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

Inflammatory Bowel Diseases Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03633669
• Other study ID #: 4
• Status: Withdrawn
• Phase: N/A
• Start date: September 1, 2018
• Est. completion date: December 31, 2019

Study information

• Verified date: August 2019
• Source: McMaster University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 31, 2019
• Est. primary completion date: December 31, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Inflammatory Bowel Diseases
• Intestinal Diseases

Intervention

Diagnostic Test:
• Fecal calprotectin
Testing every 3 months

Other:
• Routine care
As per treating gastroenterologist

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
McMaster University

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	Incidence of Hospitalizations	Based on admission to hospital for IBD-related reasons	12 months
Secondary	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