The Predictive Value of Ultrasound in Early Rheumatoid Arthritis (EVA)
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.
Predictive Value of Ultrasound in Early Rheumatoid Arthritis
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||The Predictive Value of Ultrasound in Early Rheumatoid Arthritis|
- 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 ] [ Designated as safety issue: No ]
- Change in Sharp vd Heijde score during the year of inclusion [ Time Frame: At date of inclusion and after one year ] [ Designated as safety issue: No ]
- Change of DAS over time [ Time Frame: At date of inclusion, after 3 months and after one year ] [ Designated as safety issue: No ]
|Study Start Date:||June 2010|
|Estimated Study Completion Date:||July 2013|
|Estimated Primary Completion Date:||July 2013 (Final data collection date for primary outcome measure)|
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.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01752309
|Contact: David F. Ten Cate, MDfirstname.lastname@example.org|
|Contact: Jolanda J. Luime, PhDemail@example.com|
|Medical Center Alkmaar||Recruiting|
|Alkmaar, Noord Holland, Netherlands, 1815JD|
|Principal Investigator: Nanno A.A. Swen, MD, PhD|
|Almelo, Overijssel, Netherlands, 7609PP|
|Principal Investigator: Cees Haagsma, MD, PhD|
|Albert Schweitzer Hospital||Recruiting|
|Dordrecht, Zuid Holland, Netherlands, 3300AK|
|Principal Investigator: Mike H De Jager, MD|
|Erasmus Medical Center||Recruiting|
|Rotterdam, Zuid Holland, Netherlands, 3015GE|
|Principal Investigator: David F. Ten Cate, MD|
|Rotterdam, Zuid Holland, Netherlands, 3079DZ|
|Principal Investigator: Natalja M Basoski, MD|
|Schiedam, Zuid Holland, Netherlands, 3118JH|
|Principal Investigator: Andreas H Gerards, MD|
|University Medical Center Utrecht||Recruiting|
|Utrecht, Netherlands, 3584CX|
|Principal Investigator: Johannes W.G. Jacobs, MD, PhD|
|Principal Investigator:||Jolanda J. Luime, PhD||Erasmus Medical Center|