The Predictive Value of Ultrasound in Early Rheumatoid Arthritis

Completed

• Conditions: Rheumatoid Arthritis; Predictive Value of Ultrasound in Early Rheumatoid Arthritis

• Registration Number: NCT01752309
• Lead Sponsor: 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.

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 Timeline

• Study Start: 2010-06
• Study First Submitted: 2012-12-12
• Study First Submitted QC: 2012-12-14
• Study First Posted: 2012-12-19
• Primary Completion: 2013-07
• Study Completion: 2013-07
• Status Verified: 2014-11
• Last Update Submitted: 2014-11-18
• Last Update Posted: 2014-11-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
Change in Sharp vd Heijde score during the year of inclusion	At date of inclusion and after one year

Trial Locations

Locations (7)

Erasmus Medical Center; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

Ziekenhuisgroep Twente; 🇳🇱 Almelo, Overijssel, Netherlands

Albert Schweitzer Hospital; 🇳🇱 Dordrecht, Zuid Holland, Netherlands

Vlietland Hospital; 🇳🇱 Schiedam, Zuid Holland, Netherlands

Medical Center Alkmaar; 🇳🇱 Alkmaar, Noord Holland, Netherlands

Maasstad Hospital; 🇳🇱 Rotterdam, Zuid Holland, Netherlands

University Medical Center Utrecht; 🇳🇱 Utrecht, Netherlands