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临床试验/NCT02684695
NCT02684695招募中不适用

The Development and Validation of Quantitative Imaging Biomarkers as a Measure of Disease Activity in Juvenile Idiopathic Arthritis

University College London Hospitals1 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2016年1月最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
发起方
入组人数
200
试验地点
1
主要终点
Percentage agreement between novel biomarker measurements (apparent diffusion coefficient and fat fraction) and existing scores of inflammation (SPARCC STIR score)

研究概览

简要总结

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).

详细描述

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.

  1. 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. 2. Study Design

Patients will be divided according to diagnostic group - group A will consist of patients with ERA (and also controls who are subsequently diagnosed with mechanical back pain), while group B will consist of patients with ERA, extended oligo- and polyarthritis. As detailed below, the scan protocol will be different for these two groups. JIA patients in both groups will be scanned at enrolment and will have repeat scans every 6-12 months, depending on clinical need, for up to five years in total. Thereafter, scans will be performed as defined by the requirements of their clinical care up to year 10 of study. The control group in group A will only be scanned once. They will be asked to provide written consent prior to enrolling. The imaging component of the study will run for up to five years in total, and approximately 200 patients will be recruited in total.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
12 Years 至 24 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Participant is willing and able to give informed consent for participation in the study.
  • For cases, patients will have clinical diagnosis of JIA: enthesitis-related arthropathy, extended oligoarthritis or polyarthritis (defined according to ILAR criteria)
  • For controls, patients will have a diagnosis of mechanical back pain (though to arise from muscles, bones, ligaments or discs), with normal inflammatory markers
  • Age 12-24

排除标准

  • Contra-indication to MRI scan (e.g. metal foreign object)
  • Unable to give consent
  • Unable to speak English
  • Unable to tolerate an MRI scan (e.g. due to claustrophobia, contrast allergy)
  • Renal or hepatic failure (eGFR < 30ml/min for renal failure, where applicable)

结局指标

主要结局

Percentage agreement between novel biomarker measurements (apparent diffusion coefficient and fat fraction) and existing scores of inflammation (SPARCC STIR score)

时间窗: 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.

次要结局

  • Scoring systems for whole body imaging, and novel approaches to measuring bone marrow disease(5 years)

研究者

发起方
University College London Hospitals
申办方类型
Other
责任方
Principal Investigator
主要研究者

Timothy Bray

Radiology SpR and PhD student

University College London Hospitals

研究点 (1)

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