Rheumatoid Arthritis
Conditions
Brief summary
Nine months multi-center prospective, randomized observational study, two arm trial to evaluate the effect of MBDA score-guided care on disease activity and medical costs.
Detailed description
Nine months multi-center prospective, randomized observational study, two arm trial to evaluate the effect of MBDA score-guided care on disease activity and medical costs. To investigate whether treatment decisions guided by MBDA scores result in reduced disease activity and overall medical cost among patients with RA relative to usual care (UC).
Interventions
GENETICVectra MBDA Test
Vectra Guided versus Usual Care
Sponsors
Laboratory Corporation of America
Sequenom, Inc.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Willing and able to sign an informed consent form (ICF) * Age at least 18 years old at screening visit * Diagnosed with RA according to 1987 or 2010 criteria of the American College of Rheumatology * Actively managed by a CareFirst health care practitioner * Currently taking one or more biologic and/or non-biologic DMARDs listed in Appendix 2 * Currently has CareFirst medical coverage
Exclusion criteria
* 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 * On non-biologic DMARD monotherapy or combination therapy with stable disease for ≥6 months * Any condition or circumstance that makes it likely the patient will not be able to complete the 9-month trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Mean MBDA Score | Baseline to 9 months | Change in disease activity from baseline to month 9 as measured by mean MBDA score. MBDA Score stands for the Vectra multi-biomarker disease activity (MBDA) blood test. Scale: Low (\>30); Moderate (30-44); High (\>44) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes in Overall Medical Costs | Baseline to 1 year | Changes in overall medical costs, RA-related medical costs, pharmacy costs, RA treatment medication costs, and biologic DMARD medication costs from baseline to one year, as defined in Appendix 2. |
| Medical Utilization | Baseline to 1 year | Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.). |
| Proportion of Patients who Showed a Response to Medication | Baseline to month 9 | Proportion of patients who showed a response to medication, defined as a decrease in MBDA score of at least 8 from baseline to month 9. |
| Pharmacy Utilization | Baseline to 1 year | Pharmacy utilization metrics (days' supply, prescriptions, etc.). |
| Treatment Adherence | Baseline to 1 year | Treatment adherence metrics measured according to medical possession ratio and time to discontinuation. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patients with Non-High MBDA Scores | Baseline to month 9 | Proportion of patients with non-high (≤44) MBDA scores from baseline to month 9. |
| Overall Medical Costs | Baseline to 1 year | Overall medical costs, pharmacy costs, RA treatment medication costs, and biologic DMARD medication costs (Appendix 2) from baseline to one year according to: 1. Baseline MBDA score category (low \<30, moderate 30-44, high \>44). 2. Whether treatment decisions were consistent with the MBDA score-based treatment guidance in Appendix 1 (guided treatment arm only). 3. Whether MBDA score category changed from baseline to month 9. 4. Whether biologic DMARD use was tapered. |
Countries
United States
Outcome results
None listed