Quantitative MRI to define mechanisms of cardiovascular co-morbidity in patients with early Rheumatoid Arthritis and to measure the effect of biological therapy: a randomised controlled trial

niversity of Leeds (UK)0 sites100 target enrollmentNovember 8, 2013

Overview

Registry

who.int

Start Date

November 8, 2013

End Date

January 31, 2015

Last Updated

7 years ago

Study Type

Interventional

Sex

All

Sponsor

niversity of Leeds (UK)

•1\. Males and females
•2\. Aged between 18 and 80 years
•3\. Diagnosed with RA according to 2010 ACR/EULAR criteria
•4\. Who have not yet received therapy with disease modifying drugs
•5\. Have early (symptoms for less than 1 year)
•6\. Active disease (clinical or imaging evidence of synovitis and DAS28\- ESR \>/\= 3\.2\)
•7\. At least one poor prognostic factor (anti\-citrullinated peptide antibody \+/\- abnormal power Doppler in at least 1 joint)
•1\. Males and females without RA
•2\. Aged between 18 and 80 years
•3\. Matched for age and blood pressure

•1\. Previous treatment with DMARDs
•2\. Contraindications to MRI and to anti\-TNF therapy and severe co\-morbidity that would in the clinician?s opinion be associated with unacceptable risk of receiving potentially anti\-TNF therapy
•3\. Contraindications to MRI (incompatible metallic implants, pacemakers)
•4\. Renal failure (eGFR\<30 ml/min/1\.73m2\)
•5\. Previous allergic reactions to MRI contrast agents
•6\. Known cardiovascular disease (CVD)
•7\. Contraindications to adenosine (asthma or high grade heart block)
•1\. History of RA or other inflammatory disease
•2\. Contraindications to MRI
•3\. Contrast agents or adenosine or presence of renal failure as defined above