- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01752309
The Predictive Value of Ultrasound in Early Rheumatoid Arthritis (EVA)
Study Overview
Status
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.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Utrecht, Netherlands, 3584CX
- University Medical Center Utrecht
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Noord Holland
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Alkmaar, Noord Holland, Netherlands, 1815JD
- Medical Center Alkmaar
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Overijssel
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Almelo, Overijssel, Netherlands, 7609PP
- Ziekenhuisgroep Twente
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Zuid Holland
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Dordrecht, Zuid Holland, Netherlands, 3300AK
- Albert Schweitzer Hospital
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Rotterdam, Zuid Holland, Netherlands, 3015GE
- Erasmus Medical Center
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Rotterdam, Zuid Holland, Netherlands, 3079DZ
- Maasstad Hospital
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Schiedam, Zuid Holland, Netherlands, 3118JH
- Vlietland Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
Cohorts and Interventions
Group / Cohort |
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
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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
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One year after inclusion in the study
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
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Change in Sharp vd Heijde score during the year of inclusion
Time Frame: At date of inclusion and after one year
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At date of inclusion and after one year
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Other Outcome Measures
Outcome Measure |
Time Frame |
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Change of DAS over time
Time Frame: At date of inclusion, after 3 months and after one year
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At date of inclusion, after 3 months and after one year
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jolanda J. Luime, PhD, Erasmus Medical Center
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- MEC2009-333
- NL28038.078.09 (Registry Identifier: CCMO)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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