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

Not Applicable

Withdrawn

• Conditions: Inflammatory Bowel Diseases
• Interventions: Diagnostic Test: Fecal calprotectin; Other: Routine care

• Registration Number: NCT03633669
• Lead Sponsor: McMaster University

Brief Summary

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study First Submitted: 2018-07-27
• Study First Submitted QC: 2018-08-13
• Study First Posted: 2018-08-16
• Study Start: 2018-09-01
• Status Verified: 2019-08
• Last Update Submitted: 2019-08-13
• Last Update Posted: 2019-08-15
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Tight control	Fecal calprotectin	Group that will receive fecal calprotectin testing every 3 months
Standard care	Routine care	Routine clinical care

Primary Outcome Measures

Name	Time	Method
Rate of Relapse	12 months	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

Secondary Outcome Measures

Name	Time	Method
Rate of Clinical symptom relapse	12 months	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
Incidence of Hospitalizations	12 months	Based on admission to hospital for IBD-related reasons
Incidence of change in medical therapies	12 months	Increased doses of current biologics, switch to different biologics, addition of immunomodulators, or steroid use would all qualify as changes in medical therapies