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Response Assessment in SB CD

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ClinicalTrials.gov Identifier: NCT03646708
Recruitment Status : Recruiting
First Posted : August 24, 2018
Last Update Posted : August 28, 2018
Sponsor:
Collaborator:
American College of Gastroenterology
Information provided by (Responsible Party):
Washington University School of Medicine

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.

Condition or disease
Small Bowel Crohn's Disease

  Show Detailed Description

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Study Type : Observational
Estimated Enrollment : 200 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Triangular Phenotyping and Response Assessment in Small Bowel Crohn's Disease Using Magnetic Resonance Enterography (MRE) and Novel Proteomic Biomarkers
Actual Study Start Date : May 9, 2018
Estimated Primary Completion Date : May 30, 2023
Estimated Study Completion Date : May 30, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Crohn's Disease

Group/Cohort
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.



Primary Outcome Measures :
  1. Corticosteroid free remission (CFR) [ Time Frame: 52 ± 4 weeks ]
    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.


Secondary Outcome Measures :
  1. Mucosal healing (MH) [ Time Frame: 52 ± 4 weeks. ]
    Secondary endpoint will be MH in the terminal ileum using criteria of Simple Endoscopic Score for Crohn's Disease (SES-CD) score of 0 to 2 at the ileocolonoscopy at 52 ± 4 weeks.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
SBCD patients starting a new biologic therapy
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03646708


Contacts
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Contact: Darren Nix 314-362-3201 nixd@wustl.edu
Contact: Parakkal Deepak, MBBS, MS 314-362-3201 deepak.parakkal@wustl.edu

Locations
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United States, Missouri
Washington University School of Medicine Recruiting
Saint Louis, Missouri, United States, 63110
Contact: Darren Nix    314-362-3201    bnix@DOM.wustl.edu   
Sponsors and Collaborators
Washington University School of Medicine
American College of Gastroenterology
Investigators
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Principal Investigator: Parakkal Deepak, MBBS, MS Washington University School of Medicine

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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03646708     History of Changes
Other Study ID Numbers: 201805058
First Posted: August 24, 2018    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Crohn Disease
Inflammatory Bowel Diseases
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases