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

Primary Purpose

Inflammatory Bowel Diseases

Status
Withdrawn
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Fecal calprotectin
Routine care
Sponsored by
McMaster University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inflammatory Bowel Diseases

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Active Comparator

    Placebo Comparator

    Arm Label

    Tight control

    Standard care

    Arm Description

    Group that will receive fecal calprotectin testing every 3 months

    Routine clinical care

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    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
    Incidence of Hospitalizations
    Based on admission to hospital for IBD-related reasons
    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

    Full Information

    First Posted
    July 27, 2018
    Last Updated
    August 13, 2019
    Sponsor
    McMaster University
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03633669
    Brief Title
    Effect of Real-world Tight Control Management of Inflammatory Bowel Disease
    Official Title
    Effect of Real-world Tight Control Management of Inflammatory Bowel Disease
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2019
    Overall Recruitment Status
    Withdrawn
    Why Stopped
    Funding
    Study Start Date
    September 1, 2018 (Anticipated)
    Primary Completion Date
    December 31, 2019 (Anticipated)
    Study Completion Date
    December 31, 2019 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    McMaster University

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Inflammatory Bowel Diseases

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    0 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Tight control
    Arm Type
    Active Comparator
    Arm Description
    Group that will receive fecal calprotectin testing every 3 months
    Arm Title
    Standard care
    Arm Type
    Placebo Comparator
    Arm Description
    Routine clinical care
    Intervention Type
    Diagnostic Test
    Intervention Name(s)
    Fecal calprotectin
    Intervention Description
    Testing every 3 months
    Intervention Type
    Other
    Intervention Name(s)
    Routine care
    Intervention Description
    As per treating gastroenterologist
    Primary Outcome Measure Information:
    Title
    Rate of Relapse
    Description
    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
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Rate of Clinical symptom relapse
    Description
    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
    Time Frame
    12 months
    Title
    Incidence of Hospitalizations
    Description
    Based on admission to hospital for IBD-related reasons
    Time Frame
    12 months
    Title
    Incidence of change in medical therapies
    Description
    Increased doses of current biologics, switch to different biologics, addition of immunomodulators, or steroid use would all qualify as changes in medical therapies
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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