Response Assessment in SB CD

Launched by WASHINGTON UNIVERSITY SCHOOL OF MEDICINE · Aug 23, 2018

Keywords

ClinConnect Summary

This clinical trial is focused on finding better ways to measure and understand the activity of small bowel Crohn's disease, which affects about 70% of patients with this condition. Researchers want to see if certain imaging techniques and a new blood test can accurately predict how well patients respond to a specific type of treatment called biologic therapy. They will follow a group of patients who are starting this therapy, using advanced imaging and blood tests to gather information about their disease and treatment response over time. The goal is to create a tool that helps doctors identify which patients may need changes to their treatment early on, improving their care.

To be eligible for this trial, patients must be over 18 years old and have been diagnosed with small bowel Crohn's disease through prior examinations. They should have visible signs of active disease on a specific type of imaging called MRE, and they must be starting a biologic treatment approved for Crohn's disease. Participants can expect to undergo imaging and blood tests at various points during the study, which will help researchers learn more about how to tailor treatments for individual patients. It's important to note that certain individuals, such as those who are pregnant or have specific health issues, will not be able to participate in the trial.

Gender

ALL

Eligibility criteria

• 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.