COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

The Predictive Value of Ultrasound in Early Rheumatoid Arthritis (EVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01752309
Recruitment Status : Completed
First Posted : December 19, 2012
Last Update Posted : November 19, 2014
Maasstad Hospital
Albert Schweitzer Hospital
Vlietland Ziekenhuis
UMC Utrecht
Medical Center Alkmaar
Ziekenhuisgroep Twente
Information provided by (Responsible Party):
Ten Cate, Erasmus Medical Center

Brief Summary:
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.

Condition or disease
Rheumatoid Arthritis Predictive Value of Ultrasound in Early Rheumatoid Arthritis

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.

Layout table for study information
Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Cohort
Time Perspective: Prospective
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

Resource links provided by the National Library of Medicine

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.

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Change in Sharp vd Heijde score during the year of inclusion [ Time Frame: At date of inclusion and after one year ]

Other Outcome Measures:
  1. Change of DAS over time [ Time Frame: At date of inclusion, after 3 months and after one year ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Starting in June 2010, all newly diagnosed rheumatoid arthritis patients who will be participating in 2 ongoing trials will be invited to participate in this study. In Almelo they will be recruited from the outpatient Rheumatology clinic.

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

Information from the National Library of Medicine

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 identifier (NCT number): NCT01752309

Layout table for location information
Medical Center Alkmaar
Alkmaar, Noord Holland, Netherlands, 1815JD
Ziekenhuisgroep Twente
Almelo, Overijssel, Netherlands, 7609PP
Albert Schweitzer Hospital
Dordrecht, Zuid Holland, Netherlands, 3300AK
Erasmus Medical Center
Rotterdam, Zuid Holland, Netherlands, 3015GE
Maasstad Hospital
Rotterdam, Zuid Holland, Netherlands, 3079DZ
Vlietland Hospital
Schiedam, Zuid Holland, Netherlands, 3118JH
University Medical Center Utrecht
Utrecht, Netherlands, 3584CX
Sponsors and Collaborators
Erasmus Medical Center
Maasstad Hospital
Albert Schweitzer Hospital
Vlietland Ziekenhuis
UMC Utrecht
Medical Center Alkmaar
Ziekenhuisgroep Twente
Layout table for investigator information
Principal Investigator: Jolanda J. Luime, PhD Erasmus Medical Center
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Ten Cate, David F. Ten Cate, MD, Erasmus Medical Center Identifier: NCT01752309    
Other Study ID Numbers: MEC2009-333
NL28038.078.09 ( Registry Identifier: CCMO )
First Posted: December 19, 2012    Key Record Dates
Last Update Posted: November 19, 2014
Last Verified: November 2014
Keywords provided by Ten Cate, Erasmus Medical Center:
Early Rheumatoid arthritis
Rheumatoid arthritis
Additional relevant MeSH terms:
Layout table for MeSH terms
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases