Evaluating Vectra for guiding treatment in 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
Sequenom, Inc. · NCT03631225
This study is testing if the Vectra blood test can help doctors make better treatment decisions for people with rheumatoid arthritis compared to regular care.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Sequenom, Inc. (industry) |
| Drugs / interventions | tocilizumab, sarilumab |
| Locations | 30 sites (La Mesa, California and 29 other locations) |
| Trial ID | NCT03631225 on ClinicalTrials.gov |
What this trial studies
This study aims to assess the effectiveness of the Vectra blood test in guiding treatment decisions for patients with rheumatoid arthritis (RA) compared to standard care. Vectra analyzes 12 biomarkers to produce a score that predicts disease progression, which may help in optimizing treatment strategies. The study will involve patients who are already receiving treatment for RA and will evaluate the clinical benefits of using Vectra in a real-world setting. By comparing outcomes between those guided by Vectra and those receiving usual care, the study seeks to provide insights into improving RA management.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older diagnosed with rheumatoid arthritis who have a CDAI score greater than 10 and are currently on DMARD therapy.
Not a fit: Patients currently taking anti-IL-6R drugs or those with contraindications to new RA therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to better treatment outcomes and reduced joint damage for patients with rheumatoid arthritis.
How similar studies have performed: While the use of biomarkers in RA management is established, the specific application of Vectra in this context is being evaluated for the first time in a real-world setting.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Mesa, California and 29 other locations
- Bio Solutions Clinical Research — La Mesa, California, United States (RECRUITING)
- Brigid Freyne, MD — Murrieta, California, United States (RECRUITING)
- J. Lee MD Medical Corp — Orange, California, United States (RECRUITING)
- Delaware Arthritis — Lewes, Delaware, United States (RECRUITING)
- AARDS Research, Inc. — Aventura, Florida, United States (RECRUITING)
- Robert W. Levin, MD, PA — Clearwater, Florida, United States (RECRUITING)
- Artemisa Analytics — Miami, Florida, United States (RECRUITING)
- Rheumatology Associates of Central Florida, P.A. — Orlando, Florida, United States (RECRUITING)
- Clin-Med Research & Development, LLC — South Miami, Florida, United States (RECRUITING)
- Accurate Clinical Research — Lake Charles, Louisiana, United States (RECRUITING)
- Arthritis and Diabetes Clinic, Inc. — Monroe, Louisiana, United States (RECRUITING)
- North Mississippi Medical Center — Tupelo, Mississippi, United States (RECRUITING)
- Clinvest Research, LLC. — Springfield, Missouri, United States (RECRUITING)
- Rheumatology Associates of Long Island — Smithtown, New York, United States (RECRUITING)
- Paramount Medical Research & Consulting, LLC — Middleburg Heights, Ohio, United States (RECRUITING)
- Southern Ohio Rheumatology Inc. — Wheelersburg, Ohio, United States (RECRUITING)
- East Penn Rheumatology Associates, P.C. — Bethlehem, Pennsylvania, United States (RECRUITING)
- Altoona Center for Clinical Research — Duncansville, Pennsylvania, United States (RECRUITING)
- Advanced Rheumatology & Arthritis Research Center, PC — Wexford, Pennsylvania, United States (RECRUITING)
- PA Regional Center for Arthritis and Osteoporosis Research — Wyomissing, Pennsylvania, United States (RECRUITING)
- Carolina Health Specialists — Myrtle Beach, South Carolina, United States (RECRUITING)
- Accurate Clinical Research — Baytown, Texas, United States (RECRUITING)
- Pioneer Research Solutions, Inc — Cypress, Texas, United States (RECRUITING)
- Accurate Clinical Research — Houston, Texas, United States (RECRUITING)
- CardioVoyage — Sherman, Texas, United States (RECRUITING)
- Center for Arthritis and Rheumatic Diseases, P.C. — Chesapeake, Virginia, United States (RECRUITING)
- Arthritis and Osteoporosis Center of Northern Virginia — Manassas, Virginia, United States (RECRUITING)
- Center for Arthritis and Rheumatic Diseases., P.C. — Suffolk, Virginia, United States (RECRUITING)
- Arthritis Northwest, PLLC — Spokane, Washington, United States (RECRUITING)
- Aurora Rheumatology and Immunotherapy Center — Franklin, Wisconsin, United States (RECRUITING)
Study contacts
- Principal investigator: Jeffrey R. Curtis, MD, MPH — University of Alabama at Birmingham
- Study coordinator: Ana Gugila
- Email: ana.gugila@labcorp.com
- Phone: 647-501-3242
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Rheumatoid Arthritis, Vectra, Radiographic Projections