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临床试验/NCT03064815
NCT03064815已完成不适用

Prevalence of Small Bowel Inflammatory Crohn's Disease Lesions in Patients With Spondyloarthropathies (SpA): A Prospective Capsule Endoscopy-Based Study

McGill University Health Centre/Research Institute of the McGill University Health Centre2 个研究点 分布在 1 个国家目标入组 67 人开始时间: 2009年6月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
67
试验地点
2
主要终点
Number of subjects with ankolysing spondylitis, with or without gastrointestinal symptoms, diagnosed with small bowel Crohn's disease via videocapsule endoscopy.

研究概览

简要总结

Inflammatory bowel disease is clinically associated with spondylarthropathies in 5-15% of cases. Protocol colonoscopic assessment demonstrated asymptomatic inflammation characteristic of Crohn's disease in up to 1/3 of SpA patients. Videocapsule endoscopy is a superior diagnostic tool to detect small bowel mucosal pathology. However, it has been infrequently used to evaluate bowel inflammation in spondylarthropathies. This study compared the accuracy of videocapsule endoscopy to standard ileocolonoscopy for the detection of inflammatory bowel lesions in patients with spondylarthropathies, and to describe the clinical and laboratory predictors of small bowel inflammation in this cohort.

详细描述

The link between chronic inflammatory bowel disease and arthritis is well established. IBD is associated with 3 patterns of arthritis (1), one of which is spondylarthropathy (2). spondylarthropathies is not uncommon, with 3-6% of patients with IBD affected, while radiologic sacroileitis is evident in up to 18% of patients. SpA associated with IBD differs from that of idiopathic ankylosing spondylitis in that the prevalence of HLA-B27, although high (20-40%), is significantly lower than in typical AS, where its prevalence is characteristically 90%. Both inflammatory bowel disease and spondylarthropathies show familial clustering and may coexist. Idiopathic ankolysing spondylitis and ankolysing spondylitis usually occurs without overt signs of intestinal inflammation. However, ileocolonoscopy studies have shown a high prevalence (30-44%) of asymptomatic inflammation of the terminal ileum. The nature of this inflammation is highly characteristic of Crohn's disease. Among spondyloarthropathies patients with subclinical inflammation, only 6% were reported to eventually develop clinically apparent inflammatory bowel disease. A more recent review of endoscopy-based studies detected Crohn's disease more frequently, in 18-48 % of patients with spondyloarthropathies and in 5-11% of ankolysing spondylitis.. However, conventional endoscopic and radiological techniques are limited in their capacity to investigate the entire small bowel, and could easily miss significant mucosal lesions due to Crohn's disease.

Capsule endoscopy has been shown to be superior to conventional diagnostic techniques for the investigation of suspected Crohn's disease. The primary objective of this study is to demonstrate that this safe, non-invasive technique will reveal unidentified small bowel lesions in asymptomatic subjects with spondylarthropathies or ankolysing spondylitis more reliably than ileo-colonoscopy with biopsies.

Clinical implications: Spondylarthropathies, ankolysing spondylitis and inflammatory bowel disease are clinically, genetically and pathologically linked. Anti-tumor necrosis factor agents, including Adalimumab, Etanercept and Infliximab, are all efficacious and cost-effective in treating spondylarthropathies and ankolysing spondylitis. Since only some anti-TNF molecules are highly effective for both Crohn's disease and spondylarthropathies and related arthropathies, the present study ideally would lead to a change in general therapeutic practice, leading to wider use of molecules with a wide scope of therapeutic success.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Consenting patients with spondylarthropathies or ankolysiing spondylitis, according to European Ppondyloarthropathy Study Group criteria or New York Criteria:

排除标准

  • Patients having been or are currently exposed to an anti-tumour necrotic factor treatment (Adalimumab or Infliximab). Patients treated with anti-tumour necrotic factor receptor antibodies (Etanercept) are not excluded.

