Response Assessment in SB CD

NCT03646708 | Active Not Recruiting

• 1 other identifier: 201805058
• Study Type: observational
• Target: 112
• Locations: 1 country
• Sites: 1

Brief Summary

The small bowel (SB) is involved in \~70% of patients with Crohn's disease (CD). There is an unmet need for accurate and clinically meaningful methods to measure small bowel Crohn's Disease (SBCD) activity. This is particularly relevant as the field moves towards "treat-to-target" management strategies. The overall objective of this proposal is to establish that radiologic transmural response (TR) and a novel proteomic biomarker are accurate and clinically meaningful predictors of SBCD inflammatory activity and response to biologic therapy. To address this objective, we will establish a prospectively followed cohort of SBCD patients starting a new biologic therapy. These patients will be comprehensively phenotyped using state of the art MRE imaging, proteomic profiling and clinical disease activity indices. We will use this innovative approach of triangular phenotyping to address our central hypothesis that "Corticosteroid-free remission at 52 weeks after biologic therapy initiation is predicted by short term radiologic TR or early changes in serum proteomic biomarker profiles". Serum proteomic biomarker profiles will be evaluated using SOMAscanTM (SomaLogic, Inc., Boulder, Colorado, USA), a novel platform allowing high-throughput analysis of proteins through Slow Off-rate Modified DNA Aptamer (SOMAmer)-based capture array. Our preliminary data using SOMAscan identified a panel of 12 serum proteins whose differential expression pattern from Week 0 to week 6 after starting a biologic can predict week 14 clinical remission in SBCD patients. The significance of this proposal is that the development of an early predictive model using radiological and serum endpoints will facilitate a personalized algorithmic approach to identify patients with SBCD who will benefit from treatment escalation or change to a different biologic. Furthermore, it will be used to generate a tangible career tool of a prospectively enrolled patient cohort to further study radiologic and biomarker predictors of response in SBCD. This award will also enhance the career of the principal investigator by facilitating acquisition of an enhanced skill set in clinical research, bioinformatics and biomarker discovery.

Conditions

Small Bowel Crohn's Disease

Outcome Measures

Primary Outcomes (1)

• Corticosteroid free remission (CFR)

  Corticosteroid free remission (CFR) will be assessed at the in-person visit at 52 ± 4 weeks where remission will be defined as using Harvey-Bradshaw index (HBI) criteria of 4 points or lower, free of any corticosteroid usage for ≥30 days.

  52 ± 4 weeks

Secondary Outcomes (1)

• Mucosal healing (MH)

  52 ± 4 weeks.

Study Arms (1)

SBCD patients starting a new biologic therapy

As part of your standard clinical care (soc), patient will be started on a biologic (anti-tumor necrosis factor (TNF)s, vedolizumab and ustekinumab) based on your interactions with your treating gastroenterologist after standard of care clinical assessment.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

SBCD patients starting a new biologic therapy

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead
• American College of Gastroenterology: collaborator

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Study Officials

• Parakkal Deepak, MBBS, MS

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 23, 2018
• First Posted: August 24, 2018
• Study Start: May 9, 2018
• Primary Completion (Estimated): May 30, 2027
• Study Completion (Estimated): May 30, 2027
• Last Updated: March 10, 2026

Record last verified: 2026-03

Locations

US (1)