principal Investigator:
          • Robert W. Levin, M.D.
      • Miami, Florida, United States, 33133
        • Recruiting
        • Artemisa Analytics
        • Contact:
        • Principal Investigator:
          • Carlos Alonso, MD
      • Orlando, Florida, United States, 32806
        • Recruiting
        • Rheumatology Associates of Central Florida, P.A.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Pamela G. Freeman, MD
      • South Miami, Florida, United States, 33141
        • Recruiting
        • Clin-Med Research & Development, LLC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Jaime Pachon, MD
    • Louisiana
      • Lake Charles, Louisiana, United States, 70605
      • Monroe, Louisiana, United States, 71203
    • Mississippi
      • Tupelo, Mississippi, United States, 38801
        • Recruiting
        • North Mississippi Medical Center
        • Contact:
        • Principal Investigator:
          • Charles King, MD
    • Missouri
      • Springfield, Missouri, United States, 65810
        • Recruiting
        • Clinvest Research, LLC.
        • Contact:
        • Contact:
        • Principal Investigator:
          • David G. True, D.O.
    • New York
      • Smithtown, New York, United States, 11787
        • Recruiting
        • Rheumatology Associates of Long Island
        • Contact:
        • Principal Investigator:
          • Hong Xu, MD
    • Ohio
      • Middleburg Heights, Ohio, United States, 44130
        • Recruiting
        • Paramount Medical Research & Consulting, LLC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Isam Diab, MD
        • Sub-Investigator:
          • Cynthia Gendics, MD
      • Wheelersburg, Ohio, United States, 45694
        • Recruiting
        • Southern Ohio Rheumatology Inc.
        • Contact:
        • Principal Investigator:
          • Rajesh Kataria, D.O.
    • Pennsylvania
      • Bethlehem, Pennsylvania, United States, 18015
      • Duncansville, Pennsylvania, United States, 16635
        • Recruiting
        • Altoona Center for Clinical Research
        • Principal Investigator:
          • Alan Kivitz, MD
        • Contact:
      • Wexford, Pennsylvania, United States, 15090
        • Recruiting
        • Advanced Rheumatology & Arthritis Research Center, PC
        • Contact:
        • Principal Investigator:
          • Angela Stupi, MD
      • Wyomissing, Pennsylvania, United States, 19610
        • Recruiting
        • PA Regional Center for Arthritis and Osteoporosis Research
        • Contact:
        • Principal Investigator:
          • Gregory R. Emkey, MD
    • South Carolina
      • Myrtle Beach, South Carolina, United States, 29572
        • Recruiting
        • Carolina Health Specialists
        • Contact:
        • Principal Investigator:
          • David Lazar, MD
    • Texas
      • Baytown, Texas, United States, 77521
      • Cypress, Texas, United States, 77429
        • Recruiting
        • Pioneer Research Solutions, Inc
        • Contact:
        • Principal Investigator:
          • Asif Cochinwala, MD
      • Houston, Texas, United States, 77089
      • Sherman, Texas, United States, 75090
    • Virginia
      • Chesapeake, Virginia, United States, 23320
        • Recruiting
        • Center for Arthritis and Rheumatic Diseases, P.C.
        • Contact:
        • Contact:
        • Principal Investigator:
          • Roger W. Lidman, M.D.
        • Sub-Investigator:
          • Witold A. Turkiewicz, M.D.
        • Sub-Investigator:
          • Julianne S. Orlowski, D.O.
        • Sub-Investigator:
          • John V. Mansoor, M.D.
        • Sub-Investigator:
          • Megan E. Eshbaugh, D.O.
      • Manassas, Virginia, United States, 20109
        • Recruiting
        • Arthritis and Osteoporosis Center of Northern Virginia
        • Contact:
        • Contact:
        • Principal Investigator:
          • Mohsen Ghafouri, M.D.
        • Sub-Investigator:
          • Audry Rubana, N.P.
        • Sub-Investigator:
          • Parita Vasa, M.D.
      • Suffolk, Virginia, United States, 23435
        • Recruiting
        • Center for Arthritis and Rheumatic Diseases., P.C.
        • Principal Investigator:
          • Roger W. Lidman, M.D.
        • Sub-Investigator:
          • Witold A. Turkiewicz, M.D.
        • Sub-Investigator:
          • Julianne S. Orlowski, D.O.
        • Sub-Investigator:
          • John V. Mansoor, M.D.
        • Sub-Investigator:
          • Megan E. Eshbaugh, D.O.
        • Contact:
        • Contact:
    • Washington
      • Spokane, Washington, United States, 99204
        • Recruiting
        • Arthritis Northwest, PLLC
        • Contact:
        • Contact:
        • Principal Investigator:
          • Christopher Wright, M.D.
        • Sub-Investigator:
          • Howard Kenney, M.D.
        • Sub-Investigator:
          • Sean LaSalle, M.D.
        • Sub-Investigator:
          • Jeffrey Butler, M.D.
        • Sub-Investigator:
          • Eric Mueller, M.D.
        • Sub-Investigator:
          • Gary Craig, M.D.
        • Sub-Investigator:
          • Michael Coan, M.D.
    • Wisconsin
      • Franklin, Wisconsin, United States, 53132
        • Recruiting
        • Aurora Rheumatology and Immunotherapy Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Alvin Wells, MD

