The Predictive Value of Ultrasound in Early Rheumatoid Arthritis

Rheumatoid Arthritis Clinical Trial

— EVA  

Official title:

The Predictive Value of Ultrasound in Early Rheumatoid Arthritis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01752309
• Other study ID #: MEC2009-333
• Secondary ID: NL28038.078.09
• Status: Completed
• Phase: N/A
• First received: December 12, 2012
• Last updated: November 18, 2014
• Start date: June 2010
• Est. completion date: July 2013

Study information

• Verified date: November 2014
• Source: Erasmus Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Rheumatoid
• Predictive Value of Ultrasound in Early Rheumatoid Arthritis
• Rheumatoid Arthritis

Locations

Country	Name	City	State
Netherlands	Medical Center Alkmaar	Alkmaar	Noord Holland
Netherlands	Ziekenhuisgroep Twente	Almelo	Overijssel
Netherlands	Albert Schweitzer Hospital	Dordrecht	Zuid Holland
Netherlands	Erasmus Medical Center	Rotterdam	Zuid Holland
Netherlands	Maasstad Hospital	Rotterdam	Zuid Holland
Netherlands	Vlietland Hospital	Schiedam	Zuid Holland
Netherlands	University Medical Center Utrecht	Utrecht

Sponsors (7)

Lead Sponsor	Collaborator
Erasmus Medical Center	Albert Schweitzer Hospital, Maasstad Hospital, Medical Center Alkmaar, UMC Utrecht, Vlietland Ziekenhuis, Ziekenhuisgroep Twente

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Change of DAS over time		At date of inclusion, after 3 months and after one year	No
Primary	Persistence of active disease after one year, defined as a Disease Activity Score of 44 joints (DAS44) > 3.4		One year after inclusion in the study	No
Secondary	Change in Sharp vd Heijde score during the year of inclusion		At date of inclusion and after one year	No