The SpACE Study - Small Bowel Crohn's Disease and Spondyloarthropathies
SpACE
Prevalence of Small Bowel Inflammatory Crohn's Disease Lesions in Patients With Spondyloarthropathies (SpA): A Prospective Capsule Endoscopy-Based Study
1 other identifier
interventional
67
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jun 2009
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 10, 2017
CompletedFirst Posted
Study publicly available on registry
February 27, 2017
CompletedAugust 19, 2019
August 1, 2019
6.8 years
February 10, 2017
August 14, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Number of subjects with ankolysing spondylitis, with or without gastrointestinal symptoms, diagnosed with small bowel Crohn's disease via videocapsule endoscopy.
Accuracy of diagnosing small bowel Crohn's disease in patients with ankolysing spondylitis.
2 years
Secondary Outcomes (3)
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
Determine whether genetic polymorphisms or human leukocyte antigen haplotypes are associated with concurrent spondylarthropathies and inflammatory bowel disease.
1 yr post sample collection
Study Arms (2)
Spondylarthropathies with GI symptoms
EXPERIMENTALSubjects 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)
Spondylarthropathies without GI symptoms
EXPERIMENTALSubjects 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)
Interventions
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.
Eligibility Criteria
You may qualify if:
- Consenting patients with spondylarthropathies or ankolysiing spondylitis, according to European Ppondyloarthropathy Study Group criteria or New York Criteria:
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Montreal General Hospital
Montreal, Quebec, H3G 1A4, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ernest Seidman, MD
Research Institute of the MUHC
- PRINCIPAL INVESTIGATOR
Michael Starr, MD
Research Institute of the MUHC
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Director of Research in IBD at McGill University
Study Record Dates
First Submitted
February 10, 2017
First Posted
February 27, 2017
Study Start
June 1, 2009
Primary Completion
March 1, 2016
Study Completion
March 1, 2016
Last Updated
August 19, 2019
Record last verified: 2019-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, CSR
- Time Frame
- As data is compiled and assessed it will be shared via abstracts, presentations and manuscripts.
Patients will be told of the results of all blood work and diagnostic tests. Data will be presented at scientific conferences as well as published in scientific journals.