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

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ClinicalTrials.gov Identifier: NCT03631225
Recruitment Status : Recruiting
First Posted : August 15, 2018
Last Update Posted : December 15, 2021
Sponsor:
Collaborator:
Laboratory Corporation of America
Information provided by (Responsible Party):
Sequenom, Inc.

Study Description
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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.

Condition or disease Intervention/treatment
Rheumatoid Arthritis (RA) Diagnostic Test: Vectra

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Study Design
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Study Type : Observational
Estimated Enrollment : 1500 participants
Observational Model: Cohort
Time Perspective: Prospective
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
Actual Study Start Date : June 25, 2019
Estimated Primary Completion Date : September 1, 2023
Estimated Study Completion Date : September 15, 2023

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Groups and Cohorts
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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


Outcome Measures
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Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.


Other Outcome Measures:
  1. 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.

  2. 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.

  3. 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)

  4. 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.

  5. 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.

  6. 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)

  7. 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)

  8. 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)

  9. 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)

  10. 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.


Biospecimen Retention:   Samples With DNA
Blood serum sample

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients diagnosed with active rheumatoid arthritis at pre-determined clinical sites
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03631225


Contacts
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Contact: Ana Gugila 647-501-3242 ana.gugila@labcorp.com
Contact: Graham McLennan 858-202-9162 mclenng@labcorp.com

Locations
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Sponsors and Collaborators
Sequenom, Inc.
Laboratory Corporation of America
Investigators
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Study Director: Elena Hitraya, MD Consultant
Principal Investigator: Jeffrey R. Curtis, MD, MPH University of Alabama at Birmingham
More Information
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Responsible Party: Sequenom, Inc.
ClinicalTrials.gov Identifier: NCT03631225    
Other Study ID Numbers: 133-CL-01
First Posted: August 15, 2018    Key Record Dates
Last Update Posted: December 15, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Sequenom, Inc.:
Rheumatoid Arthritis
Vectra
Radiographic Projections
Additional relevant MeSH terms:
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Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
 Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases