The Predictive Value of Ultrasound in Early Rheumatoid Arthritis (EVA)

November 18, 2014 updated by: Ten Cate, Erasmus Medical Center
Rheumatoid arthritis a chronic and progressive inflammatory disease characterized by synovial membrane inflammation, possibly leading to destruction of joints. To start early with a combination therapy results in a better outcome for patients. Using ultrasonography it is possible to detect clinically and radiographically absent synovitis and erosions. However, it is unclear whether or not these findings have predictive value in these patients regarding disease activity or radiographical progression.

Study Overview

Detailed Description

Patients will be evaluated using the standard diagnostic workup of patients with early arthritis. This includes history taking, physical examination, Disease Activity Score of 44 joints (DAS44) and a laboratory test, including C-Reactive Protein(CRP), Erythrocyte Sedimentation Rate (ESR), Complete Blood Count (CBC), Rheumatoid Factor (RF), Anti-Cyclic Citrullinated Peptide(anti-CCP), transaminases, urinanalysis.

Also part of the standard workup for these patients are X-Rays of hands and feet to detect erosions. The baseline medication will include - in concordance with European League Against Rheumatism (EULAR)-guidelines and the provisional 'Nederlandse Vereniging voor Reumatologie(NVR)'-guidelines - Methotrexate (MTX) for all patients. The medicine regimes are part of the ongoing cohort studies from which the patients will be recruited. Evaluating the medicine effects is not part of the 'Echografie bij Vroege Artritis (EVA)(Ultrasound in Early Arthritis)' study. All consecutive Rheumatoid Arthritis (RA) patients will be asked to participate in this study. They will receive oral and written information about the EVA study.

Approximately two weeks after this first consultation the patient returns to his or her rheumatologist for the diagnosis and accompanying treatment. If the patient decides to participate in this study they fill out the informed consent form. The patient will be asked to fill out the Health Assessment Questionnaire (HAQ) and the Short Form-36 (SF-36). After this, at baseline, at three months and at 12 months, Metatarsophalangeal (MTP) 2-5(dorsal aspect) and Metacarpophalangeal (MCP) 2-5(dorsal, palmar, lateral) and wrists of each patient will be examined with ultrasound by a single rheumatologist per centre specialized in Ultrasound (US). This rheumatologist will be unaware of the clinical, laboratory and radiographic findings.

Study Type

Observational

Enrollment (Actual)

150

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Utrecht, Netherlands, 3584CX
        • University Medical Center Utrecht
    • Noord Holland
      • Alkmaar, Noord Holland, Netherlands, 1815JD
        • Medical Center Alkmaar
    • Overijssel
      • Almelo, Overijssel, Netherlands, 7609PP
        • Ziekenhuisgroep Twente
    • Zuid Holland
      • Dordrecht, Zuid Holland, Netherlands, 3300AK
        • Albert Schweitzer Hospital
      • Rotterdam, Zuid Holland, Netherlands, 3015GE
        • Erasmus Medical Center
      • Rotterdam, Zuid Holland, Netherlands, 3079DZ
        • Maasstad Hospital
      • Schiedam, Zuid Holland, Netherlands, 3118JH
        • Vlietland Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Starting in June 2010, all newly diagnosed rheumatoid arthritis patients who will be participating in 2 ongoing trials will be invited to participate in this study. In Almelo they will be recruited from the outpatient Rheumatology clinic.

Description

Inclusion Criteria:

  • Newly diagnosed rheumatoid arthritis patients, diagnosed according to the American College of Rheumatology (ACR) 1987-criteria
  • Naïve for Disease Modifying Anti Rheumatic Drugs (DMARDs), biologicals and glucocorticoids.
  • Starting with treatment with a potent anti-rheumaticum. E.g. methotrexate (MTX), biologicals or glucocorticoids.

Exclusion Criteria:

  • Contra-indications for MTX, biologicals or glucocorticoids.
  • Insufficient ability to read and write in Dutch
  • Personality disorders that limit the participation in the study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Rheumatoid Arthritis, ultrasound, persistence disease activity
Patients diagnosed with early Rheumatoid Arthritis will be assessed three times in one year with ultrasound to evaluate the predictive value of ultrasound.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Persistence of active disease after one year, defined as a Disease Activity Score of 44 joints (DAS44) > 3.4
Time Frame: One year after inclusion in the study
One year after inclusion in the study

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in Sharp vd Heijde score during the year of inclusion
Time Frame: At date of inclusion and after one year
At date of inclusion and after one year

Other Outcome Measures

Outcome Measure
Time Frame
Change of DAS over time
Time Frame: At date of inclusion, after 3 months and after one year
At date of inclusion, after 3 months and after one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jolanda J. Luime, PhD, Erasmus Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2010

Primary Completion (Actual)

July 1, 2013

Study Completion (Actual)

July 1, 2013

Study Registration Dates

First Submitted

December 12, 2012

First Submitted That Met QC Criteria

December 14, 2012

First Posted (Estimate)

December 19, 2012

Study Record Updates

Last Update Posted (Estimate)

November 19, 2014

Last Update Submitted That Met QC Criteria

November 18, 2014

Last Verified

November 1, 2014

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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