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

University of Zurich (UZH)

Status

Unknown

Conditions

Erosive Disease in Early Rheumatoid Arthritis

Treatments

Procedure: Venipuncture, ultrasound, MRI, x-ray

Study type

Interventional

Funder types

Other

Identifiers

NCT02464384

UPEDRA01_01.07.2013

Details and patient eligibility

About

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

Full 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

Enrollment

24 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Patients fulfilling all of the following inclusion criteria may be enrolled in the study:
male and female subjects, Age above 18 yrs
recent onset RA fulfilling the American College of Rheumatology (ACR) criteria (revised 2010)
Symptoms for at least 6 weeks
no previous DMARD treatment
no intraarticular steroid injections in the last 4 weeks before inclusion
no treatment with oral steroids exceeding the equivalent of 10mg prednisone per day in the last 2 weeks before inclusion
signed Informed Consent after being informed

Exclusion criteria

History of inflammatory joint disease other than RA
History of active Tbc, histoplasmosis or listeriosis
History of lymphoma or other malignancies within 5 years
Contraindication for the use of DMARD's or biologics
Comorbidities: severe myocardial dysfunction, recent stroke (within 3 months), uncontrolled diabetes and other disease which in the opinion of the investigator, would put the subject at risk by participation in the trial
History of demyelinating disorders
persistent or recurrent infections
Pregnancy or breast feeding
no informed consent