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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 is a clinical trial that has completed, run by Hospital for Special Surgery, New York. The registered enrollment target is 33 participants.
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 Recent unpublished data from Dr.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
Interventions
- OTHER No intervention
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 33 participants |
| Start Date | 2016-04 |
| Est. Completion | 2021-01 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02709694
The ClinicalTrials.gov registry entry for NCT02709694 describes a study currently listed as completed, categorized as an unspecified phase. The registered enrollment target is 33 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Hospital for Special Surgery, New York, which has 194 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which No intervention is the first listed.
NCT02709694 reports 0 study locations.
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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