Clinical trial NCT03810144: Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Lead sponsor: Sequenom, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Laboratory Corporation of America
First posted: 2019-01-18
Enrollment: 444
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with RA who are currently taking one or more non-biologic DMARD and/or biologic DMARD listed in Appendix 2.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Mean MBDA Score
timeFrame: Baseline to 9 months
Secondary outcomes:
measure: Changes in Overall Medical Costs
timeFrame: Baseline to 1 year
measure: Medical Utilization
timeFrame: Baseline to 1 year
measure: Proportion of Patients who Showed a Response to Medication
timeFrame: Baseline to month 9
measure: Pharmacy Utilization
timeFrame: Baseline to 1 year
measure: Treatment Adherence
timeFrame: Baseline to 1 year
Other outcomes:
measure: Proportion of Patients with Non-High MBDA Scores
timeFrame: Baseline to month 9
measure: Overall Medical Costs
timeFrame: Baseline to 1 year
Locations:
city: Annapolis
country: United States
facility: Annapolis Rheumatology LLC
state: Maryland
city: Baltimore
country: United States
facility: Lifebridge Sinai Hospital of Baltimore
state: Maryland
city: Baltimore
country: United States
facility: Rheumatology Associates of Baltimore LLC
state: Maryland
city: Catonsville
country: United States
facility: Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC.
state: Maryland
city: Columbia
country: United States
facility: Arthritis Care Specialists of Maryland
state: Maryland
city: Cumberland
country: United States
facility: Klein & Associates
state: Maryland
city: Glen Burnie
country: United States
facility: Mid-Atlantic Rheumatology
state: Maryland
city: Greenbelt
country: United States
facility: Arthritis & Pain Associates of PG County
state: Maryland
city: Hagerstown
country: United States
facility: Klein & Associates
state: Maryland
city: Hollywood
country: United States
facility: MedStar Shah Medical Group
state: Maryland
city: Wheaton
country: United States
facility: The Center for Rheumatology and Bone Research
state: Maryland
Study officials:
affiliation: Consultant
name: Elena Hitraya, MD
role: STUDY_DIRECTOR
References: