CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 33 enrolled
Drug / intervention
No interventionother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02709694
NCT02709694N/ACompleted

Imaging Biomarkers in Crohn's Associated Spondyloarthritis

Hospital for Special Surgery, New York·observational·Posted Mar 16, 2016·Updated Oct 25, 2021

In Brief

An observational study evaluating No intervention for Crohn's Disease and Spondyloarthritis. Completed, enrolled 33 participants across 1 site.

Detailed 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 Recent unpublished data from Dr.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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 16, 2016
Enrollment StartApr 1, 2016
Primary CompletionJan 1, 2019
Study CompletionJan 1, 2021
TodayJul 2, 2026
Enrollment to primary: 2.8 yearsPosted 10.3 years ago

Interventions

No interventionother

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.