N/A N=259

MRE as a Screening Tool for axSpA in IBD

Axial Spondyloarthritis · Crohn Disease

Bottom Line

View on ClinicalTrials.gov: NCT03817983 ↗

Enrolled (actual)

259

Serious AEs

0.0%

Results posted

Jan 2025

Primary outcome: Primary: The Sensitivity and Specificity of MRE as a Screening Tool for Axial Spondyloarthritis in Crohn's Disease — 0.88; 0.50; 0.78 Probability

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: MRE review for evidence of axSpA in SIJs (Diagnostic_test); Clinical assessment and dedicated MRI of the spine and pelvis (Diagnostic_test)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Cambridge University Hospitals NHS Foundation Trust
Primary completion: Aug 2020

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	—

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.

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.

View full record on ClinicalTrials.gov →

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.