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

NCT03633669 | Withdrawn

• 1 other identifier: 4
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Inflammatory Bowel Diseases

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Rate of Clinical symptom relapse

  12 months

• Incidence of Hospitalizations

  12 months

• Incidence of change in medical therapies

  12 months

Study Arms (2)

Tight control

ACTIVE COMPARATOR

Group that will receive fecal calprotectin testing every 3 months

Diagnostic Test: Fecal calprotectin

Standard care

PLACEBO COMPARATOR

Routine clinical care

Other: Routine care

Interventions

Fecal calprotectin DIAGNOSTIC_TEST

Testing every 3 months

Tight control

Routine care OTHER

As per treating gastroenterologist

Standard care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• McMaster University: lead

MeSH Terms

Conditions

Inflammatory Bowel Diseases

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2018
• First Posted: August 16, 2018
• Study Start: September 1, 2018
• Primary Completion: December 31, 2019
• Study Completion: December 31, 2019
• Last Updated: August 15, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share