Impact of Guided Care With the Vectra DA Multi-biomarker Disease Activity (MBDA) Blood Test (CareFirst)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03810144|
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
|Condition or disease||Intervention/treatment||Phase|
|Rheumatoid Arthritis||Genetic: Vectra DA MBDA Test||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||440 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Impact of Guided Care With the Vectra DA Multi-biomarker Disease Activity (MBDA) Blood Test on Clinical Outcomes and Pharmaceutical Utilization in Patients With Rheumatoid Arthritis: A Prospective, Randomized Study|
|Actual Study Start Date :||October 22, 2018|
|Estimated Primary Completion Date :||December 2019|
|Estimated Study Completion Date :||December 2019|
Experimental: Vectra Guided
For patients in the guided care arm, treating physicians will receive the Vectra DA 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 1 week before the visit.
Genetic: Vectra DA MBDA Test
Vectra Guided versus Usual Care
No Intervention: Usual Care
For patients in the UC arm, treating physicians will not have access to MBDA scores until the end of the study.
- Mean MBDA Score [ Time Frame: 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 DA multi-biomarker disease activity (MBDA) blood test.
Scale: Low (>30); Moderate (30-44); High (>44)
- Changes in Overall Medical Costs [ Time Frame: 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 [ Time Frame: Baseline to 1 year ]Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.).
- Proportion of Patients who Showed a Response to Medication [ Time Frame: 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 [ Time Frame: Baseline to 1 year ]Pharmacy utilization metrics (days' supply, prescriptions, etc.).
- Treatment Adherence [ Time Frame: Baseline to 1 year ]Treatment adherence metrics measured according to medical possession ratio and time to discontinuation.
- Proportion of Patients with Non-High MBDA Scores [ Time Frame: Baseline to month 9 ]Proportion of patients with non-high (≤44) MBDA scores from baseline to month 9.
- Overall Medical Costs [ Time Frame: 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:
- Baseline MBDA score category (low <30, moderate 30-44, high >44).
- Whether treatment decisions were consistent with the MBDA score-based treatment guidance in Appendix 1 (guided treatment arm only).
- Whether MBDA score category changed from baseline to month 9.
- Whether biologic DMARD use was tapered.
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): NCT03810144
|Contact: Stacy Meluskeyemail@example.com|
|United States, Maryland|
|Arthritis Care Specialists of Maryland||Recruiting|
|Columbia, Maryland, United States, 21046|
|Contact: Robyn Bell, CCMA 410-992-7440 firstname.lastname@example.org|
|Principal Investigator: Thomas Lang, MD|
|Klein & Associates||Recruiting|
|Hagerstown, Maryland, United States, 21502|
|Contact: Christina Chyr, BA 301-791-6680 ext 1144 email@example.com|
|Principal Investigator: Mary Howell, MD|
|Sub-Investigator: Steven Klein, MD|
|The Center for Rheumatology and Bone Research||Recruiting|
|Wheaton, Maryland, United States, 20902|
|Contact: Ashling Bauer, BA 301-942-6610 firstname.lastname@example.org|
|Principal Investigator: Alan K Matsumoto, MD|
|Sub-Investigator: Herbert SB Baraf, MD, FACP|
|Sub-Investigator: Robert L Rosenberg, MD, FACR|
|Sub-Investigator: Evan L Siegel, MD, FACR|
|Sub-Investigator: Nicole S Thomas, MD, FACR|
|Sub-Investigator: Grace E Ahn, MD, FACR|
|Sub-Investigator: Jeffrey A Potter, MD, FACR|
|Sub-Investigator: Grant H Louie, MD|