An observational study in Rheumatoid Arthritis (RA), sponsored by Sequenom, Inc.. Completed at 30 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-21.
Sponsored by Sequenom, Inc. (part of Labcorp) · Observational
The goal of treating patients diagnosed with rheumatoid arthritis (RA) is to achieve remission or low disease activity and thereby prevent joint damage, loss of physical function, and disability. Optimal management requires regular assessment of disease activity, with treatment changes made as needed for optimal efficacy. Vectra is a blood serum test that looks at 12 biomarkers and produces a score on a scale of 1 to 100. The Vectra score has been shown to be the strongest predictor of risk for progression of disease. There is opportunity to gain more information about the utility of Vectra in a real-world clinical setting. This study will, therefore, evaluate the utility of Vectra for guiding treatment decisions and improving RA-related outcomes in comparison with usual care, which will not include Vectra testing. This study will enable a direct evaluation of the clinical benefit associated with using Vectra to guide treatment decisions in patients with RA.
Disease activity in RA can be assessed by physical examination, patient-reported outcomes (PROs) or laboratory tests. Joints counts and PROs are partly or entirely subjective. Their ability to support clinical assessment is limited in certain settings, including for RA patients with common comorbidities, such fibromyalgia, obesity, or depression, or with clinically uncertain inflammatory burden. It can be difficult to assess the origin of ongoing pain in such patients using clinical assessment alone. The two blood tests routinely used to assess RA disease activity, erythrocyte sedimentation rate (ESR) and C-reactive protein (CRP), are objective but are in the normal range in more than half of RA patients with active disease, which reduces their negative predictive value and greatly limits their utility. These clinical and laboratory measures are variously combined in composite scores of RA disease activity, such as the 28-joint count Disease Activity Score (DAS28) or the Clinical Disease Activity Index (CDAI) which are not widely used in the US outside of clinical trials because complete, formal joint counts are time-consuming and composite scores pose logistic challenges in a busy clinic setting.
Radiographic progression (RP) is a validated endpoint accepted by the FDA for clinical trials that reflects RA-related damage to joints. It is associated with long-term disability. Optimal care requires that the risk of progression be reduced. Quantitative scoring of RP is performed only for clinical trials and is not used for assessing RP risk in clinical practice. Rheumatologists are generally not trained to score radiographs and they are very time-consuming to score, typically taking 20 or more minutes per patient for a skilled reader. However, they are a valuable scientific endpoint in that they serve as a valid proxy for long term damage and associated RA-related disability. Conventional clinical and laboratory-based measures of RA disease activity are weak predictors of RP, including among patients in clinical remission, where progression can still occur. Thus, an objective, convenient measure that reflects pathologically meaningful disease activity and predicts risk for progression is needed for optimal management of RA.
The multi-biomarker disease activity (MBDA) test, Vectra®, is an objective tool that combines serum concentrations of 12 biomarkers in a validated algorithm to produce a score on a scale of 1 to 100. The MBDA test was subsequently adjusted to account for the effects of age, sex, and leptin (a surrogate for adiposity) in patients with rheumatoid arthritis (RA). The Vectra score has been shown to be the strongest predictor of risk for RP, compared with conventional disease activity measures, including DAS28-CRP, CRP and the swollen joint count. In multivariate analyses, it was the only disease activity measure to independently predict RP. High Vectra scores (>44) are associated with greatest risk for progression and low and moderate scores with very low risk. Across multiple studies, Vectra has a negative predictive value for progression of 93-97%, and in a meta-analysis, the relative risk for progression with a high Vectra score (5.1) is substantially greater than with a high DAS28-CRP (1.4) or high CRP (1.6). The predictive value of Vectra exists even when the Vectra score and clinical measures are discordant, which means that patients with high DAS28-CRP have little risk for RP when Vectra score is low and, conversely, patients with low DAS28-CRP have high risk for RP when Vectra score is high.
Thus, reducing high Vectra scores should be a primary goal of therapy, regardless of the level of clinical disease activity, and using Vectra scores to guide therapy should be an effective way to prevent radiographic progression. A recent prospective study of daily and diurnal variation in Vectra score established that the minimally important difference (MID) in Vectra score - i.e., the magnitude of change in Vectra score that is needed to be confident that it reflects real biologic change and is not due only to random variation - is greater than or equal to 8 Vectra units. Accordingly, a threshold of 8 can be used in guidances for using Vectra to evaluate treatment response.
The primary objective is to compare the clinical response from baseline to 12 months among patients with RA receiving Vectra-Guided care versus those receiving usual care.
