MRE as a Screening Tool for axSpA in IBD (ProSpA-CD)
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|ClinicalTrials.gov Identifier: NCT03817983|
Recruitment Status : Completed
First Posted : January 28, 2019
Last Update Posted : March 15, 2022
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|Condition or disease||Intervention/treatment|
|Axial Spondyloarthritis Crohn Disease||Diagnostic Test: MRE review for axSpA|
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 Type :||Observational|
|Actual Enrollment :||261 participants|
|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|
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
- The sensitivity and specificity of MRE as a screening tool for axial spondyloarthritis in Crohn's disease [ Time Frame: 12 months ]
- 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)
- 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 ]
- 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)
- 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 ]
- The predictive value of specific extra-articular features with a diagnosis of axial spondyloarthritis in Crohn's disease [ Time Frame: 12 months ]
- 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
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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|
- Subjects who are willing and able to give informed consent for participation in the study.
- Male and female subjects aged 18 years or above.
- Diagnosed by the gastroenterology team with Crohn's disease.
- MRE imaging since 2015 for their Crohn's disease.
1. Subjects unwilling or unable to give informed consent.
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
|Rheumatology Research Unit|
|Cambridge, Cambridgeshire, United Kingdom, CB2 0QQ|
|Principal Investigator:||Deepak R Jadon, MBBCh PhD||CUH NHSFT|
|Responsible Party:||Jobie Evans, Dr Jobie Evans (MD Student), Cambridge University Hospitals NHS Foundation Trust|
|Other Study ID Numbers:||
|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|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Inflammatory Bowel Diseases
Digestive System Diseases
Bone Diseases, Infectious