New study aims to predict Crohn's treatment success with scans and blood tests
NCT ID NCT03646708
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study looks at 112 people with small bowel Crohn's disease who are starting a new biologic therapy. Researchers use MRI scans and blood protein tests to see if they can predict who will achieve remission without steroids after one year. The goal is to help doctors choose the right treatment earlier and avoid ineffective therapies.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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112 people
The number who actually took part.
- Started
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May 2018
- Expected to finish
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May 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
SBCD patients starting a new biologic therapy
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion: * Patient who have had a prior standard of care (SOC) ileocolonoscopy with biopsies confirming SBCD * And with active disease visible on a baseline MRE (small bowel only or ileocolonic disease) * And are being initiated on a biologic (anti-TNFs, vedolizumab and ustekinumab) approved for CD, regardless of their prior biologic exposure, will be recruited. * Prior studies have confirmed active SBCD noted on MRE as consistent with active disease using histopathology as reference standard.45 Exclusion: * Patients who are pregnant: Subjects will not be tested for pregnancy on protocol outside of standard of care and is usually done prior to clinical radiological and endoscopic testing for patients of childbearing potential per standard of care standard operating procedures. If any subject is found to be pregnant during the study they will be discontinued from the study visit protocol and managed by primary gastroenterologist per standard of care. * Less than 18 years of age * Unable to provide informed consent * Chronic kidney disease that precludes contrast administration * Implanted medical devices that are contraindicated for MRI * Individuals with colonic involvement without SB disease will also be excluded * Planned surgery prior to the first follow-up MRE * Inpatient scans will only be included if this is an MRE and adequate small bowel distension with appropriate contrast has been achieved, in the opinion of the radiology co-investigator. * Any subject condition or situation which, in the opinion of the Investigator or regulatory authorities, interferes with optimal study participation of the participant or produces/could produce significant risk to the subject.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Washington University School of Medicine
St Louis, Missouri, 63110, United States
More trials for these conditions
Other studies related to the condition(s) this trial covers.