Ignite Creation Date:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-31 @ 7:32 AM
Study NCT ID:
NCT07421258
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-19
First Post:
2025-09-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Retrospective Study to Evaluate Treat-to-Target and Disease Modification in Adult Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 2000}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-02-15', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-02', 'completionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-02-13', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2026-02-13', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-09', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants Managed Using Treat-to-Target (T2T)', 'timeFrame': '12 Weeks', 'description': 'Defined as a participant with a therapeutic modification \\[dose escalation, change in therapy\\] within 12 weeks following any objective disease monitoring that demonstrated active disease.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Disease', "Crohn's Disease", 'Ulcerative Colitis', 'Treat-to-Target'], 'conditions': ["Crohn's Disease", 'Ulcerative Colitis']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=H25-909', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': "Inflammatory Bowel Disease (IBD), encompassing Crohn's Disease (CD) and Ulcerative Colitis (UC), is a chronic, relapsing, and often disabling condition characterized by inflammation of the gastrointestinal tract. A treat-to-target strategy (T2T) is recommended by international guidelines to optimize long-term outcomes in IBD. The purpose of this study is to describe the real-life implementation of T2T in IBD worldwide and the association between using a T2T strategy and disease outcomes.\n\nThis is a multi-country, observational, retrospective (non-interventional) study with a cross-sectional component based upon a sample of adult participants with IBD. All objectives will be assessed for IBD and then for CD/UC separately. Primary and secondary objectives will be assessed for the overall population over the 24 months study period.\n\nAs this is an observational study, enrolled participants will be managed and followed up according to the standard practice.\n\nRetrospective chart review over the 24-months from date of inclusion will allow us to collect the variables of interest by using an e-CRF. There will be no additional burden for participants in this trial. Study visits will not be required as this is a retrospective chart review."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '20 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult participants with a physician-confirmed diagnosis of Ulcerative Colitis (UC) or Crohn's Disease (CD) \\>= 2 years prior to enrolment.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Adult male and female participants (\\>= 18 years old) at the inclusion date who present within the usual course of care\n* Participants able to provide voluntary informed consent prior to any study data collection\n* Participant diagnosed with Crohn's Disease (CD) or Ulcerative Colitis (UC) for at least 24 months at the inclusion date\n* With \\>= 24 months of available medical records from the inclusion date\n\nExclusion Criteria:\n\n* Participants who had received treatment with any investigational drug/device/intervention over the past 24 months prior to the enrolment\n* Participants under legal protection\n* History of proctocolectomy"}, 'identificationModule': {'nctId': 'NCT07421258', 'acronym': 'TATOO', 'briefTitle': "A Retrospective Study to Evaluate Treat-to-Target and Disease Modification in Adult Participants With Crohn's Disease and Ulcerative Colitis in Real World Setting", 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'Treat-to-Target and Disease Modification in Inflammatory Bowel Disease: A Worldwide Routine Practice Study', 'orgStudyIdInfo': {'id': 'H25-909'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Adults with Inflammatory Bowel Disease', 'description': 'Participants will be managed and followed according to the standard practice.'}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Colla Cunneen', 'role': 'CONTACT', 'email': 'colla.cunneen@abbvie.com', 'phone': '708-650-3696'}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}