Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2026-01-05 @ 2:08 AM
Study NCT ID:
NCT02332356
Status:
UNKNOWN
Last Update Posted:
2023-11-27
First Post:
2015-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D020969', 'term': 'Disease Attributes'}], 'ancestors': [{'id': 'D005759', 'term': 'Gastroenteritis'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D007410', 'term': 'Intestinal Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D001379', 'term': 'Azathioprine'}, {'id': 'D000068879', 'term': 'Adalimumab'}, {'id': 'D000069285', 'term': 'Infliximab'}], 'ancestors': [{'id': 'D013872', 'term': 'Thionucleosides'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D015122', 'term': 'Mercaptopurine'}, {'id': 'D011687', 'term': 'Purines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009705', 'term': 'Nucleosides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2014-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-11-21', 'studyFirstSubmitDate': '2015-01-04', 'studyFirstSubmitQcDate': '2015-01-04', 'lastUpdatePostDateStruct': {'date': '2023-11-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-01-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2024-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The rate of clinical remission at 104 weeks.', 'timeFrame': '104 weeks'}], 'secondaryOutcomes': [{'measure': 'The rate of hospitalization and operation', 'timeFrame': '104 weeks'}]}, 'conditionsModule': {'keywords': ['Crohn Disease', 'Inflammatory Bowel Diseases', 'Disease Attributes'], 'conditions': ['Crohn Disease']}, 'referencesModule': {'references': [{'pmid': '24732015', 'type': 'BACKGROUND', 'citation': "Takenaka K, Ohtsuka K, Kitazume Y, Nagahori M, Fujii T, Saito E, Naganuma M, Araki A, Watanabe M. Comparison of magnetic resonance and balloon enteroscopic examination of the small intestine in patients with Crohn's disease. Gastroenterology. 2014 Aug;147(2):334-342.e3. doi: 10.1053/j.gastro.2014.04.008. Epub 2014 Apr 13."}, {'pmid': '21484957', 'type': 'BACKGROUND', 'citation': "Hyun SB, Kitazume Y, Nagahori M, Toriihara A, Fujii T, Tsuchiya K, Suzuki S, Okada E, Araki A, Naganuma M, Watanabe M. Magnetic resonance enterocolonography is useful for simultaneous evaluation of small and large intestinal lesions in Crohn's disease. Inflamm Bowel Dis. 2011 May;17(5):1063-72. doi: 10.1002/ibd.21510. Epub 2010 Oct 25."}]}, 'descriptionModule': {'briefSummary': 'This randomized, controlled study aims to evaluate the impact of therapeutic intervention (step up) for the patients who are clinical remission with Magnetic Resonance Enterocolonography (MREC) active. In addition, to evaluate the impact of therapeutic step down for the patients who archived clinical and MREC remission. The primary endpoint is the rate of clinical remission at 104 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '16 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Crohn's and proven history of disease with clinical remission (CDAI\\<150)\n* Signed written consent form to enroll the study (Need agreement from deputy for patients under 20years old)\n\nExclusion Criteria:\n\n* Contraindication for infliximab, adalimumab, or azathioprine\n* Lactating woman\n* Presence of malignancy\n* Within 3 month from intestinal surgery\n* Presence of an end stoma\n* Planned surgery"}, 'identificationModule': {'nctId': 'NCT02332356', 'briefTitle': "Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Tokyo Medical and Dental University'}, 'officialTitle': "Therapeutic Optimization Study Based on MR Enterocolonography in Patients With Crohn's Disease", 'orgStudyIdInfo': {'id': 'MREC study'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'step up', 'description': 'Procedure: MREC patients receive therapeutic step up', 'interventionNames': ['Drug: azathioprine or adalimumab and infliximab']}, {'type': 'NO_INTERVENTION', 'label': 'observation step up'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'step down', 'description': 'Procedure: MREC patients receive therapeutic step down', 'interventionNames': ['Drug: azathioprine or adalimumab and infliximab']}, {'type': 'NO_INTERVENTION', 'label': 'observation step down'}], 'interventions': [{'name': 'azathioprine or adalimumab and infliximab', 'type': 'DRUG', 'armGroupLabels': ['step down', 'step up']}]}, 'contactsLocationsModule': {'locations': [{'zip': '113-8519', 'city': 'Tokyo', 'country': 'Japan', 'facility': 'Gastroenterology and Hepatology, Tokyo Medical and Dental UNIV', 'geoPoint': {'lat': 35.6895, 'lon': 139.69171}}], 'overallOfficials': [{'name': 'Toshimitsu Fujii', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tokyo Medical and Dental University Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Tokyo Medical and Dental University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Gastroenterology and Hepatology', 'investigatorFullName': 'Toshimitsu Fujii, MD PhD', 'investigatorAffiliation': 'Tokyo Medical and Dental University'}}}}