SpondyloarthropathySpACENCT03064815
The SpACE Study - Small Bowel Crohn's Disease and Spondyloarthropathies
A study testing Videocapsule endoscopy, colonoscopy and PROMETHEUS® IBD sgi Diagnostic™ in people with Spondyloarthropathy and Crohn Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Spondyloarthropathy, Crohn Disease
- What is being tested?
- Videocapsule endoscopy, colonoscopy and PROMETHEUS® IBD sgi Diagnostic™
- Type of treatment
- Pill or oral medicine, Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2009to Mar 2016
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Consenting patients with spondylarthropathies or ankolysiing spondylitis, according to European Ppondyloarthropathy Study Group criteria or New York Criteria:
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prevalence of Small Bowel Inflammatory Crohn's Disease Lesions in Patients With Spondyloarthropathies (SpA): A Prospective Capsule Endoscopy-Based Study
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.
Read the 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.
- Conditions
- Spondyloarthropathy, Crohn Disease
- Being tested
- Videocapsule endoscopy, colonoscopy, PROMETHEUS® IBD sgi Diagnostic™, Fecal calprotectin
- Medical subject headings
- Spondylarthropathies, Crohn Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Videocapsule endoscopyDevice
Also called Capsule 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.
colonoscopyProcedure or surgery
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.
PROMETHEUS® IBD sgi Diagnostic™Diagnostic test
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.
Fecal calprotectinDiagnostic test
A stool test to measure inflammation in the gut.
| Study group | Role | What they receive |
|---|---|---|
| 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) Receives: Device: Videocapsule endoscopy; Procedure: colonoscopy; Diagnostic Test: PROMETHEUS® IBD sgi Diagnostic™; Diagnostic Test: Fecal calprotectin |
| 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) Receives: Device: Videocapsule endoscopy; Procedure: colonoscopy; Diagnostic Test: PROMETHEUS® IBD sgi Diagnostic™; Diagnostic Test: Fecal calprotectin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Determine how accurate capsule endoscopy is in diagnosing small bowel crohn's disease in patients with ankolysing spondylitis.as compared to serology, fecal biomarkers and serological tests
Measured: 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.
Evaluate whether the capsule findings alter or impact management of ankolysing spondylitis patients with small bowel Crohn's disease.
Measured: 2 years
Determine whether genetic polymorphisms or human leukocyte antigen haplotypes are associated with concurrent spondylarthropathies and inflammatory bowel disease.
Genetic analysis
Measured: 1 yr post sample collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2017
- Study startJun 2009
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SpondyloarthropathyStudies of the same condition, open and under way.
- More trials run by McGill University Health Centre/Research Institute of the McGill University Health CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health Centre
- Sponsor type
- University, hospital or other
- Collaborators
- AbbVie, Prometheus Laboratories
- Responsible party
- Principal investigator, Ernest Seidman, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Ernest Seidman, MD, Principal investigator, Research Institute of the MUHCMichael Starr, MD, Principal investigator, Research Institute of the MUHC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064815
- Sponsor's protocol ID
- GEN-08-053
- Acronym
- SpACE
- Status last verified
- Aug 2019
- First submitted
- 10 Feb 2017
- Last updated
- 19 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of Small Bowel Inflammatory Crohn's Disease Lesions in Patients With Spondyloarthropathies (SpA): A Prospective Capsule Endoscopy-Based Study
- ClinicalTrials.gov ID
- NCT03064815
- Acronym / sponsor ID
- SpACE / GEN-08-053
- Conditions
- Spondyloarthropathy, Crohn Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- McGill University Health Centre/Research Institute of the McGill University Health CentreUniversity, hospital or other
- Collaborators
- AbbVie, Prometheus Laboratories
- Study start
- Jun 2009
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 27 Feb 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Spondylarthropathies with GI symptoms | Experimental | Device: Videocapsule endoscopy, Procedure: colonoscopy, Diagnostic Test: PROMETHEUS® IBD sgi Diagnostic™, Diagnostic Test: Fecal calprotectinSubjects 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 | Experimental | Device: Videocapsule endoscopy, Procedure: colonoscopy, Diagnostic Test: PROMETHEUS® IBD sgi Diagnostic™, Diagnostic Test: Fecal calprotectinSubjects 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) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Consenting patients with spondylarthropathies or ankolysiing spondylitis, according to European Ppondyloarthropathy Study Group criteria or New York Criteria:
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Videocapsule endoscopyAlso: Capsule endoscopyCapsule 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. | Device | Spondylarthropathies with GI symptoms, Spondylarthropathies without GI symptoms |
| colonoscopyColonoscopy 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. | Procedure or surgery | Spondylarthropathies with GI symptoms, Spondylarthropathies without GI symptoms |
| 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 | Spondylarthropathies with GI symptoms, Spondylarthropathies without GI symptoms |
| Fecal calprotectinA stool test to measure inflammation in the gut. | Diagnostic test | Spondylarthropathies with GI symptoms, Spondylarthropathies without GI symptoms |
Primary outcome
Number of subjects with ankolysing spondylitis, with or without gastrointestinal symptoms, diagnosed with small bowel Crohn's disease via videocapsule endoscopy.
Time frame: 2 years
Accuracy of diagnosing small bowel Crohn's disease in patients with ankolysing spondylitis.
3 secondary outcomes
Number of subjects with ankolysing spondylitis diagnosed with small bowel Crohn's disease compared to same subjects serological biomarkers and colonoscopy results.
Time frame: 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.
Time frame: 2 years
Determine whether genetic polymorphisms or human leukocyte antigen haplotypes are associated with concurrent spondylarthropathies and inflammatory bowel disease.
Time frame: 1 yr post sample collection
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2019.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ernest Seidman, MD principal investigator
Research Institute of the MUHC
Michael Starr, MD principal investigator
Research Institute of the MUHC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Videocapsule endoscopy, colonoscopy and PROMETHEUS® IBD sgi Diagnostic™ in people with Spondyloarthropathy and Crohn Disease, run by McGill University Health Centre/Research Institute of the McGill University Health Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of subjects with ankolysing spondylitis, with or without gastrointestinal symptoms, diagnosed with small bowel Crohn's disease via videocapsule endoscopy. (time frame: 2 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2019.