The secondary objectives of this study are to:
3,332 studies on the registry are indexed under Arthritis, Rheumatoid; 443 are open to participants now.
This study's enrollment of 1,500 is above the median of 176 across 1,016 observational studies indexed under Arthritis, Rheumatoid.
Browse Arthritis, Rheumatoid studies →Sequenom, Inc. is the lead sponsor of 26 studies on the registry; 5 are open to participants now.
First submitted after Sequenom, Inc. became part of Labcorp.
Counted across the registry records on this site, refreshed daily.
Patients diagnosed with active rheumatoid arthritis at pre-determined clinical sites
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Physicians will use the reported Vectra score to guide treatment decisions
Diagnostic Test: Vectra
Physicians will treat patient per standard of care without the use of the Vectra score
Each arm will have the Vectra test however, scores will not be provided for the Usual Care Arm until end of study (12 month time point)
ACR20 response at 12 months
The primary endpoint of this study is ACR20 response, as compared between the guided-care arm and the usual care arm using a generalized estimating equation for logistic regression at six months that accounts for differences in baseline risk factors between the two arms and intracluster correlation induced by site cluster randomization.
Time frame: Baseline visit to 12 months
Radiographic progression at 1 year
A secondary endpoint of this study is the rate of radiographic progression at 1 year, as measured by the change (Δ) in modified total Sharp score (mTSS) from baseline to 1 year.
Time frame: Baseline to 12 months (1 year)
Change in Vectra score
Another secondary endpoint of this study is the change in Vectra score.
Time frame: Baseline to 6 months, and baseline and 12 months (1 year)
ACR20 response at 6 months
Another secondary endpoint of this study is ACR20 response, as compared between the guided-care arm and the usual care arm using a generalized estimating equation for logistic regression at 12 months (1 year) that accounts for differences in baseline risk factors between the two arms and intracluster correlation induced by site cluster randomization.
Time frame: Baseline to 12 months (1 year)
Exploring a change in the definition of non-progression less than or equal to 5
The percentage of patients with radiographic non-progression, defined as ΔmTSS less than or equal to 5 from baseline to 1 year.
Time frame: Baseline to 12 months (1 year)
Exploring a change in the definition of non-progression less than or equal to 3
The percentage of patients with radiographic non-progression, defined as ΔmTSS less than or equal to 3 from baseline to 1 year.
Time frame: Baseline to 12 months (1 year)
Change in physical function measured by HAQ-D1
Change in physical function measured by the Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: Baseline to 12 months (1 year)
Change in clinical disease activity measured by Patient Reported Outcomes Measurement Information System (PROMIS)
Change in clinical disease activity measured by PROMIS (Fatigue, Pain Interference, and Social Participation).PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions.
Time frame: Baseline to 12 months (1 year)
Change in physical function measured by PROMIS
Change in physical function measured by the Patient Reported Outcomes Measurement Information System (PROMIS) physical function 10 (PF10). PROMIS® (Patient-Reported Outcomes Measurement Information System) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in adults and children. It can be used with the general population and with individuals living with chronic conditions.
Time frame: Baseline to 12 months (1 year)
Change in clinical disease activity measured by RAPID3
Change in clinical disease activity measured by Routine Assessment of Patient Index Data 3 (RAPID3)
Time frame: Baseline to 12 months (1 year)
Change in clinical disease activity measured by CDAI
Change in clinical disease activity measured by the Clinical Disease Activity Index (CDAI)
Time frame: Baseline to 12 months (1 year)
Change in clinical disease activity measured by SDAI
Change in clinical disease activity measured by the Simplified Disease Activity Index (SDAI)
Time frame: Baseline to 12 months (1 year)
Change in clinical disease activity measured by DAS28-CRP
Change in clinical disease activity measured by the Disease Activity Score 28-joint count C reactive protein (DAS28-CRP)
Time frame: Baseline to 12 months (1 year)
The frequency of changes in RA medications [non-biologic, biologic, or targeted synthetic disease modifying anti-rheumatic drugs (DMARDs)]
Defined as the number of changes per subject per year in type or dosage of prescribed RA medication during the study period.
Time frame: Baseline to 12 months (1 year)
Plan to share: No
No publications or documents are linked to this record.
Ran from Jun 2019 to primary completion in Jul 2026, 84 months.
Of 155 industry-sponsored observational studies under Arthritis, Rheumatoid, half reached primary completion within 61 months of starting (the median), counting those still running; a quarter within 32 and three quarters within 116. This study's 84 months is above that.
Counting every sponsor, half of 389 studies reached it within 50 months; a quarter within 25 and three quarters within 113.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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