NCT02464384

Prediction of Erosive Disease in Early Rheumatoid Arthritis (RA) by Ultrasound and Cartilage Biodegradation Markers

Multicenter, Prospective, Open-label, Cohort Study With Collection of Blood Samples and Ultrasound / MRI and X-ray Examination

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Zurich · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

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

Conditions

• Erosive Disease in Early Rheumatoid Arthritis

Interventions

Type	Name	Description
PROCEDURE	Venipuncture, ultrasound, MRI, x-ray	Collection of blood samples and ultrasound / MRI and x-ray examination

Timeline

• Start date: 2016-04-01
• Primary completion: 2019-04-01
• Completion: 2019-10-01
• First posted: 2015-06-08
• Last updated: 2015-12-03