Erosive Disease in Early Rheumatoid Arthritis Clinical Trial
Official title:
Multicenter, Prospective, Open-label, Cohort Study With Collection of Blood Samples and Ultrasound / MRI and X-ray Examination
Multicenter, prospective, open-label, cohort study. Primary objective: Determination of the
predictive value of US alone and in combination with cartilage biodegradation markers on
radiographic progression (change in Ratingen score)
Secondary objectives:
- Correlation of ultrasound synovitis score and clinical disease activity score
- Determination of the sensitivity of ultrasound erosion detection compared to MRI
- Assessment of the value of including tenosynovitis assessment for predicting
radiographic progression
- Assessment of the predictive value of ultrasound synovitis score at baseline for the
need to install biologic DMARDs
Multicenter, prospective, open-label, cohort study with collection of blood samples and
ultrasound / MRI and x-ray examination.
Duration of study: 12 months This study is a prospective cohort study. The choice of therapy
at any time during the study is entirely up to the treating rheumatologist. The study does
not put any restriction on the management of the patient which will be according to routine
care.
At occurrence of one or more of the above mentioned variables defining adverse clinical
outcome (prednisone in a dose exceeding 10mg/d and/or intraarticular steroid injections
and/or start of biologic DMARD) an analysis as for D360 will be performed US-Score:
SONAR-Score assessment of synovitis (22 joints)/erosions (14 joints)/cartilage thickness (8
joints) Clinical evaluation: Disease activity score (DAS28 = Number of tender and swollen
joints (0-28), additional measures (ESR / CRP), Patient Global Health (0-100), health
assessment questionnaire (HAQ) at 0, 3, 6, 9, 12 months (attached) Lab: ESR, CRP Serology:
Antinuclear antibody (ANA), Rheumatoid factor (RF), Anti-cyclic citrullinated peptide
(anti-CCP) at baseline if not available COL2-1 / COL2-1N X-Ray: hands and feet at baseline
and 12 months (scoring according to Ratingen Score) if not available MRI without contrast at
baseline and at 12 months or when first erosions detected with US
;
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic