Ignite Creation Date:
2025-12-26 @ 11:13 PM
Ignite Modification Date:
2026-03-10 @ 4:54 AM
Study NCT ID:
NCT02423512
Status:
COMPLETED
Last Update Posted:
2017-09-13
First Post:
2015-04-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Impact of Anti-TNF Exposure on Vedolizumab Effectiveness
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015212', 'term': 'Inflammatory Bowel Diseases'}, {'id': 'D003424', 'term': 'Crohn Disease'}, {'id': 'D003093', 'term': 'Colitis, Ulcerative'}], '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': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Whole blood, serum, mucosal tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-09', 'completionDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-09-11', 'studyFirstSubmitDate': '2015-04-17', 'studyFirstSubmitQcDate': '2015-04-17', 'lastUpdatePostDateStruct': {'date': '2017-09-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-06-13', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'biomarker MAdCAM-1', 'timeFrame': 'baseline and week 14', 'description': 'change in biomarker MAdCAM-1 at week 14 as compared to baseline'}], 'secondaryOutcomes': [{'measure': 'biomarker alpha 4 beta 7', 'timeFrame': 'baseline and week 14', 'description': 'change in biomarker alpha 4 beta 7 at week 14 as compared to baseline'}, {'measure': 'TNF levels', 'timeFrame': 'baseline and week 14', 'description': 'change in TNF levels at week 14 as compared to baseline'}, {'measure': 'mucosal drug concentration', 'timeFrame': 'week 14', 'description': 'mucosal drug concentration in those undergoing colonoscopy'}, {'measure': 'mucosal drug concentration', 'timeFrame': 'week 30', 'description': 'mucosal drug concentration in those undergoing colonoscopy'}, {'measure': 'vedolizumab drug concentration', 'timeFrame': 'week 14', 'description': 'vedolizumab drug concentration in those patients scheduled for vedolizumab therapy'}, {'measure': 'vedolizumab drug concentration', 'timeFrame': 'week 30', 'description': 'vedolizumab drug concentration in those patients scheduled for vedolizumab therapy'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Inflammatory Bowel Diseases', 'Vedolizumab', 'Ulcerative Colitis', "Crohn's Disease", 'MADCAM1', 'integrin alpha4beta7'], 'conditions': ['Inflammatory Bowel Disease', "Crohn's Disease", 'Ulcerative Colitis']}, 'referencesModule': {'references': [{'pmid': '23964933', 'type': 'BACKGROUND', 'citation': "Sandborn WJ, Feagan BG, Rutgeerts P, Hanauer S, Colombel JF, Sands BE, Lukas M, Fedorak RN, Lee S, Bressler B, Fox I, Rosario M, Sankoh S, Xu J, Stephens K, Milch C, Parikh A; GEMINI 2 Study Group. Vedolizumab as induction and maintenance therapy for Crohn's disease. N Engl J Med. 2013 Aug 22;369(8):711-21. doi: 10.1056/NEJMoa1215739."}, {'pmid': '23964932', 'type': 'BACKGROUND', 'citation': 'Feagan BG, Rutgeerts P, Sands BE, Hanauer S, Colombel JF, Sandborn WJ, Van Assche G, Axler J, Kim HJ, Danese S, Fox I, Milch C, Sankoh S, Wyant T, Xu J, Parikh A; GEMINI 1 Study Group. Vedolizumab as induction and maintenance therapy for ulcerative colitis. N Engl J Med. 2013 Aug 22;369(8):699-710. doi: 10.1056/NEJMoa1215734.'}, {'pmid': '16267322', 'type': 'BACKGROUND', 'citation': "Sandborn WJ, Colombel JF, Enns R, Feagan BG, Hanauer SB, Lawrance IC, Panaccione R, Sanders M, Schreiber S, Targan S, van Deventer S, Goldblum R, Despain D, Hogge GS, Rutgeerts P; International Efficacy of Natalizumab as Active Crohn's Therapy (ENACT-1) Trial Group; Evaluation of Natalizumab as Continuous Therapy (ENACT-2) Trial Group. Natalizumab induction and maintenance therapy for Crohn's disease. N Engl J Med. 2005 Nov 3;353(18):1912-25. doi: 10.1056/NEJMoa043335."}, {'pmid': '24859203', 'type': 'BACKGROUND', 'citation': "Sands BE, Feagan BG, Rutgeerts P, Colombel JF, Sandborn WJ, Sy R, D'Haens G, Ben-Horin S, Xu J, Rosario M, Fox I, Parikh A, Milch C, Hanauer S. Effects of vedolizumab induction therapy for patients with Crohn's disease in whom tumor necrosis factor antagonist treatment failed. Gastroenterology. 2014 Sep;147(3):618-627.e3. doi: 10.1053/j.gastro.2014.05.008. Epub 2014 May 21."}, {'type': 'BACKGROUND', 'citation': "Arjis I, De Hertogh G, Machiels K, et al. Mucosal gene expression of cell adhesion molecules, chemokines, and chemokine receptors in patients with inflammatory bowel disease before and after infliximab treatment. American Journal of Gastroenterology. April 2011;106:748-761 Biancheri P, Di Sabatino A, Rovedatti L, et al. Effect of tumor necrosis factor-alpha blockade on mucosal addressin cell-adhesion molecule-1 in Crohn's disease. Inflammatory Bowel Disease. Feb 2013;19(2):259-264."