Ignite Creation Date:
2025-12-24 @ 11:49 AM
Ignite Modification Date:
2026-02-02 @ 11:20 AM
Study NCT ID:
NCT02846961
Status:
COMPLETED
Last Update Posted:
2021-02-16
First Post:
2016-07-23
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anti CT-P13 Antibody in Moderate to Severe Inflammatory Bowel Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}, {'id': 'D003424', 'term': 'Crohn Disease'}], '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': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 280}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2020-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-02-15', 'studyFirstSubmitDate': '2016-07-23', 'studyFirstSubmitQcDate': '2016-07-23', 'lastUpdatePostDateStruct': {'date': '2021-02-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-07-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Development of anti-drug antibody to CT-P13', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Change of drug trough concentration', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['inflammatory bowel disease', 'biosimilar', 'anti-drug antibody', 'trough drug concentration'], 'conditions': ['Inflammatory Bowel Disease', 'Ulcerative Colitis', "Crohn's Disease"]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the development of anti-drug antibody to biosimilar CT-P13 and to assess the change of drug concentration for 1 year in patients with moderately to severe inflammatory bowel disease.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with moderate to severe inflammatory bowel disease who need to receive biosimilar CT-P13', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Clinical diagnosis of Crohn's disease or ulcerative colitis\n\nExclusion Criteria:\n\n* Tuberculosis infection\n* Allergy to CT-P13"}, 'identificationModule': {'nctId': 'NCT02846961', 'acronym': 'OACIS', 'briefTitle': 'Anti CT-P13 Antibody in Moderate to Severe Inflammatory Bowel Disease', 'organization': {'class': 'OTHER', 'fullName': 'Kyungpook National University Hospital'}, 'officialTitle': 'Occurrence of Anti-drug Antibody and Change of Drug Level for 1 Year After CT-P13 Therapy and Their Impact on Clinical Outcomes in Moderate to Severe Inflammatory Bowel Disease (OACIS Study)', 'orgStudyIdInfo': {'id': 'KMU160306'}}, 'armsInterventionsModule': {'armGroups': [{'label': "Crohn's disease", 'description': "Patients with moderate to severe Crohn's disease who need to get a biosimilar CT-P13"}, {'label': 'Ulcerative colitis', 'description': 'Patients with moderate to severe ulcerative colitis who need to get a biosimilar CT-P13'}]}, 'contactsLocationsModule': {'locations': [{'zip': '41944', 'city': 'Daegu', 'country': 'South Korea', 'facility': 'Kyungpook National University Hospital', 'geoPoint': {'lat': 35.87028, 'lon': 128.59111}}], 'overallOfficials': [{'name': 'Dong Il Park, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Sungkyunkwan University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kyungpook National University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Eun Soo Kim, MD, PhD', 'investigatorAffiliation': 'Kyungpook National University Hospital'}}}}