Relationship Between Baseline Burden of Disease and TDM in Ulcerative Colitis

NCT03808506 · Status: WITHDRAWN · Type: OBSERVATIONAL

Last updated 2023-03-09

No results posted yet for this study

Summary

Ulcerative colitis (UC) is a chronic inflammatory bowel disease which often follows a relapsing/remitting course. Anti-TNF therapies are proven to be effective in UC and studies indicate that having adequate drug levels correlate with improved patient outcomes. It is unknown, however, if a high burden of disease at baseline impacts drug utilization or loss. In this study, we investigate whether measures of high burden of disease (fecal calprotectin, bowel ultrasound, and colonoscopy) at baseline predicts low drug levels after standard anti-TNF induction therapy.

Conditions

Interventions

DIAGNOSTIC_TEST

Fecal calprotectin

Stool test to look at baseline burden of inflammation

Sponsors & Collaborators

  • London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's

    lead OTHER

Principal Investigators

  • Brian Yan, H.B Sc, MD · Western University

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2022-06-19
Completion
2022-07-19

Countries

  • Canada

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03808506 on ClinicalTrials.gov