Clinical Trial: Juvenile Arthritis Quantitative Imaging
Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational
Official Title: The Development and Validation of Quantitative Imaging Biomarkers as a Measure of Disease Activity in Juvenile Idiopathic Arthritis
Brief Summary: This observational study aims to develop and validate quantitative magnetic resonance imaging biomarkers as measures of disease activity in juvenile idiopathic arthritis (JIA). This includes patients with enthesitis-related arthritis (ERA).
Detailed Summary:
This body of research will comprise a number of sub-studies, each designed to evaluate the use of quantitative MRI in JIA. Although patients will receive treatment during the study, this will form part of their routine clinical care and therefore this study is best regarded as observational.
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Subjects and recruitment
Patients will be recruited by clinical rheumatologists working in a specialist adolescent and young adult inflammatory arthritis tertiary referral centre, on a person-to-person basis. Patients will be aged 12-24 and have a diagnosis of JIA according to established clinical criteria.8,9 Individuals with enthesitis-related arthropathy and those with other forms of JIA (extended oligorticular and polyarthritis (rheumatoid factor positive and negative)) will be divided into separate groups and asked to have an MRI scan. Control subjects will be recruited from the same clinic, and will consist of individuals with mechanical back pain (non-inflammatory - thought to arise from vertebrae, discs or ligaments) and normal inflammatory markers. Such patients still require an MRI scan as part of their routine care to confirm the mechanical cause for their back pain and definitively rule out inflammation as a cause, but serve as non-inflammatory controls. All patients will be asked to provide written consent at the time of enrolment.
Patients will include both patients with a new diagnosis of JIA and those with established disease who are already on treatment. For obvious ethical reasons, patients will not be divided into different treatment groups.
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Study Design
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Sponsor: University College London Hospitals
Current Primary Outcome: Percentage agreement between novel biomarker measurements (apparent diffusion coefficient and fat fraction) and existing scores of inflammation (SPARCC STIR score) [ Time Frame: 5 years ]
NB: Agreement is a single statistical parameter which is derived by comparison of two measurements - it is this parameter (rather than the measurements) which is the outcome measure.
Original Primary Outcome: Same as current
Current Secondary Outcome: Scoring systems for whole body imaging, and novel approaches to measuring bone marrow disease [ Time Frame: 5 years ]
Original Secondary Outcome: Same as current
Information By: University College London Hospitals
Dates:
Date Received: February 10, 2016
Date Started: January 2016
Date Completion: January 2026
Last Updated: October 24, 2016
Last Verified: October 2016
