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临床试验/NCT05203926
NCT05203926已完成不适用

Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study

NYU Langone Health1 个研究点 分布在 1 个国家目标入组 27 人开始时间: 2022年3月14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
27
试验地点
1
主要终点
Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)

研究概览

简要总结

This study aims to further define and characterize imaging findings of possible sacroiliitis in Crohn's Disease patients by recalling subjects who had findings of possible sacroiliitis on prior MRE and assess the natural history and outcome of these cases by using standard magnetic resonance imaging (MRI) and x-ray of the sacroiliac joints.

详细描述

When axial spondyloarthritis (SpA) occurs in Crohn's disease (CD) is an important clinical and research question that has not been fully answered. Magnetic resonance enterography (MRE), routinely obtained in Crohn's disease (CD) patients, can be utilized to assess sacroiliac joints (SIJ); currently published literature shows that it could be a valuable tool to detect active inflammation of sacroiliitis in CD patients. Only a small fraction of CD patients with MRE evidence of sacroiliitis is referred to rheumatologists for further evaluation. The proposed project aims to further define MRE features of sacroiliitis in CD by recalling subjects who had prior positive findings and assess the natural history and outcome of these cases by standard magnetic resonance imaging (MRI) of sacroiliac joints and SIJ X-ray. 37 CD subjects who were already found to have sacroiliitis in the previous MRE study will be recalled. Subjects will undergo standard MRI of SIJ, plain X-ray of SIJ and the rheumatologist will obtain detailed history and examine patients for evaluation of possible axial SpA. Other details pertaining to CD, CD therapy and activity, will also be obtained to help clarify a correlation between CD and axial SpA. This pilot study will allow better characterization of imaging features of sacroiliitis on MRE, provide useful information on clinical significance of these lesions in CD patients, and potentially establish MRE as a screening tool for early detection of sacroiliitis in CD patients.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 100 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Evidence of sacroiliitis on earlier standard of care MRE between 2014 and
  • Confirmed diagnosis of Crohn's Disease
  • Known HLA-B27 status at time of enrollment and most recent clinical ESR and CRP results from chart (from day of visit or within past 4 weeks of study visit)
  • Adults >18 years of age

排除标准

  • History of other inflammatory arthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout).
  • Contraindication to MRI.
  • History of malignancy <5 years in remission, (except for non-melanomatous skin cancer).
  • Inability to comply with study protocol.
  • Critically ill patients.
  • Pregnant patients.
  • Non-English speaking patients (as the questionnaires used in this study are not validated in other languages)

结局指标

主要结局

Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)

时间窗: Intervention Visit 1 (Day 1)

The MRI scans will establish significance of sacroiliitis features/lesions seen on MRE.

次要结局

  • Measurement of Ankylosing Spondylitis Disease Activity(Intervention Visit 1 (Day 1))
  • Measurement of CDAI- Crohn's Disease Activity Index(Intervention Visit 1 (Day 1))
  • Measurement of Bath Ankylosing Spondylitis Functional Index(Intervention Visit 1 (Day 1))
  • Measurement of Bath Ankylosing Spondylitis Disease Activity Index(Intervention Visit 1 (Day 1))
  • Measurement of HBI- Harvey-Bradshaw Index(Intervention Visit 1 (Day 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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