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NCT02709694 · ClinicalTrials.gov registry record

Imaging Biomarkers in Crohn's Associated Spondyloarthritis

A clinical trial, sponsored by Hospital for Special Surgery, New York.

Completed
Registry status
33
Enrollment target

NCT02709694: Completed study, sponsored by Hospital for Special Surgery, New York.

NCT02709694 is a clinical trial that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 33 participants. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT02709694 has completed, sponsored by Hospital for Special Surgery, New York.

COMPLETED
Registry status
33 participants
Enrollment target

Study 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 Recent unpublished data from Dr.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 the

Primary Outcome

MRIs were independently read and scored by 2 expert rheumatologists and 1 newly trained rheumatologist reader, blinded to any clinical information. MRIs were evaluated and scored for presence of bone marrow edema (BME) and structural lesions (erosion, fat metaplasia, backfill and ankylosis) using a validated scoring method originally derived from the Spondyloarthritis Research Consortium of Canada SIJ module. MRI was considered "positive" for presence of sacroiliitis if it met global evaluation,

Interventions

  • OTHER No intervention

Trial Details

FieldValue
Enrollment Target 33 participants
Start Date 2016-04
Est. Completion 2021-01

What the finished NCT02709694 record still lists

NCT02709694 is an observational study that tracks outcomes without assigning an intervention. The registry caps enrollment at 33 participants, a relatively small participant target.

The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.

NCT02709694 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT02709694 about?

NCT02709694 is a clinical study titled "Imaging Biomarkers in Crohn's Associated Spondyloarthritis". 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 Sp...

What is the current status of trial NCT02709694?

This trial is currently completed. The enrollment target is 33 participants. The study started on 2016-04. Estimated completion is 2021-01.

What interventions are being tested in trial NCT02709694?

The interventions under investigation include: No intervention (OTHER).

Who is sponsoring clinical trial NCT02709694?

This trial is sponsored by Hospital for Special Surgery, New York, which has 194 total clinical trials registered on ClinicalTrials.gov.

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Source: ClinicalTrials.gov NCT02709694, the US trial registry maintained by the National Library of Medicine. NCT02709694 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.