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The Predictive Value of Ultrasound in Early Rheumatoid Arthritis

The Predictive Value of Ultrasound in Early Rheumatoid Arthritis

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01752309
Acronym
EVA
Enrollment
150
Registered
2012-12-19
Start date
2010-06-30
Completion date
2013-07-31
Last updated
2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Predictive Value of Ultrasound in Early Rheumatoid Arthritis, Rheumatoid Arthritis

Keywords

Early Rheumatoid arthritis, Rheumatoid arthritis, Ultrasound, Predictive, Prognosis

Brief summary

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.

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.

Interventions

None listed

Sponsors

Maasstad Hospital
CollaboratorOTHER
Albert Schweitzer Hospital
CollaboratorOTHER
Vlietland Ziekenhuis
CollaboratorOTHER
UMC Utrecht
CollaboratorOTHER
Medical Center Alkmaar
CollaboratorOTHER
Ziekenhuisgroep Twente
CollaboratorOTHER
Erasmus Medical Center
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Persistence of active disease after one year, defined as a Disease Activity Score of 44 joints (DAS44) > 3.4One year after inclusion in the study

Secondary

MeasureTime frame
Change in Sharp vd Heijde score during the year of inclusionAt date of inclusion and after one year

Other

MeasureTime frame
Change of DAS over timeAt date of inclusion, after 3 months and after one year

Countries

Netherlands

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026