Clinical trial NCT01752309: The Predictive Value of Ultrasound in Early Rheumatoid Arthritis
Official title: The Predictive Value of Ultrasound in Early Rheumatoid Arthritis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rheumatoid Arthritis
Predictive Value of Ultrasound in Early Rheumatoid Arthritis
Keywords: Early Rheumatoid arthritis
Rheumatoid arthritis
Ultrasound
Predictive
Prognosis
Lead sponsor: Erasmus Medical Center
Sponsor class: OTHER
Collaborators: name: Maasstad Hospital
name: Albert Schweitzer Hospital
name: Vlietland Ziekenhuis
name: UMC Utrecht
name: Medical Center Alkmaar
name: Ziekenhuisgroep Twente
First posted: 2012-12-19
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.

Eligibility 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

Primary outcomes:
measure: Persistence of active disease after one year, defined as a Disease Activity Score of 44 joints (DAS44) > 3.4
timeFrame: One year after inclusion in the study
Secondary outcomes:
measure: Change in Sharp vd Heijde score during the year of inclusion
timeFrame: At date of inclusion and after one year
Other outcomes:
measure: Change of DAS over time
timeFrame: At date of inclusion, after 3 months and after one year
Locations:
city: Alkmaar
country: Netherlands
facility: Medical Center Alkmaar
state: Noord Holland
city: Almelo
country: Netherlands
facility: Ziekenhuisgroep Twente
state: Overijssel
city: Dordrecht
country: Netherlands
facility: Albert Schweitzer Hospital
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Erasmus Medical Center
state: Zuid Holland
city: Rotterdam
country: Netherlands
facility: Maasstad Hospital
state: Zuid Holland
city: Schiedam
country: Netherlands
facility: Vlietland Hospital
state: Zuid Holland
city: Utrecht
country: Netherlands
facility: University Medical Center Utrecht
Study officials:
affiliation: Erasmus Medical Center
name: Jolanda J. Luime, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.