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

Recruiting at 29 trial locations

Overseen By Graham McLennan

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Myriad Genetic Laboratories, Inc.

Must be taking: Dmards

Must not be taking: Anti-il-6r drugs

Disqualifiers: Active infection, Recent malignancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

1500 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

Jeffrey R. Curtis, MD, MPH

Principal Investigator

University of Alabama at Birmingham

Elena Hitraya, MD

Principal Investigator

Consultant

Are You a Good Fit for This Trial?

Inclusion Criteria

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either Vectra-guided care or usual care for rheumatoid arthritis

12 months

Regular visits as per study protocol

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Vectra DA

How Is the Trial Designed?

Group I: Usual Care Arm Experimental Treatment 0 Interventions

Physicians will treat patient per standard of care without the use of the Vectra score

Group II: Guided-Care Arm Experimental Treatment 1 Intervention

Physicians will use the reported Vectra score to guide treatment decisions

Who Is Running the Clinical Trial?

Myriad Genetic Laboratories, Inc.

Lead Sponsor

Trials

32

Recruited

14,600+

Sequenom, Inc.

Lead Sponsor

Trials

27

Recruited

64,700+

Laboratory Corporation of America

Industry Sponsor

Trials

32

Recruited

18,800+