The Predictive Value of Ultrasound in Early Rheumatoid Arthritis (EVA)
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|ClinicalTrials.gov Identifier: NCT01752309|
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : November 19, 2014
|Condition or disease|
|Rheumatoid Arthritis Predictive Value of Ultrasound in Early Rheumatoid Arthritis|
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|
|Actual Enrollment :||150 participants|
|Official Title:||The Predictive Value of Ultrasound in Early Rheumatoid Arthritis|
|Study Start Date :||June 2010|
|Actual Primary Completion Date :||July 2013|
|Actual Study Completion Date :||July 2013|
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.
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01752309
|Medical Center Alkmaar|
|Alkmaar, Noord Holland, Netherlands, 1815JD|
|Almelo, Overijssel, Netherlands, 7609PP|
|Albert Schweitzer Hospital|
|Dordrecht, Zuid Holland, Netherlands, 3300AK|
|Erasmus Medical Center|
|Rotterdam, Zuid Holland, Netherlands, 3015GE|
|Rotterdam, Zuid Holland, Netherlands, 3079DZ|
|Schiedam, Zuid Holland, Netherlands, 3118JH|
|University Medical Center Utrecht|
|Utrecht, Netherlands, 3584CX|
|Principal Investigator:||Jolanda J. Luime, PhD||Erasmus Medical Center|