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Center for Global Research Data

Impact of Ulcer Size and Extent of Inflammation On Ability To Achieve Endoscopic Healing In Crohn’s Disease: An EXTEND Post-Hoc Analysis

Lead Investigator: Neeraj Narula, McMaster University
Title of Proposal Research: Impact of Ulcer Size and Extent of Inflammation On Ability To Achieve Endoscopic Healing In Crohn’s Disease: An EXTEND Post-Hoc Analysis
Vivli Data Request: 5567
Funding Source: None
Potential Conflicts of Interest: None

Summary of the Proposed Research:

Crohn’s disease is an inflammatory condition of the bowel which affects 1 in 250 patients in North America. Endoscopic healing of the bowel has become a goal of treatment for patients with Crohn’s disease. Clinical trials conducted in Crohn’s disease for new therapies need to demonstrate the ability to heal the mucosa before receiving regulatory authority approvals for use. However, nothing is known about the impact of lesion size and distribution on the ability to achieve endoscopic healing. Arbitrary scoring systems like the Simplified Endoscopic Score for Crohn’s disease (SES-CD) or the Crohn’s disease Endoscopic Index Score (CDEIS) are used to grade inflammation, but the scores appear to be arbitrary, as it has been shown patients with higher scores are just as likely to heal as those with lower scores (Narula et al. Am J Gastroenterol 2020). This study looks to validate the pre-existing work by myself and look at the EXTEND database and determine whether patients who have more extensive inflammation at baseline and larger ulcer sizes are less likely to achieve endoscopic healing. Univariate analyses will be conducted to look for baseline variables which have a significant relationship with the outcome of interest – endoscopic healing at week 54. This will include evaluation of specific endoscopic features – for example, large ulcers vs. not large ulcers in the ileum.

Requested Studies:

A Multicenter, Randomized, Double-Blind, Placebo-Controlled Study of the Human Anti-TNF Monoclonal Antibody Adalimumab Endoscopy Trial to Evaluate the Effects on Mucosal Healing in Subjects With Crohn’s Disease Involving the Colon
Sponsor: AbbVie
Study ID: NCT00348283
Sponsor ID: M05-769