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| Name | Class |
|---|---|
| Laboratory Corporation of America | INDUSTRY |
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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.
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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vectra Guided | For patients in the guided care arm, treating physicians will receive the Vectra MBDA Test score prior to the patient visit and will have a set of guidance for decision-making based on these scores. Treating physicians will be strongly encouraged to follow the guidance but will not be required to do so. For test results to be available at the time of each visit in the MBDA guided treatment arm, blood testing will be performed 7-10 days before the visit. |
| |
| Usual Care | For patients in the UC arm, treating physicians will not have access to MBDA scores until the end of the study. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vectra MBDA Test | Genetic | Vectra Guided versus Usual Care |
|
| Measure | Description | Time Frame |
|---|---|---|
| Mean MBDA Score | 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) | Baseline to 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Overall Medical Costs | 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. | Baseline to 1 year |
| Medical Utilization |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of Patients with Non-High MBDA Scores | Proportion of patients with non-high (≤44) MBDA scores from baseline to month 9. | Baseline to month 9 |
| Overall Medical Costs | Overall medical costs, pharmacy costs, RA treatment medication costs, and biologic DMARD medication costs (Appendix 2) from baseline to one year according to:
|
Inclusion Criteria:
Exclusion Criteria:
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Adults with RA who are currently taking one or more non-biologic DMARD and/or biologic DMARD listed in Appendix 2.
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| Name | Affiliation | Role |
|---|---|---|
| Elena Hitraya, MD | Consultant | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Annapolis Rheumatology LLC | Annapolis | Maryland | 21401 | United States | ||
| Lifebridge Sinai Hospital of Baltimore |
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Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.). |
| Baseline to 1 year |
| Proportion of Patients who Showed a Response to Medication | 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. | Baseline to month 9 |
| Pharmacy Utilization | Pharmacy utilization metrics (days' supply, prescriptions, etc.). | Baseline to 1 year |
| Treatment Adherence | Treatment adherence metrics measured according to medical possession ratio and time to discontinuation. | Baseline to 1 year |
| Baseline to 1 year |
| Baltimore |
| Maryland |
| 21215 |
| United States |
| Rheumatology Associates of Baltimore LLC | Baltimore | Maryland | 21286 | United States |
| Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC. | Catonsville | Maryland | 21228 | United States |
| Arthritis Care Specialists of Maryland | Columbia | Maryland | 21046 | United States |
| Klein & Associates | Cumberland | Maryland | 21502 | United States |
| Mid-Atlantic Rheumatology | Glen Burnie | Maryland | 21060 | United States |
| Arthritis & Pain Associates of PG County | Greenbelt | Maryland | 20770 | United States |
| Klein & Associates | Hagerstown | Maryland | 21502 | United States |
| MedStar Shah Medical Group | Hollywood | Maryland | 20639 | United States |
| The Center for Rheumatology and Bone Research | Wheaton | Maryland | 20902 | United States |
| ID | Term |
|---|---|
| D001172 | Arthritis, Rheumatoid |
| ID | Term |
|---|---|
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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