N/A
Completed N=259
MRE as a Screening Tool for axSpA in IBD
Source: ClinicalTrials.gov NCT03817983 ↗Enrolled (actual)
259
Serious AEs
0.0%
Results posted
Jan 2025
Primary outcomePrimary: The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease — 0.88; 0.50; 0.78 Probability
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease |
0.88; 0.50; 0.78 | — |
| SECONDARY The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the 2009 ASAS Criteria for Axial Spondyloarthritis. |
22 | — |
| SECONDARY The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the Modified New York Criteria for Ankylosing Spondylitis |
8 | — |
| SECONDARY The Number (and Percentage) of Participants With Evidence of Axial Spondyloarthritis on MRE Imaging Who Fulfill the CASPAR Criteria for Psoriatic Arthritis |
8 | — |
| SECONDARY The Number (and Percentage) of Participants Fulfilling the 2009 ASAS Criteria for axSpA Proceeding to Non-pharmacological and Pharmacological Treatment of Their axSpA, as a Surrogate Measure of Change in Clinical Care as a Result of MRE Screening. |
4; 5; 12; 1 | — |
| SECONDARY The Predictive Value of Specific Extra-articular Features With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease |
4.71; 3.71; 1.29; 1.57 | — |
| SECONDARY The Predictive Value of a Particular Site of Crohn's Disease (Colon, Ileum Etc) With a Diagnosis of Axial Spondyloarthritis in Crohn's Disease |
1.01; 1.38; 0.86 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
- Subjects unwilling or unable to give informed consent.
Data sourced from ClinicalTrials.gov (NCT03817983). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.