An observational study in Rheumatoid Arthritis and Predictive Value of Ultrasound in Early Rheumatoid Arthritis, sponsored by Erasmus Medical Center. Completed at 7 sites in Netherlands. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-11-19.
Sponsored by Erasmus Medical Center · Observational
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.
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.
3,554 studies on the registry are indexed under Arthritis; 317 are open to participants now.
This study's enrollment of 150 is close to the median of 155 across 1,057 observational studies indexed under Arthritis.
Browse Arthritis studies →Erasmus Medical Center is the lead sponsor of 466 studies on the registry; 179 are open to participants now.
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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.
Exclusion Criteria:
Patients diagnosed with early Rheumatoid Arthritis will be assessed three times in one year with ultrasound to evaluate the predictive value of ultrasound.
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
Change in Sharp vd Heijde score during the year of inclusion
Time frame: At date of inclusion and after one year
Change of DAS over time
Time frame: At date of inclusion, after 3 months and after one year
This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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