The Predictive Value of Ultrasound in Early Rheumatoid Arthritis
NCT ID: NCT01752309
Last Updated: 2014-11-19
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
150 participants
OBSERVATIONAL
2010-06-30
2013-07-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
No interventions assigned to this group
Eligibility Criteria
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Inclusion 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
* Insufficient ability to read and write in Dutch
* Personality disorders that limit the participation in the study
18 Years
ALL
No
Sponsors
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Maasstad Hospital
OTHER
Albert Schweitzer Hospital
OTHER
Vlietland Ziekenhuis
OTHER
UMC Utrecht
OTHER
Medical Center Alkmaar
OTHER
Ziekenhuisgroep Twente
OTHER
Erasmus Medical Center
OTHER
Responsible Party
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Ten Cate
David F. Ten Cate, MD
Principal Investigators
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Jolanda J. Luime, PhD
Role: PRINCIPAL_INVESTIGATOR
Erasmus Medical Center
Locations
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Medical Center Alkmaar
Alkmaar, North Holland, Netherlands
Ziekenhuisgroep Twente
Almelo, Overijssel, Netherlands
Albert Schweitzer Hospital
Dordrecht, South Holland, Netherlands
Erasmus Medical Center
Rotterdam, South Holland, Netherlands
Maasstad Hospital
Rotterdam, South Holland, Netherlands
Vlietland Hospital
Schiedam, South Holland, Netherlands
University Medical Center Utrecht
Utrecht, Utrecht, Netherlands
Countries
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References
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Ten Cate DF, Jacobs JWG, Swen WAA, Hazes JMW, de Jager MH, Basoski NM, Haagsma CJ, Luime JJ, Gerards AH. Can baseline ultrasound results help to predict failure to achieve DAS28 remission after 1 year of tight control treatment in early RA patients? Arthritis Res Ther. 2018 Jan 30;20(1):15. doi: 10.1186/s13075-018-1514-2.
Other Identifiers
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NL28038.078.09
Identifier Type: REGISTRY
Identifier Source: secondary_id
MEC2009-333
Identifier Type: -
Identifier Source: org_study_id