Effect of Real-world Tight Control Management of Inflammatory Bowel Disease

Inflammatory bowel disease, which includes Crohn's disease and ulcerative colitis, is a condition that causes inflammation in the gastrointestinal tract. The disease goes through periods of remission and flare. Biomarkers such as fecal calprotectin have been proposed as a tool to monitor disease activity. Fecal calprotectin is a test that measures the amount of inflammation in the stool. Monitoring fecal calprotectin levels can assist gastroenterologists in making decisions regarding patients' IBD treatment such as whether to increase the dose of medications. A recent study showed that frequent measurement of fecal calprotectin every 3 months, also called the tight-control strategy, was associated with improved clinical outcomes in IBD patients. The purpose of this study is to assess whether the tight-control monitoring strategy, which includes fecal calprotectin monitoring every 3 months, improves clinical outcomes in IBD when performed in the real world compared to routine clinical practice.

Study Overview

• Status: Withdrawn
• Conditions: Inflammatory Bowel Diseases
• Intervention / Treatment: Diagnostic test: Fecal calprotectin; Other: Routine care

• Study Type: Interventional
• Phase: Not Applicable

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Diagnosis of Crohn's disease or ulcerative colitis based on clinical, endoscopic, radiologic or histologic criteria.
2. Followed by a gastroenterologist at Hamilton Health Sciences, St. Joseph's Healthcare Hamilton, and London Health Sciences
3. Aged 18 or older
4. In clinical remission according to the clinical symptom assessment (Partial Mayo score < 2 or Harvey-Bradshaw Index < 4)
5. Currently treated with adalimumab

Exclusion Criteria:

1. Current abdominal abscess
2. Inability or unwillingness to provide informed consent
3. Any other condition, which in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Tight control; Group that will receive fecal calprotectin testing every 3 months	Diagnostic test: Fecal calprotectin; Testing every 3 months
Placebo Comparator: Standard care; Routine clinical care	Other: Routine care; As per treating gastroenterologist

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Relapse	This will be a composite outcome of clinical symptom relapse (based on elevation of symptom scores like rise in Harvey Bradshaw Index >=3 points for Crohn's disease and Partial Mayo score >=2 points for ulcerative colitis), hospitalization, prednisone use, or IBD-related surgery	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Clinical symptom relapse	Elevation of symptom scores like rise in Harvey Bradshaw Index >= 3 points for Crohn's disease and Partial Mayo score >=2 points for ulcerative colitis	12 months
Incidence of Hospitalizations	Based on admission to hospital for IBD-related reasons	12 months
Incidence of change in medical therapies	Increased doses of current biologics, switch to different biologics, addition of immunomodulators, or steroid use would all qualify as changes in medical therapies	12 months

Collaborators and Investigators

• Sponsor: McMaster University

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2018
• Primary Completion (Anticipated): December 31, 2019
• Study Completion (Anticipated): December 31, 2019

Study Registration Dates

• First Submitted: July 27, 2018
• First Submitted That Met QC Criteria: August 13, 2018
• First Posted (Actual): August 16, 2018

Study Record Updates

• Last Update Posted (Actual): August 15, 2019
• Last Update Submitted That Met QC Criteria: August 13, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis; Inflammatory Bowel Diseases; Intestinal Diseases
• Other Study ID Numbers: 4

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No