Magnetic resonance Imaging (MRI) inflammation as an imaging biomarker in rheumatoid arthritis: monitoring response to the Treat to Target” approach
Not Applicable
Active, not recruiting
- Conditions
- rheumatoid arthritisInflammatory and Immune System - Rheumatoid arthritis
- Registration Number
- ACTRN12614000895684
- Lead Sponsor
- Prof Fiona McQueen
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Active, not recruiting
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
seropositive rheumatoid arthritis
Willing and eligible for disease modifying therapy including methotrexate, combination DAMRDS and /or anti-TNF therapy as per treating clinician's decision
Willing and eligible to have 2 contrast-enhanced MRI scans (no contraindications)
Exclusion Criteria
Contraindications to the medical therapies for rheumatoid arthritis as outlined above
Patients will be excluded if there are contraindications to MRI scanning (obesity, claustrophobia, internal metalware) or have impaired renal function and cannot be given IV gadolinium (creatinine clearance must be > 60ml/min).
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in MRI inflammation score including scores for synovitis, osteitis and tenosynovitis. These will be assessed by the OMERACT RA-MRI scoring system (RAMRIS) and the tenosynovitis score will be assessed according to the method described by Haarvardsholm et al.Annals of the Rheumatic Diseases, 2007. 66(9): p. 1216-20.[Scores will be assessed at baseline and then 3 months after the change in therapy]
- Secondary Outcome Measures
Name Time Method Change in Disease activity score (DAS) 28CRP SF-36[3 months];change in 66 swollen joint counts,[3 months];change in 68 tender joint count[3 months];change in visual analogue pain score (100mm)[3 months];change in visual analogue general health score (patient)[3 months];change in Health Assessment Questionnaire (HAQ) score, [3 months];change in Sharp van der Heijde joint damage score[2 years];change in CRP (measured using serum assay).[3 months]