Ignite Creation Date:
2025-12-24 @ 6:35 PM
Ignite Modification Date:
2026-02-20 @ 10:57 PM
Study NCT ID:
NCT02771457
Status:
WITHDRAWN
Last Update Posted:
2016-06-30
First Post:
2016-05-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Managing Infliximab Reinduction After Temporary Discontinuation of Drug
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': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2016-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-06', 'completionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-06-29', 'studyFirstSubmitDate': '2016-05-09', 'studyFirstSubmitQcDate': '2016-05-10', 'lastUpdatePostDateStruct': {'date': '2016-06-30', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Failure Rate', 'timeFrame': 'One year', 'description': 'Defined by the number of patients who discontinued or are adjusting their dosage of Infliximab.'}], 'secondaryOutcomes': [{'measure': 'Short-term clinical response', 'timeFrame': 'One year', 'description': 'The physician will determine the presence or absence of IBD (Inflammatory Bowel Disease) using his clinical judgement based on clinical disease indices and serum inflammatory biomarkers.'}, {'measure': 'Long-term clinical response', 'timeFrame': 'One year', 'description': 'The physician will determine the presence or absence of IBD (Inflammatory Bowel Disease) using his clinical judgement based on clinical disease indices and serum inflammatory biomarkers.'}, {'measure': 'Short-term changes in patient Quality of Life', 'timeFrame': 'One Year', 'description': 'This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)'}, {'measure': 'Long-term changes in patient Quality of Life', 'timeFrame': 'One Year', 'description': 'This will be measured by the Short Inflammatory Bowel Disease Questionnaire (SIBDQ)'}, {'measure': 'Fecal calprotectin measurements', 'timeFrame': 'One year', 'description': 'This will be measured by ELISA kits'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Influximab', 'IFX', 'Remicade'], 'conditions': ['Inflammatory Bowel Disease']}, 'descriptionModule': {'briefSummary': "The primary purpose of the project is to determine what is the best schedule for restarting infliximab in patients with inflammatory bowel disease (IBD) specifically ulcerative colitis and Crohn's disease, who have undergone infliximab infusions before. The primary endpoint would be the failure rate; the need to discontinue infliximab or change treatment. A secondary aim will be to determine if infliximab drug and antibody levels can predict clinical outcomes at 1 year. Other secondary outcomes include comparing short-term and long-term steroid free remission rate, and serum and fecal inflammatory markers in response to infliximab."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Subjects 18 years or older who are willing and able to provide informed consent\n* HIstory of IBD (Crohn's disease, ulcerative colitis, indeterminate colitis) by standard clinical, histological, and radiographic date.\n* History of stable clinical response to prior IFX induction and regular maintenance dosing, as determine by enrolling clinician.\n* Prior to drug holiday, was on stable dose of infliximab for at least 3 infusions at regular maintenance intervals\n* Infliximab drug holiday for at least 12 weeks.\n\nExclusion Criteria:\n\n* Inability or unwillingness to provide informed consent\n* Pregnant patients\n* Prior history of serious infusion reaction to IFX"}, 'identificationModule': {'nctId': 'NCT02771457', 'briefTitle': 'Managing Infliximab Reinduction After Temporary Discontinuation of Drug', 'organization': {'class': 'OTHER', 'fullName': 'NYU Langone Health'}, 'officialTitle': 'Managing Infliximab Reinduction After Temporary Discontinuation of Drug', 'orgStudyIdInfo': {'id': '15-01180'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Infliximab at weeks 0,2, and 6', 'description': 'In this arm subjects will receive re-induction treatment of infliximab at weeks 0,2, and 6.', 'interventionNames': ['Drug: Infliximab at weeks 0,2, and 6']}, {'type': 'EXPERIMENTAL', 'label': 'Infliximab at weeks 0,4, and 8', 'description': 'In this arm subjects will receive re-induction treatment of infliximab at weeks 0, 4, and 8', 'interventionNames': ['Drug: Infliximab at weeks 0,4, and 8']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Infliximab at weeks 0, and 8', 'description': 'In this arm subjects will not be randomized. They will receive re-induction therapy weeks 0 and 8.', 'interventionNames': ['Drug: Infliximab at weeks 0 and 8']}], 'interventions': [{'name': 'Infliximab at weeks 0,2, and 6', 'type': 'DRUG', 'armGroupLabels': ['Infliximab at weeks 0,2, and 6']}, {'name': 'Infliximab at weeks 0,4, and 8', 'type': 'DRUG', 'armGroupLabels': ['Infliximab at weeks 0,4, and 8']}, {'name': 'Infliximab at weeks 0 and 8', 'type': 'DRUG', 'description': 'For physicians who do not feel comfortable enrolling patients in a randomized trial of infliximab re-induction they will have the option of enrolling their patients in an arm that resumes maintenance therapy only instead at 0 and 8 weeks.', 'armGroupLabels': ['Infliximab at weeks 0, and 8']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Lea Chen', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'NYU Langone Health'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'NYU Langone Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}