Clinical trial NCT05203926: Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study
Official title: Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliitis
Lead sponsor: NYU Langone Health
Sponsor class: OTHER
Collaborators: name: Spondyloarthritis Research and Treatment Network
First posted: 2022-01-24
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: This study aims to further define and characterize imaging findings of possible sacroiliitis in Crohn's Disease patients by recalling subjects who had findings of possible sacroiliitis on prior MRE and assess the natural history and outcome of these cases by using standard magnetic resonance imaging (MRI) and x-ray of the sacroiliac joints.

Detailed description: When axial spondyloarthritis (SpA) occurs in Crohn's disease (CD) is an important clinical and research question that has not been fully answered. Magnetic resonance enterography (MRE), routinely obtained in Crohn's disease (CD) patients, can be utilized to assess sacroiliac joints (SIJ); currently published literature shows that it could be a valuable tool to detect active inflammation of sacroiliitis in CD patients. Only a small fraction of CD patients with MRE evidence of sacroiliitis is referred to rheumatologists for further evaluation. The proposed project aims to further define MRE features of sacroiliitis in CD by recalling subjects who had prior positive findings and assess the natural history and outcome of these cases by standard magnetic resonance imaging (MRI) of sacroiliac joints and SIJ X-ray. 37 CD subjects who were already found to have sacroiliitis in the previous MRE study will be recalled. Subjects will undergo standard MRI of SIJ, plain X-ray of SIJ and the rheumatologist will obtain detailed history and examine patients for evaluation of possible axial SpA. Other details pertaining to CD, CD therapy and activity, will also be obtained to help clarify a correlation between CD and axial SpA. This pilot study will allow better characterization of imaging features of sacroiliitis on MRE, provide useful information on clinical significance of these lesions in CD patients, and potentially establish MRE as a screening tool for early detection of sacroiliitis in CD patients.

Eligibility criteria: Inclusion Criteria:

* Evidence of sacroiliitis on earlier standard of care MRE between 2014 and 2018.
* Confirmed diagnosis of Crohn's Disease
* Known HLA-B27 status at time of enrollment and most recent clinical ESR and CRP results from chart (from day of visit or within past 4 weeks of study visit)
* Adults \>18 years of age

Exclusion Criteria:

* History of other inflammatory arthritis (e.g. rheumatoid arthritis, systemic lupus erythematosus, gout).
* Contraindication to MRI.
* History of malignancy \<5 years in remission, (except for non-melanomatous skin cancer).
* Inability to comply with study protocol.
* Critically ill patients.
* Pregnant patients.
* Non-English speaking patients (as the questionnaires used in this study are not validated in other languages)

Primary outcomes:
measure: Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)
timeFrame: Intervention Visit 1 (Day 1)
measure: Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)
timeFrame: Intervention Visit 1 (Day 1)
Secondary outcomes:
measure: Measurement of Ankylosing Spondylitis Disease Activity
timeFrame: Intervention Visit 1 (Day 1)
measure: Measurement of Bath Ankylosing Spondylitis Disease Activity Index
timeFrame: Intervention Visit 1 (Day 1)
measure: Measurement of Bath Ankylosing Spondylitis Functional Index
timeFrame: Intervention Visit 1 (Day 1)
measure: Measurement of HBI- Harvey-Bradshaw Index
timeFrame: Intervention Visit 1 (Day 1)
measure: Measurement of CDAI- Crohn's Disease Activity Index
timeFrame: Intervention Visit 1 (Day 1)
Other outcomes:
Locations:
city: New York
country: United States
facility: NYU Langone Health
state: New York
Study officials:
affiliation: NYU Langone Health
name: Fardina Malik, MD
role: PRINCIPAL_INVESTIGATOR
References: