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临床试验/NCT03817983
NCT03817983已完成不适用

Magnetic Resonance Enterography as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease: A Prospective Single-center Cross-sectional Observational Study Using MRE Screening Followed by Clinical Assessment

Cambridge University Hospitals NHS Foundation Trust1 个研究点 分布在 1 个国家目标入组 259 人开始时间: 2019年3月4日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
259
试验地点
1
主要终点
The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease

研究概览

简要总结

This study aims to assess the effectiveness (specificity and sensitivity) of using magnetic resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in patients with Crohns disease. Patients with evidence of axSpA on MRE imaging will be assessed clinically for axSpA (including a dedicated axial magnetic resonance imaging scan of the spine and sacroiliac joints) and will be compared to a group of age and sex-matched control participants with Crohn's disease but with no evidence of axSpA on MRE imaging.

详细描述

Spondyloarthritis (SpA) is a term that encompasses psoriatic arthritis with axial disease, ankylosing spondylitis and non-radiological axial spondyloarthritis. The prevalence of SpA in the general population is estimated to be between 0.01%-2.5%. SpA patients have a high burden of inflammatory bowel disease (IBD), which primarily includes Crohn's disease (CD) and Ulcerative colitis (UC), with an estimated prevalence of 10%-12%. However, few studies have investigated the converse; the presence of IBD cases with undiagnosed SpA. Untreated SpA may lead to a significant impact on general health and quality of life; therefore early diagnosis and treatment is crucial. Most CD patients will have had a MRE assessment for their CD, which also captures the axial skeleton and can therefore be used to screen for evidence of axial SpA (axSpA). In this study, MRE images from consenting CD subjects will be reviewed for evidence of axSpA. CD patients with evidence of axSpA will then be reviewed in a rheumatology clinic to assess more specifically for SpA. This will include completion of patient reported outcome measures, clinical examination, routine blood tests, human leucocyte antigen (HLA)-B27 genotyping and a dedicated axial magnetic resonance imaging (MRI) scan. The patients will also be consented to participate in the second part of the study which will be to compare these 'cases' statistically to a 'control' group of age- and sex-matched CD subjects without MRE evidence of axSpA.

This study aims to: (i) determine the validity, sensitivity and specificity of MRE as a screening tool for axSpA in CD patients using dedicated axial MRI scans with clinical assessment as the gold standard; (ii) devise an algorithm of clinical indices that can be used as a screening tool for axSpA in CD cases.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Subjects who are willing and able to give informed consent for participation in the study.
  • Male and female subjects aged 18 years or above.
  • Diagnosed by the gastroenterology team with Crohn's disease.
  • MRE imaging since 2015 for their Crohn's disease.

排除标准

  • Subjects unwilling or unable to give informed consent.

结局指标

主要结局

The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease

时间窗: 12 months

We assessed the SIJs on MRE imaging of patients with Crohn's disease (CD) for abnormalities potentially consistent with axial spondyloarthritis (axSpA), using a novel SIJ scoring system of 0-10 (0 = normal SIJs, 1-10 = abnormal SIJs). These patients were then assessed for evidence of axSpA using the Assessment of Spondyloarthritis International Society (ASAS) classification criteria for axSpA, including a dedicated axial MRI of the spine and pelvis. This primary outcome measure assessed the true positive rate (sensitivity) and true negative rate (specificity) of using MRE imaging of patients with CD to identify axSpA. A receiver operating characteristic (ROC) curve was generated using the novel SIJ scoring system of 0-10 and a 'diagnosis of axSpA' or 'no diagnosis of axSpA'. The ROC curve illustrated the true positive rate and true negative rate of using MRE as a screening tool for axSpA for each unit score (0-10) of the SIJ scoring system. This was performed using Stata 16 (2019).

次要结局

  • The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the 2009 ASAS Criteria for Axial Spondyloarthritis.(12 months)
  • The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the Modified New York Criteria for Ankylosing Spondylitis(12 months)
  • The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the CASPAR Criteria for Psoriatic Arthritis(12 months)
  • The Number (and Percentage) of Participants Fulfilling the 2009 ASAS Criteria for axSpA Proceeding to Non-pharmacological and Pharmacological Treatment of Their axSpA, as a Surrogate Measure of Change in Clinical Care as a Result of MRE Screening.(12 months)
  • The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease(12 months)
  • The Predictive Value of a Particular Site of Crohn's Disease (Colon, Ileum Etc) With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease(12 months)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jobie Evans

Dr Jobie Evans (MD Student)

Cambridge University Hospitals NHS Foundation Trust

研究点 (1)

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