Ignite Creation Date:
2025-12-24 @ 5:09 PM
Ignite Modification Date:
2025-12-28 @ 11:35 PM
Study NCT ID:
NCT05157750
Status:
UNKNOWN
Last Update Posted:
2021-12-15
First Post:
2021-10-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Endoscopic Remission, Histologic Remission and Barrier Healing for Predicting Disease Behaviour in IBD
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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-01-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-12', 'completionDateStruct': {'date': '2022-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-12-14', 'studyFirstSubmitDate': '2021-10-19', 'studyFirstSubmitQcDate': '2021-12-14', 'lastUpdatePostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-12-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Predictive value of endoscopic remission in ulcerative colitis', 'timeFrame': '2 years', 'description': 'Endoscopic remission will be assessed using the Mayo Endoscopy Score in ulcerative colitis'}, {'measure': "Predictive value of endoscopic remission in Crohn's disease", 'timeFrame': '2 years', 'description': "Endoscopic remission will be assessed using the simplified endoscopic index of severity (SES-CD) in Crohn's disease"}, {'measure': 'Predictive value of histologic remission in ulcerative colitis', 'timeFrame': '2 years', 'description': 'Histologic remission will be assessed using the Robarts Histology Index and the Nancy Histology Index in ulcerative colitis'}, {'measure': "Predictive value of histologic remission in Crohn's disease", 'timeFrame': '2 years', 'description': "Histologic remission will be assessed using a modified Riley Score in Crohn's disease"}, {'measure': 'Predictive value of barrier healing', 'timeFrame': '2 years', 'description': 'Barrier healing will be assessed using the well-established Watson-Score as a semiquantitative grading system of the intestinal barrier function'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Diseases']}, 'referencesModule': {'references': [{'pmid': '37881628', 'type': 'DERIVED', 'citation': 'Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CI, Vitali F, Zundler S, Waldner MJ, Hartmann A, Neurath MF. Healing of the epithelial barrier in the ileum is superior to endoscopic and histologic remission for predicting major adverse outcomes in ulcerative colitis. Front Med (Lausanne). 2023 Oct 10;10:1221449. doi: 10.3389/fmed.2023.1221449. eCollection 2023.'}, {'pmid': '36279923', 'type': 'DERIVED', 'citation': 'Rath T, Atreya R, Bodenschatz J, Uter W, Geppert CE, Vitali F, Fischer S, Waldner MJ, Colombel JF, Hartmann A, Neurath MF. Intestinal Barrier Healing Is Superior to Endoscopic and Histologic Remission for Predicting Major Adverse Outcomes in Inflammatory Bowel Disease: The Prospective ERIca Trial. Gastroenterology. 2023 Feb;164(2):241-255. doi: 10.1053/j.gastro.2022.10.014. Epub 2022 Oct 21.'}]}, 'descriptionModule': {'briefSummary': 'Within this study, the investigators aim to directly compare the value of endoscopic remission, histologic remission and barrier healing for predicting long-term disease behavior in a large cohort of clinically remittent IBD patients.', 'detailedDescription': "Mucosal healing is a key therapeutic goal in the management of patients with inflammatory bowel diseases (IBD) that is associated with favorable long-term disease outcome. In addition, histologic remission is an emerging endpoint and first data suggest that functional assessment of the integrity of the intestinal barrier, i.e. barrier healing, by confocal laser endomicroscopy (CLE) correlates to clinical disease behavior and outcome.\n\nWithin this study, the investigators will prospectively include IBD patients in clinical remission and assess endoscopic remission, histologic remission and barrier healing during baseline ileocolonoscopy. Participants will then be closely followed up in the IBD outpatient department of the University Hospital Erlangen every 4 to 8 weeks for participants under biological therapy and every 8 weeks for participants under conventional therapy. At each visit, clinical disease activity using the Mayo Clinical Score (MCS) and the Crohn's disease activity Index (CDAI), respectively, routine laboratory parameters and current and past medications will be recorded. Further, at each visit, major clinical events (MCE), defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded. The primary endpoint of this study is to comparatively assess the predictive values of barrier healing, endoscopic remission and histologic remission for predicting occurrence of MCE in IBD patients in clinical remission"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Consecutive patients with an established IBD diagnosis for at least 12 months duration presenting in clinical remission presenting at the Department of Gastroenterology of the University Hospital Erlangen will be prospectively included.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients with an established IBD diagnosis for at least 12 months duration\n* IBD patients in clinical remission\n\nExclusion Criteria:\n\n* patients with poor bowel preparation\n* patients with total colectomy,\n* patients with concomitant beta blocker therapy,\n* patients with known allergy to fluorescein\n* patients with a planned change in IBD-related pharmacotherapy'}, 'identificationModule': {'nctId': 'NCT05157750', 'acronym': 'ERIca', 'briefTitle': 'Endoscopic Remission, Histologic Remission and Barrier Healing for Predicting Disease Behaviour in IBD', 'organization': {'class': 'OTHER', 'fullName': 'University of Erlangen-Nürnberg Medical School'}, 'officialTitle': 'Direct Comparison of Endoscopic and Histologic Remission and Barrier Healing for Predicting Long Term Disease Behaviour in Clinically Remittent IBD Patients: the Prospective ERIca Study', 'orgStudyIdInfo': {'id': 'ERIca Study'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'IBD patients with endoscopic remission', 'description': 'No intervention will be administered. All patients with endoscopic remission will be monitored for the future development of major clinical events. Diagnostic performances of endoscopic remission for predicting major clinical events will be calculated.', 'interventionNames': ['Other: Recording of major clinical events']}, {'label': 'IBD patients with histologic remission', 'description': 'No intervention will be administered. All patients with histologic remission will be monitored for the future development of major clinical events. Diagnostic performances of histologic remission for predicting major clinical events will be calculated.', 'interventionNames': ['Other: Recording of major clinical events']}, {'label': 'IBD patients with barrier healing', 'description': 'No intervention will be administered. All patients with barrier healing will be monitored for the future development of major clinical events. Diagnostic performances of barrier healing for predicting major clinical events will be calculated.', 'interventionNames': ['Other: Recording of major clinical events']}], 'interventions': [{'name': 'Recording of major clinical events', 'type': 'OTHER', 'description': 'During follow-up, major clinical events, defined as (i) disease flare; (ii) IBD-related hospitalization, (iii) IBD-related surgery, (iv) necessity for initiation of systemic steroids, immunosuppressants or biologics; (v) necessity for escalation of an existing biological therapy, will be recorded.', 'armGroupLabels': ['IBD patients with barrier healing', 'IBD patients with endoscopic remission', 'IBD patients with histologic remission']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91054', 'city': 'Erlangen', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Timo Rath, M.D.', 'role': 'CONTACT', 'email': 'timo.rath@uk-erlangen.de', 'phone': '49 9131', 'phoneExt': '85 45041'}], 'facility': 'University Hospital Erlangen', 'geoPoint': {'lat': 49.59099, 'lon': 11.00783}}], 'centralContacts': [{'name': 'Timo Rath, MD', 'role': 'CONTACT', 'email': 'timo.rath@uk-erlangen.de', 'phone': '+49 913185-35000'}], 'overallOfficials': [{'name': 'Timo Rath, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Erlangen, Department of Medicine 1'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Erlangen-Nürnberg Medical School', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor for Endoscopy, Consultant in Gastroenterology', 'investigatorFullName': 'Timo Rath', 'investigatorAffiliation': 'University of Erlangen-Nürnberg Medical School'}}}}