The SpACE Study - Small Bowel Crohn's Disease and Spondyloarthropathies
Condition: Spondyloarthropathy; Crohn Disease
MeSH terms: Spondylitis; Spondylarthropathies; Spondylarthritis; Crohn Disease
Study type: Interventional

Summary: 
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Videocapsule endoscopy; colonoscopy; PROMETHEUS® IBD sgi Diagnostic™; Fecal calprotectin
Intervention type(s): Device; Procedure; Diagnostic Test; Diagnostic Test
Intervention description(s): Capsule endoscopy is a procedure that uses a tiny wireless camera to take pictures of your digestive tract. A capsule endoscopy camera sits inside a vitamin-size capsule you swallow. As the capsule travels through your digestive tract, the camera takes thousands of pictures that are transmitted to a recorder you wear on a belt around your waist.
Capsule endoscopy helps doctors see inside your small intestine - an area that isn't easily reached with more-traditional endoscopy procedures.; Colonoscopy is a test that allows your doctor to look at the inner lining of your large intestine (rectum and colon). He or she uses a thin, flexible tube called a colonoscope to look at the colon.; This test combines serologic, genetic, and inflammation markers in a proprietary Smart Diagnostic Algorithm to provide added IBD diagnostic clarity. This test helps physicians differentiate IBD vs. non-IBD and CD vs. UC in one comprehensive blood test.; A stool test to measure inflammation in the gut.
Other intervention name(s): Capsule endoscopy
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Diagnostic