The SpACE Study - Small Bowel Crohn's Disease and Spondyloarthropathies

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.

Conditions

• Spondyloarthropathy
• Crohn Disease

Interventions

DEVICE

Videocapsule endoscopy

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.

PROCEDURE

colonoscopy

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.

DIAGNOSTIC_TEST

PROMETHEUS® IBD sgi Diagnostic™

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.

DIAGNOSTIC_TEST

Fecal calprotectin

A stool test to measure inflammation in the gut.

Sponsors & Collaborators

• AbbVie

  collaborator INDUSTRY

• Prometheus Laboratories

  collaborator INDUSTRY

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

  lead OTHER

Principal Investigators

• Ernest Seidman, MD · Research Institute of the MUHC

• Michael Starr, MD · Research Institute of the MUHC

Study Design

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2009-06-30

Primary Completion

2016-03-31

Completion

2016-03-31

Countries

• Canada

Study Locations