Ignite Creation Date:
2025-12-24 @ 9:25 PM
Ignite Modification Date:
2026-01-24 @ 4:57 PM
Study NCT ID:
NCT04775732
Status:
COMPLETED
Last Update Posted:
2021-08-05
First Post:
2021-02-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'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'}, {'id': 'D003092', 'term': 'Colitis'}, {'id': 'D003108', 'term': 'Colonic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'pragmatic cluster trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 187}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2019-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-29', 'studyFirstSubmitDate': '2021-02-25', 'studyFirstSubmitQcDate': '2021-02-26', 'lastUpdatePostDateStruct': {'date': '2021-08-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-03-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'number of patients with infliximab failure', 'timeFrame': 'one year', 'description': 'number of patients with infliximab failure after one year (infliximab failure = infliximab discontinuation, IBD related surgery, IBD related hospitalization, add-on IBD treatment, and allergic reaction to infliximab)'}], 'secondaryOutcomes': [{'measure': 'number of TL measurements per patient per year', 'timeFrame': 'one year'}, {'measure': 'percentage of interval changes (shortening, prolongation, bidirectional)', 'timeFrame': 'one year'}, {'measure': 'number of patients with infliximab discontinuation', 'timeFrame': 'one year', 'description': 'number of patients with discontinuation of infliximab'}, {'measure': 'percentage of patients with sustained clinical remission', 'timeFrame': 'one year', 'description': 'number of patients with physician global assessment \\<1 and all visits'}, {'measure': 'number of patients with mucosal remission', 'timeFrame': 'one year', 'description': 'number of patients with mucosal remission after one year. (Mucosal remission = simple endoscopic score for CD \\<3, Rutgeertscore \\<i2 for, Mayo endoscopic subscore \\<1 and faecal calprotectin \\<250 µg/ml. Endoscopy and/or faecal calprotectin between 6 and 12 months after inclusion. If endoscopy and faecal calprotectin at the same moment, then endoscopy was dominant)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['therapeutic drug monitoring', 'inflammatory bowel disease', 'point of care testing', 'infliximab'], 'conditions': ['Crohn Disease', 'Ulcerative Colitis']}, 'descriptionModule': {'briefSummary': 'This is a comparative pragmatic trial in patients with UC and CD on maintenance treatment with IFX. All IBD patients from cohort A with maintenance IFX treatment at a referral IBD clinic are prospectively included between June and August 2018. An ultra-proactive IFX TDM algorithm is applied as follows. All patients have an ELISA TL measurement at baseline, of which the result determined the follow-up pathway: (A) TL between 3-7μg/mL: continuation at same dose and interval; (B) TL \\>7μg/mL: interval prolongation allowed; (C) TL \\<3μg/mL: interval shortening with minimum 2 weeks, with the next IFX TL measured using a POCT. (i) If the POCT showed an IFX TL \\<3μg/mL, dose was optimized ad hoc using a linear dosing formula (Dosen = (TL target \\* Dose n-1) / TL measured), followed by a new POCT test at next visit with the same interval. (ii) If the POCT showed an IFX TL ≥3µg/mL, no additional dose was given and routine TL testing with ELISA was retaken at next visit. At every visit this algorithm was reapplied to all patients.\n\nThe patients from cohort A will be compared with the patients from cohort B. The patients in cohort B receive maintenance IFX treatment at a referral IBD clinic during the same period. Dose adjustment are done based on standard of care reactive TDM of IFX and clinical symptoms. Data will be collected retrospectively to avoid treatment optimization bias.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all adult IBD patients treated for at least 14 weeks with infliximab were included\n\nExclusion Criteria:\n\n* induction treatment with infliximab (\\<14 weeks)\n* treatment with other biological for IBD'}, 'identificationModule': {'nctId': 'NCT04775732', 'briefTitle': 'Ultra-proactive Therapeutic Drug Monitoring in Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Imelda GI Clinical Research Center'}, 'officialTitle': 'Ultra-proactive Therapeutic Drug Monitoring of Infliximab Based on Point-of-care-testing in Inflammatory Bowel Disease: a Pragmatic Trial', 'orgStudyIdInfo': {'id': '200840'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ultra proactive arm', 'interventionNames': ['Biological: infliximab therapeutic drug monitoring']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'reactive arm', 'interventionNames': ['Biological: infliximab therapeutic drug monitoring']}], 'interventions': [{'name': 'infliximab therapeutic drug monitoring', 'type': 'BIOLOGICAL', 'description': 'dose optimization of infliximab based on a predefined dosing algorithm', 'armGroupLabels': ['reactive arm', 'ultra proactive arm']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2820', 'city': 'Bonheiden', 'country': 'Belgium', 'facility': 'Imelda GI clinical research center', 'geoPoint': {'lat': 51.02261, 'lon': 4.54714}}, {'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'AZ Sint Lucas', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Imelda GI Clinical Research Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Peter Bossuyt', 'investigatorAffiliation': 'Imelda GI Clinical Research Center'}}}}