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients diagnosed with active rheumatoid arthritis at pre-determined clinical sites

Description

Inclusion 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

Exclusion Criteria:

  • 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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Guided-Care Arm
Physicians will use the reported Vectra score to guide treatment decisions
Diagnostic test: 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)
Usual Care Arm
Physicians will treat patient per standard of care without the use of the Vectra score

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
ACR20 response at 12 months
Time Frame: Baseline visit to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Radiographic progression at 1 year
Time Frame: Baseline to 12 months (1 year)
A secondary endpoint of this study is the rate of radiographic progression at 1 year, as measured by the change (Δ) in modified total Sharp score (mTSS) from baseline to 1 year.
Baseline to 12 months (1 year)
Change in Vectra score
Time Frame: Baseline to 6 months, and baseline and 12 months (1 year)
Another secondary endpoint of this study is the change in Vectra score.
Baseline to 6 months, and baseline and 12 months (1 year)
ACR20 response at 6 months
Time Frame: Baseline to 12 months (1 year)
Another secondary 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 12 months (1 year) that accounts for differences in baseline risk factors between the two arms and intracluster correlation induced by site cluster randomization.
Baseline to 12 months (1 year)

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Exploring a change in the definition of non-progression less than or equal to 5
Time Frame: Baseline to 12 months (1 year)
The percentage of patients with radiographic non-progression, defined as ΔmTSS less than or equal to 5 from baseline to 1 year.
Baseline to 12 months (1 year)
Exploring a change in the definition of non-progression less than or equal to 3
Time Frame: Baseline to 12 months (1 year)
The percentage of patients with radiographic non-progression, defined as ΔmTSS less than or equal to 3 from baseline to 1 year.
Baseline to 12 months (1 year)
Change in physical function measured by HAQ-D1
Time Frame: Baseline to 12 months (1 year)
Change in physical function measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)
Baseline to 12 months (1 year)
Change in clinical disease activity measured by Patient Reported Outcomes Measurement Information System (PROMIS)
Time Frame: Baseline to 12 months (1 year)
Change in clinical disease activity measured by PROMIS (Fatigue, Pain Interference, and Social Participation).PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions.
Baseline to 12 months (1 year)
Change in physical function measured by PROMIS
Time Frame: Baseline to 12 months (1 year)
Change in physical function measured by the Patient Reported Outcomes Measurement Information System (PROMIS) physical function 10 (PF10). PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions.
Baseline to 12 months (1 year)
Change in clinical disease activity measured by RAPID3
Time Frame: Baseline to 12 months (1 year)
Change in clinical disease activity measured by Routine Assessment of Patient Index Data 3 (RAPID3)
Baseline to 12 months (1 year)
Change in clinical disease activity measured by CDAI
Time Frame: Baseline to 12 months (1 year)
Change in clinical disease activity measured by the Clinical Disease Activity Index (CDAI)
Baseline to 12 months (1 year)
Change in clinical disease activity measured by SDAI
Time Frame: Baseline to 12 months (1 year)
Change in clinical disease activity measured by the Simplified Disease Activity Index (SDAI)
Baseline to 12 months (1 year)
Change in clinical disease activity measured by DAS28-CRP
Time Frame: Baseline to 12 months (1 year)
Change in clinical disease activity measured by the Disease Activity Score 28-joint count C reactive protein (DAS28-CRP)
Baseline to 12 months (1 year)
The frequency of changes in RA medications [non-biologic, biologic, or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs)]
Time Frame: Baseline to 12 months (1 year)
Defined as the number of changes per subject per year in type or dosage of prescribed RA medication during the study period.
Baseline to 12 months (1 year)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sequenom, Inc.

Collaborators

Laboratory Corporation of America

Investigators

  • Study Director: Elena Hitraya, MD, Consultant
  • Principal Investigator: Jeffrey R. Curtis, MD, MPH, University of Alabama at Birmingham

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 Major Dates

Study Start (Actual)

June 25, 2019

Primary Completion (Estimated)

September 1, 2025

Study Completion (Estimated)

September 15, 2025

Study Registration Dates

First Submitted

August 3, 2018

First Submitted That Met QC Criteria

August 10, 2018

First Posted (Actual)

August 15, 2018

Study Record Updates

Last Update Posted (Actual)

August 9, 2023

Last Update Submitted That Met QC Criteria

August 7, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 133-CL-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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