研究组 & 干预措施

Spondylarthropathies with GI symptoms

Experimental

Subjects in this arm will have spondylarthropathies and gastrointestinal symptoms and will undergo a colonoscopy, videocapsule endoscopy, biomarker testing (PROMETHEUS® IBD sgi Diagnostic™ and fecal calprotectin)

干预措施: Videocapsule endoscopy (Device)

Spondylarthropathies with GI symptoms

Experimental

Subjects in this arm will have spondylarthropathies and gastrointestinal symptoms and will undergo a colonoscopy, videocapsule endoscopy, biomarker testing (PROMETHEUS® IBD sgi Diagnostic™ and fecal calprotectin)

干预措施: colonoscopy (Procedure)

Spondylarthropathies with GI symptoms

Experimental

Subjects in this arm will have spondylarthropathies and gastrointestinal symptoms and will undergo a colonoscopy, videocapsule endoscopy, biomarker testing (PROMETHEUS® IBD sgi Diagnostic™ and fecal calprotectin)

干预措施: PROMETHEUS® IBD sgi Diagnostic™ (Diagnostic Test)

Spondylarthropathies with GI symptoms

Experimental

Subjects in this arm will have spondylarthropathies and gastrointestinal symptoms and will undergo a colonoscopy, videocapsule endoscopy, biomarker testing (PROMETHEUS® IBD sgi Diagnostic™ and fecal calprotectin)

干预措施: Fecal calprotectin (Diagnostic Test)

Spondylarthropathies without GI symptoms

Experimental

Subjects in this arm will have spondylarthropathies without gastrointestinal symptoms and will undergo a colonoscopy, videocapsule endoscopy, biomarker testing (PROMETHEUS® IBD sgi Diagnostic™ and fecal calprotectin)

干预措施: Videocapsule endoscopy (Device)

Spondylarthropathies without GI symptoms

Experimental

Subjects in this arm will have spondylarthropathies without gastrointestinal symptoms and will undergo a colonoscopy, videocapsule endoscopy, biomarker testing (PROMETHEUS® IBD sgi Diagnostic™ and fecal calprotectin)

干预措施: colonoscopy (Procedure)

Spondylarthropathies without GI symptoms

Experimental

Subjects in this arm will have spondylarthropathies without gastrointestinal symptoms and will undergo a colonoscopy, videocapsule endoscopy, biomarker testing (PROMETHEUS® IBD sgi Diagnostic™ and fecal calprotectin)

干预措施: PROMETHEUS® IBD sgi Diagnostic™ (Diagnostic Test)

Spondylarthropathies without GI symptoms

Experimental

Subjects in this arm will have spondylarthropathies without gastrointestinal symptoms and will undergo a colonoscopy, videocapsule endoscopy, biomarker testing (PROMETHEUS® IBD sgi Diagnostic™ and fecal calprotectin)

干预措施: Fecal calprotectin (Diagnostic Test)

结局指标

主要结局

Number of subjects with ankolysing spondylitis, with or without gastrointestinal symptoms, diagnosed with small bowel Crohn's disease via videocapsule endoscopy.

时间窗: 2 years

Accuracy of diagnosing small bowel Crohn's disease in patients with ankolysing spondylitis.

次要结局

  • Determine whether genetic polymorphisms or human leukocyte antigen haplotypes are associated with concurrent spondylarthropathies and inflammatory bowel disease.(1 yr post sample collection)
  • Number of subjects with ankolysing spondylitis diagnosed with small bowel Crohn's disease compared to same subjects serological biomarkers and colonoscopy results.(2 years)
  • Number of subjects with ankolysing spondylitis diagnosed with small bowel Crohn's disease whose treatment changed as a result of the diagnosis of small bowel Crohn's disease.(2 years)

研究者

发起方
McGill University Health Centre/Research Institute of the McGill University Health Centre
申办方类型
Other
责任方
Principal Investigator
主要研究者

Ernest Seidman

Director of Research in IBD at McGill University

McGill University Health Centre/Research Institute of the McGill University Health Centre

研究点 (2)

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