CompletedNot Applicable

Significance and Outcome of Magnetic Resonance Enterography Revealing Sacroiliitis in Crohn's Disease: A Pilot Study

United States27 participantsStarted 2022-03-14

Plain-language 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.

Who can participate

Age range

18 Years – 100 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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)

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)

Timeframe: Intervention Visit 1 (Day 1)

Significance of sacroiliitis features/lesions seen on Magnetic Resonance Enterography (MRE)

Timeframe: Intervention Visit 1 (Day 1)

Trial details

NCT IDNCT05203926

SponsorNYU Langone Health

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-11-04

View on ClinicalTrials.gov More Sacroiliitis trials