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Imaging Biomarkers in Crohn's Associated Spondyloarthritis

NCT02709694 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 33

Last updated 2021-10-25

Study results available
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Summary

In patients with Crohn's Disease, symptoms of inflammatory back pain (IBP) precede changes on plain X-rays by years, and MRI changes of axial inflammation precede development of X-ray changes. Sacroiliitis on MRI without x-ray changes (i.e.Non radiographic SpA) is a valid diagnostic criterion for Spondyloarthritis (SpA) and leads to earlier diagnosis of SpA in patients with IBP. It is unclear when MRI changes occur, and if they precede clinical symptoms of IBP. There are reports of asymptomatic sacroiliitis noted on MRI in Crohn's patients. This is important, as MRI evidence of inflammation may be the first sign of incipient SpA. Inflammation in other regions of the axial skeleton in SpA patients has also been documented, but its significance is unknown. The prospect of undiagnosed and untreated inflammation is concerning, as it can lead to significant morbidity. Moreover, relationship between MRI evidence of axial inflammation-likely a proxy for systemic inflammation- and patient reported outcomes (e.g. ASDAS-CRP= Ankylosing Spondylitis Disease Activity Score- C reactive protein, BASDAI= Bath Ankylosing Spondylitis Disease Activity Index, SF-12 = Short Form- 12, HBI= Hervey Bradshaw Index and PROMIS-29= Patient Reported Outcome Measurement Information System-29), has not been reported. Recent unpublished data from Dr. Longman's lab (collaborator) suggest a distinct intestinal dysbiosis in Crohn's associated SpA. But relationship between this microbiome and MRI changes is yet to be determined.

Identifying inflammation earlier on MRI- in the absence of clinical symptoms will provide an opportunity to intervene early with available therapies, such as- biologics etc. Asymptomatic MRI changes could be a marker of underlying systemic inflammation- which is a risk factor for poor outcomes in Crohn's associated SpA. Studying association between whole spine MRI changes with patient reported outcomes) may facilitate informed clinical decision making to initiate targeted therapy to prevent progression of structural damage. Understanding microbial dysregulation in this population, and correlation with MRI changes, could lead to development of therapy targeted to restore intestinal symbiosis.

Conditions

Interventions

OTHER

No intervention

No drug or device intervention. However, participants will receive MRI of their spine, answer questionnaires, provide clinical history as well as blood and stool sample. Joint exams will also be performed on all participants.

Sponsors & Collaborators

  • Weill Medical College of Cornell University

    collaborator OTHER

  • Hospital for Special Surgery, New York

    lead OTHER

Principal Investigators

  • Lisa Mandl, MD MPH · Hospital for Special Surgery, New York

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-30
Primary Completion
2019-01-31
Completion
2021-01-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02709694 on ClinicalTrials.gov