Rheumatoid Arthritis Clinical Trial
Official title:
The Predictive Value of Ultrasound in Early Rheumatoid Arthritis
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.
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Observational Model: Cohort, Time Perspective: Prospective
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