Rheumatoid ArthritisCareFirstNCT03810144
Impact of Guided Care With the Vectra Multi-biomarker Disease Activity (MBDA) Blood Test
An observational study of Rheumatoid Arthritis, run by Sequenom, Inc. at 11 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Vectra MBDA Test
- How many people
- 444 participants
- Where
- 11 sitesUnited States
- Study dates
- 22 Oct 2018to 16 Oct 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with RA who are currently taking one or more non-biologic DMARD and/or biologic DMARD listed in Appendix 2.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
United States11 sites
Annapolis Rheumatology LLC
Annapolis, Maryland, 21401
Lifebridge Sinai Hospital of Baltimore
Baltimore, Maryland, 21215
Rheumatology Associates of Baltimore LLC
Baltimore, Maryland, 21286
Nasseri Clinic of Arthritis & Rheumatic Diseases, LLC.
Catonsville, Maryland, 21228
Arthritis Care Specialists of Maryland
Columbia, Maryland, 21046
Klein & Associates
Cumberland, Maryland, 21502
Mid-Atlantic Rheumatology
Glen Burnie, Maryland, 21060
Arthritis & Pain Associates of PG County
Greenbelt, Maryland, 20770
Klein & Associates
Hagerstown, Maryland, 21502
MedStar Shah Medical Group
Hollywood, Maryland, 20639
The Center for Rheumatology and Bone Research
Wheaton, Maryland, 20902
About this study
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
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.
Read the 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).
- Conditions
- Rheumatoid Arthritis
- Being tested
- Vectra MBDA Test
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vectra MBDA TestGenetic
Vectra Guided versus Usual Care
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Genetic: Vectra MBDA Test | |
| Usual Care | For patients in the UC arm, treating physicians will not have access to MBDA scores until the end of the study. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: Baseline to 9 months
Secondary outcomes (5)
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.
Measured: Baseline to 1 year
Medical Utilization
Medical utilization metrics (admissions, readmissions, emergency room visits, physician visits, etc.).
Measured: 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.
Measured: Baseline to month 9
Pharmacy Utilization
Pharmacy utilization metrics (days' supply, prescriptions, etc.).
Measured: Baseline to 1 year
Treatment Adherence
Treatment adherence metrics measured according to medical possession ratio and time to discontinuation.
Measured: Baseline to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start22 Oct 2018
- Primary completion16 Aug 2022
- Study completion16 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 444 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sequenom, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Laboratory Corporation of America
- Responsible party
- Sponsor
- Investigators
- Elena Hitraya, MD, Study director, Consultant
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03810144
- Sponsor's protocol ID
- 128-CL-01
- Acronym
- CareFirst
- Status last verified
- Aug 2023
- First submitted
- 26 Dec 2018
- Last updated
- 9 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03810144
- Acronym / sponsor ID
- CareFirst / 128-CL-01
- Conditions
- Rheumatoid Arthritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 444 participants (actual)
- Lead sponsor
- Sequenom, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Laboratory Corporation of America
- Study start
- 22 Oct 2018 (actual)
- Primary completion
- 16 Aug 2022 (actual)
- Study completion
- 16 Oct 2022 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vectra Guided | – | Genetic: Vectra MBDA TestFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with RA who are currently taking one or more non-biologic DMARD and/or biologic DMARD listed in Appendix 2.
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vectra MBDA TestVectra Guided versus Usual Care | Genetic | Vectra Guided |
Primary outcome
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 multi-biomarker disease activity (MBDA) blood test. Scale: Low (>30); Moderate (30-44); High (>44)
5 secondary outcomes
Changes in Overall Medical Costs
Time frame: Baseline to 1 year
Medical Utilization
Time frame: Baseline to 1 year
Proportion of Patients who Showed a Response to Medication
Time frame: Baseline to month 9
Pharmacy Utilization
Time frame: Baseline to 1 year
Treatment Adherence
Time frame: Baseline to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Elena Hitraya, MD study director
Consultant
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rheumatoid Arthritis, run by Sequenom, Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean MBDA Score (time frame: Baseline to 9 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Aug 2023.