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MRE as a Screening Tool for axSpA in IBD (ProSpA-CD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03817983
Recruitment Status : Completed
First Posted : January 28, 2019
Last Update Posted : March 15, 2022
Sponsor:
Collaborator:
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
Jobie Evans, Cambridge University Hospitals NHS Foundation Trust

Study Description
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Brief Summary:
This study aims to assess the effectiveness (specificity and sensitivity) of using magnetic resonance enterography (MRE) as a screening tool for axial spondyloarthritis (axSpA) in patients with Crohns disease. Patients with evidence of axSpA on MRE imaging will be assessed clinically for axSpA (including a dedicated axial magnetic resonance imaging scan of the spine and sacroiliac joints) and will be compared to a group of age and sex-matched control participants with Crohn's disease but with no evidence of axSpA on MRE imaging.

Condition or disease Intervention/treatment
Axial Spondyloarthritis Crohn Disease Diagnostic Test: MRE review for axSpA

Detailed Description:

Spondyloarthritis (SpA) is a term that encompasses psoriatic arthritis with axial disease, ankylosing spondylitis and non-radiological axial spondyloarthritis. The prevalence of SpA in the general population is estimated to be between 0.01%-2.5%. SpA patients have a high burden of inflammatory bowel disease (IBD), which primarily includes Crohn's disease (CD) and Ulcerative colitis (UC), with an estimated prevalence of 10%-12%. However, few studies have investigated the converse; the presence of IBD cases with undiagnosed SpA. Untreated SpA may lead to a significant impact on general health and quality of life; therefore early diagnosis and treatment is crucial. Most CD patients will have had a MRE assessment for their CD, which also captures the axial skeleton and can therefore be used to screen for evidence of axial SpA (axSpA). In this study, MRE images from consenting CD subjects will be reviewed for evidence of axSpA. CD patients with evidence of axSpA will then be reviewed in a rheumatology clinic to assess more specifically for SpA. This will include completion of patient reported outcome measures, clinical examination, routine blood tests, HLA-B27 genotyping and a dedicated axial magnetic resonance imaging (MRI) scan. The patients will also be consented to participate in the second part of the study which will be to compare these 'cases' statistically to a 'control' group of age- and sex-matched CD subjects without MRE evidence of axSpA.

This study aims to: (i) determine the validity, sensitivity and specificity of MRE as a screening tool for axSpA in CD patients using dedicated axial MRI scans with clinical assessment as the gold standard; (ii) devise an algorithm of clinical indices that can be used as a screening tool for axSpA in CD cases.

Study Design
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Study Type : Observational
Actual Enrollment : 261 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: Magnetic Resonance Enterography as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease: A Prospective Single-center Cross-sectional Observational Study Using MRE Screening Followed by Clinical Assessment
Actual Study Start Date : March 4, 2019
Actual Primary Completion Date : August 8, 2020
Actual Study Completion Date : August 8, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Groups and Cohorts
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Group/Cohort Intervention/treatment
MRE review for axSpA
Review of MRE scan for evidence of axSpA in Crohn's disease patients
 Diagnostic Test: MRE review for axSpA
Screening for evidence of axSpA on the MRE scan of patients with Crohn's disease followed by clinical and MRI assessment


Outcome Measures
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Primary Outcome Measures :
  1. The sensitivity and specificity of MRE as a screening tool for axial spondyloarthritis in Crohn's disease [ Time Frame: 12 months ]

Secondary Outcome Measures :
  1. The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the 2009 ASAS criteria for axial Spondyloarthritis. [ Time Frame: 12 months ]
    ASAS (Assessment of Spondyloarthritis International Society)

  2. The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the modified New York criteria for Ankylosing spondylitis [ Time Frame: 12 months ]
  3. The proportion of patients (percentage) with evidence of axial Spondyloarthritis on MRE imaging who fulfill the CASPAR criteria for psoriatic arthritis [ Time Frame: 12 months ]
    CASPAR (Classification Criteria for Psoriatic Arthritis)

  4. The proportion of these patients (expressed as a percentage) proceeding to non-pharmacological and pharmacological treatment of their axial Spondyloarthritis, as a surrogate measure of change in clinical care as a result of MRE screening. [ Time Frame: 12 months ]
  5. The predictive value of specific extra-articular features with a diagnosis of axial spondyloarthritis in Crohn's disease [ Time Frame: 12 months ]
  6. The predictive value of a particular site of Crohn's disease (colon, ileum etc) with a diagnosis of axial spondyloarthritis in Crohn's disease [ Time Frame: 12 months ]

Biospecimen Retention:   Samples With DNA
All subjects (cases and controls) will be asked to consent to provide research samples, including whole blood and stool, for storage and future analysis (serum for biomarker analysis, plasma for proteomic analysis, DNA for genotyping, and stool for microbiome analysis).

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Patients with Crohn's disease (aged more than 18 years) who have had a MRE scan performed between January 1st 2015 and January 1st 2019
Criteria

Inclusion Criteria:

  1. Subjects who are willing and able to give informed consent for participation in the study.
  2. Male and female subjects aged 18 years or above.
  3. Diagnosed by the gastroenterology team with Crohn's disease.
  4. MRE imaging since 2015 for their Crohn's disease.

Exclusion Criteria:

1. Subjects unwilling or unable to give informed consent.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03817983


Locations
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United Kingdom
Rheumatology Research Unit
Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ
Sponsors and Collaborators
Cambridge University Hospitals NHS Foundation Trust
Merck Sharp & Dohme LLC
Investigators
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Principal Investigator: Deepak R Jadon, MBBCh PhD CUH NHSFT
More Information
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Responsible Party: Jobie Evans, Dr Jobie Evans (MD Student), Cambridge University Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03817983    
Other Study ID Numbers: A094864
First Posted: January 28, 2019    Key Record Dates
Last Update Posted: March 15, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spondylitis
Spondylarthritis
Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases
 Bone Diseases, Infectious
Infections
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Arthritis
Joint Diseases