Ignite Creation Date:
2025-12-24 @ 11:09 PM
Ignite Modification Date:
2026-01-02 @ 9:11 AM
Study NCT ID:
NCT03633669
Status:
WITHDRAWN
Last Update Posted:
2019-08-15
First Post:
2018-07-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Real-world Tight Control Management of Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Funding', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2018-09-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-08', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2019-08-13', 'studyFirstSubmitDate': '2018-07-27', 'studyFirstSubmitQcDate': '2018-08-13', 'lastUpdatePostDateStruct': {'date': '2019-08-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Rate of Relapse', 'timeFrame': '12 months', '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"}], 'secondaryOutcomes': [{'measure': 'Rate of Clinical symptom relapse', 'timeFrame': '12 months', '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"}, {'measure': 'Incidence of Hospitalizations', 'timeFrame': '12 months', 'description': 'Based on admission to hospital for IBD-related reasons'}, {'measure': 'Incidence of change in medical therapies', 'timeFrame': '12 months', 'description': 'Increased doses of current biologics, switch to different biologics, addition of immunomodulators, or steroid use would all qualify as changes in medical therapies'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of Crohn's disease or ulcerative colitis based on clinical, endoscopic, radiologic or histologic criteria.\n2. Followed by a gastroenterologist at Hamilton Health Sciences, St. Joseph's Healthcare Hamilton, and London Health Sciences\n3. Aged 18 or older\n4. In clinical remission according to the clinical symptom assessment (Partial Mayo score \\< 2 or Harvey-Bradshaw Index \\< 4)\n5. Currently treated with adalimumab\n\nExclusion Criteria:\n\n1. Current abdominal abscess\n2. Inability or unwillingness to provide informed consent\n3. Any other condition, which in the opinion of the investigators would impede competence or compliance or possibly hinder completion of the study"}, 'identificationModule': {'nctId': 'NCT03633669', 'briefTitle': 'Effect of Real-world Tight Control Management of Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'McMaster University'}, 'officialTitle': 'Effect of Real-world Tight Control Management of Inflammatory Bowel Disease', 'orgStudyIdInfo': {'id': '4'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Tight control', 'description': 'Group that will receive fecal calprotectin testing every 3 months', 'interventionNames': ['Diagnostic Test: Fecal calprotectin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Standard care', 'description': 'Routine clinical care', 'interventionNames': ['Other: Routine care']}], 'interventions': [{'name': 'Fecal calprotectin', 'type': 'DIAGNOSTIC_TEST', 'description': 'Testing every 3 months', 'armGroupLabels': ['Tight control']}, {'name': 'Routine care', 'type': 'OTHER', 'description': 'As per treating gastroenterologist', 'armGroupLabels': ['Standard care']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'McMaster University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}