}]}, 'descriptionModule': {'briefSummary': "Vedolizumab is a new medication being used for the treatment of Crohn's disease and Ulcerative colitis. It works by blocking specific white blood cells (alpha 4-beta7 lymphocytes) from migrating to areas of inflammation in the gastrointestinal tract. Previous studies have shown that patients who have previous exposure to another type of medication for Crohn's disease and Ulcerative colitis (anti-TNF medications) do not respond to vedolizumab as well as those who have never been exposed. This study will investigate biologic markers in the blood and tissue the help identify possible reasons for this difference.", 'detailedDescription': "Patients will be enrolled in the study when they are selected to initiate vedolizumab therapy. Vedolizumab is an intravenous infusion given at increasing intervals. The first infusion of vedolizumab will be considered baseline. Patients may be enrolled at baseline or at colonoscopy prior to the first scheduled infusion of vedolizumab (pre-treatment visit). The standard induction protocol for vedolizumab consists of infusions at week 0 (baseline), week 2, and week 6. Vedolizumab, as per standard-of-care, is then continued at an interval of every 8 weeks following induction therapy. Vedolizumab treatment will be prescribed as per standard practice and will be prescribed regardless of participation in this study. Patients will not receive medication for the sole purpose of this research. Treatment decisions including timing of wash out period between anti-TNf and vedolizumab will be made by the subject's physician and not per the research protocol. There will not be a protocolized washout period for patients previously receiving anti-TNF therapy because treatment will be standard of care and per the directing physician.\n\nStandard of care laboratory tests will be performed by the clinical laboratory at Mount Sinai Hospital. All other measurements will be completed at Prometheus Therapeutics \\& Diagnostics in San Diego, California or at a Takeda identified lab for vedolizumab concentrations and antibodies."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female adults with a diagnosis of inflammatory bowel disease who will be started on vedolizumab therapy as clinically indicated and in discussion with their treating physician will be eligible. Patients will not be started on vedolizumab for the sole purpose of this study', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male and female adults with a diagnosis of inflammatory bowel disease\n* Patients who will be started on vedolizumab therapy as clinically indicated and in discussion with their treating physician will be eligible. Patients will not be started on vedolizumab for the sole purpose of this study\n\nExclusion Criteria:\n\n-Patients with prior exposure to vedolizumab or natalizumab'}, 'identificationModule': {'nctId': 'NCT02423512', 'briefTitle': 'The Impact of Anti-TNF Exposure on Vedolizumab Effectiveness', 'organization': {'class': 'OTHER', 'fullName': 'Icahn School of Medicine at Mount Sinai'}, 'officialTitle': 'The Impact of Anti-TNF Exposure on Vedolizumab Effectiveness: A Biomarker Study.', 'orgStudyIdInfo': {'id': 'GCO 15-0651'}, 'secondaryIdInfos': [{'id': 'IISR-2015-100947', 'type': 'OTHER', 'domain': 'Takeda Pharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'Anti-TNF Exposure', 'description': 'Inflammatory Bowel Disease (IBD) patients scheduled to start vedolizumab therapy who have been previously exposed to anti-TNF therapy'}, {'label': 'anti-TNF Naive', 'description': 'IBD patients scheduled to start vedolizumab therapy who have not been previously exposed to anti-TNF therapy'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10029', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Susan and Leonard Feinstein Inflammatory Bowel Disease Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}], 'overallOfficials': [{'name': 'Marla C. Dubinsky, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Icahn School of Medicine at Mount Sinai'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Icahn School of Medicine at Mount Sinai', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}