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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:
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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
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24 participants in 1 patient group
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Adrian Ciurea, MD; Mariusz Wasila, MD
Data sourced from clinicaltrials.gov
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