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NCT03631225 · ClinicalTrials.gov registry record

The Effect of Guided Care With Vectra Compared to Treatment as Usual in Patients With Rheumatoid Arthritis

A clinical trial of Rheumatoid Arthritis (RA), sponsored by Sequenom.

Active
Registry status
1,500
Enrollment target
20
Study locations

NCT03631225: Active study of Rheumatoid Arthritis (RA), sponsored by Sequenom.

NCT03631225 is a study of Rheumatoid Arthritis (RA) that is active but no longer recruiting, run by Sequenom. The registered enrollment target is 1,500 participants, above the 180-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target (733% higher). The trial reports 20 study locations across 9 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03631225, a study of Rheumatoid Arthritis (RA), is active but no longer recruiting, sponsored by Sequenom.

ACTIVE NOT RECRUITING
Registry status
1,500 participants
Enrollment target
20
Study locations

Study Summary

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.

Primary Outcome

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.

Conditions Studied

Rheumatoid Arthritis (RA)

Interventions

  • DIAGNOSTIC_TEST Vectra

Study Locations (20)

Florida

  • AARDS Research, Inc. - Aventura
  • Robert W. Levin, MD, PA - Clearwater
  • Artemisa Analytics - Miami
  • Rheumatology Associates of Central Florida, P.A. - Orlando
  • Clin-Med Research & Development, LLC - South Miami

Pennsylvania

  • East Penn Rheumatology Associates, P.C. - Bethlehem
  • Altoona Center for Clinical Research - Duncansville
  • Advanced Rheumatology & Arthritis Research Center, PC - Wexford
  • PA Regional Center for Arthritis and Osteoporosis Research - Wyomissing

California

  • Bio Solutions Clinical Research - La Mesa
  • Brigid Freyne, MD - Murrieta
  • J. Lee MD Medical Corp - Orange

Louisiana

  • Accurate Clinical Research - Lake Charles
  • Arthritis and Diabetes Clinic, Inc. - Monroe

Ohio

  • Paramount Medical Research & Consulting, LLC - Middleburg Heights
  • Southern Ohio Rheumatology Inc. - Wheelersburg

Delaware

  • Delaware Arthritis - Lewes

Mississippi

  • North Mississippi Medical Center - Tupelo

Missouri

  • Clinvest Research, LLC. - Springfield

Trial Details

FieldValue
Enrollment Target 1,500 participants
Start Date 2019-06-25
Est. Completion 2026-04-15
Sequenom

26 total trials

What the registry record for NCT03631225 still lists

NCT03631225 is an observational study that tracks outcomes without assigning an intervention. Its 1,500 participants enrollment target places it among the larger protocols in the corpus, above the 180-participant average among 17 other Rheumatoid Arthritis (RA) trials with a reported enrollment target (733% higher).

The record links to 1 condition, with Rheumatoid Arthritis (RA) appearing as the primary indexed condition, and to 1 intervention - of which Vectra is the first listed.

NCT03631225 names 20 study sites across 9 states, led by Florida, Pennsylvania, California.

Frequently Asked Questions

What is clinical trial NCT03631225 about?

NCT03631225 is a clinical study titled "The Effect of Guided Care With Vectra Compared to Treatment as Usual in Patients With Rheumatoid Arthritis". 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 neede...

What is the current status of trial NCT03631225?

This trial is currently active not recruiting. The enrollment target is 1,500 participants. The study started on 2019-06-25. Estimated completion is 2026-04-15.

What conditions does trial NCT03631225 study?

This clinical trial studies the following conditions: Rheumatoid Arthritis (RA).

What interventions are being tested in trial NCT03631225?

The interventions under investigation include: Vectra (DIAGNOSTIC_TEST).

Who is sponsoring clinical trial NCT03631225?

This trial is sponsored by Sequenom, which has 26 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT03631225 being conducted?

This trial has 20 study locations across California, Delaware, Florida, Louisiana, Mississippi. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Learn More About Clinical Trials

Similar trials for Rheumatoid Arthritis (RA)

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT03631225's enrollment target sits among peer trials

1,500 1st of 17 higher than 17 of 17 other Rheumatoid Arthritis (RA) trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Rheumatoid Arthritis (RA) trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Related registry views

Source: ClinicalTrials.gov NCT03631225, the US trial registry maintained by the National Library of Medicine. NCT03631225 (large enrollment · wide site footprint · active not recruiting) retrieved and formatted by PlainTrial, see methodology.