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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Erasmus Medical Center
Sponsor:
Collaborators:
Maasstad Hospital
Albert Schweitzer Hospital
Vlietland Hospital Schiedam
UMC Utrecht
Medical Center Alkmaar
Ziekenhuisgroep Twente
Information provided by (Responsible Party):
Ten Cate, Erasmus Medical Center
ClinicalTrials.gov Identifier:
NCT01752309
First received: December 12, 2012
Last updated: December 20, 2012
Last verified: December 2012
  Purpose

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
Rheumatoid Arthritis
Predictive Value of Ultrasound in Early Rheumatoid Arthritis

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: The Predictive Value of Ultrasound in Early Rheumatoid Arthritis

Resource links provided by NLM:


Further study details as provided by Erasmus Medical Center:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Other Outcome Measures:
  • Change of DAS over time [ Time Frame: At date of inclusion, after 3 months and after one year ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
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)
Groups/Cohorts
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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.

Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01752309

Contacts
Contact: David F. Ten Cate, MD 0031107038251 d.tencate@erasmusmc.nl
Contact: Jolanda J. Luime, PhD 0031107034264 j.luime@erasmusmc.nl

Locations
Netherlands
Medical Center Alkmaar Recruiting
Alkmaar, Noord Holland, Netherlands, 1815JD
Principal Investigator: Nanno A.A. Swen, MD, PhD         
Ziekenhuisgroep Twente Recruiting
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         
Maasstad Hospital Recruiting
Rotterdam, Zuid Holland, Netherlands, 3079DZ
Principal Investigator: Natalja M Basoski, MD         
Vlietland Hospital Recruiting
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         
Sponsors and Collaborators
Erasmus Medical Center
Maasstad Hospital
Albert Schweitzer Hospital
Vlietland Hospital Schiedam
UMC Utrecht
Medical Center Alkmaar
Ziekenhuisgroep Twente
Investigators
Principal Investigator: Jolanda J. Luime, PhD Erasmus Medical Center
  More Information

No publications provided

Responsible Party: Ten Cate, David F. Ten Cate, MD, Erasmus Medical Center
ClinicalTrials.gov Identifier: NCT01752309     History of Changes
Other Study ID Numbers: MEC2009-333, NL28038.078.09
Study First Received: December 12, 2012
Last Updated: December 20, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Erasmus Medical Center:
Early Rheumatoid arthritis
Rheumatoid arthritis
Ultrasound
Predictive
Prognosis

Additional relevant MeSH terms:
Arthritis
Arthritis, Rheumatoid
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on October 19, 2014