Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test

Rheumatoid Arthritis Clinical Trial

— CareFirst  

Official title:

Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test on Clinical Outcomes and Pharmaceutical Utilization in Patients With Rheumatoid Arthritis: A Prospective, Randomized Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03810144
• Other study ID #: 128-CL-01
• Status: Completed
• Start date: October 22, 2018
• Est. completion date: October 16, 2022

Study information

• Verified date: August 2023
• Source: Sequenom, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 444
• Est. completion date: October 16, 2022
• Est. primary completion date: August 16, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Rheumatoid Arthritis

Intervention

Genetic:
• Vectra MBDA Test
Vectra Guided versus Usual Care

Locations

Country	Name	City	State
United States	Annapolis Rheumatology LLC	Annapolis	Maryland
United States	Lifebridge Sinai Hospital of Baltimore	Baltimore	Maryland
United States	Rheumatology Associates of Baltimore LLC	Baltimore	Maryland
United States	Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC.	Catonsville	Maryland
United States	Arthritis Care Specialists of Maryland	Columbia	Maryland
United States	Klein & Associates	Cumberland	Maryland
United States	Mid-Atlantic Rheumatology	Glen Burnie	Maryland
United States	Arthritis & Pain Associates of PG County	Greenbelt	Maryland
United States	Klein & Associates	Hagerstown	Maryland
United States	MedStar Shah Medical Group	Hollywood	Maryland
United States	The Center for Rheumatology and Bone Research	Wheaton	Maryland

Sponsors (2)

Lead Sponsor	Collaborator
Sequenom, Inc.	Laboratory Corporation of America

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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: 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.	Baseline to 1 year
Primary	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
Secondary	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
Secondary	Medical Utilization	Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.).	Baseline to 1 year
Secondary	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
Secondary	Pharmacy Utilization	Pharmacy utilization metrics (days' supply, prescriptions, etc.).	Baseline to 1 year
Secondary	Treatment Adherence	Treatment adherence metrics measured according to medical possession ratio and time to discontinuation.	Baseline to 1 year