Ignite Creation Date:
2025-12-24 @ 9:46 PM
Ignite Modification Date:
2026-01-04 @ 4:41 PM
Study NCT ID:
NCT02862132
Status:
COMPLETED
Last Update Posted:
2022-10-25
First Post:
2016-07-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Finland']}, '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543529', 'term': 'vedolizumab'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 142}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-10', 'completionDateStruct': {'date': '2022-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-10-24', 'studyFirstSubmitDate': '2016-07-31', 'studyFirstSubmitQcDate': '2016-08-04', 'lastUpdatePostDateStruct': {'date': '2022-10-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2022-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Complete remission at week 14', 'timeFrame': 'weeks 14', 'description': "As defined by all three criteria:\n\ni. Steroids and Exclusive enteral nutrition (EEN) (defined as \\>50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \\<12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) \\<10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)"}, {'measure': 'Complete remission at week 30', 'timeFrame': 'weeks 30', 'description': "As defined by all three criteria:\n\ni. Steroids and Exclusive enteral nutrition (EEN) (defined as \\>50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \\<12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) \\<10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)"}, {'measure': 'Complete remission at week 54', 'timeFrame': 'weeks 54', 'description': "As defined by all three criteria:\n\ni. Steroids and Exclusive enteral nutrition (EEN) (defined as \\>50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \\<12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) \\<10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)"}, {'measure': 'Complete remission at week 108', 'timeFrame': 'weeks 108', 'description': "As defined by all three criteria:\n\ni. Steroids and Exclusive enteral nutrition (EEN) (defined as \\>50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \\<12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) \\<10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)"}, {'measure': 'Complete remission at week 162', 'timeFrame': 'weeks 162', 'description': "As defined by all three criteria:\n\ni. Steroids and Exclusive enteral nutrition (EEN) (defined as \\>50% of daily calories with enteral nutrition)- free ii. Clinical remission (i.e. weighted Pediatric Crohn's Disease Activity Index (wPCDAI) \\<12.5 points in CD, and Paediatric Ulcerative Colitis Activity Index (PUCAI) \\<10 in UC) iii. CRP lower than 1.5 times upper normal limit (UNL) (may be substituted by Erythocytes Sedimentation Rate (ESR) if CRP missing)"}], 'secondaryOutcomes': [{'measure': 'Steroid and EEN free clinical remission (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list.', 'timeFrame': 'week 30, week 54, week 108, week 162'}, {'measure': 'Steroid and EEN free clinical response (without the need for normal CRP) using PCDAI or PUCAI score and concomitant medication list.', 'timeFrame': 'week 30, week 54, week 108, week 162'}, {'measure': 'Fecal calprotectin levels', 'timeFrame': 'week 30, week 54, week 108, week 162', 'description': 'Levels of calprotectin will be measured in the lab using calprotectin kit.'}, {'measure': 'serum CRP levels', 'timeFrame': 'week 30, week 54, week 108, week 162', 'description': 'CRP levels will be measured in the lab'}, {'measure': 'Rate of loss of response including drug levels', 'timeFrame': 'week 30, week 54, week 108, week 162'}, {'measure': 'Steroid dependency (defined as cumulative use of >4 months in a year with at least one need to increase dose while weaning)', 'timeFrame': 'week 30, week 54, week 108, week 162'}, {'measure': 'Adverse events', 'timeFrame': 'week 30, week 54, week 108, week 162'}, {'measure': 'Measures of mucosal inflammation as available as part of clinical care using endoscopy, imaging or capsule endoscopy.', 'timeFrame': 'week 30, week 54, week 108, week 162'}, {'measure': 'Time to induction of remission', 'timeFrame': 'week 30, week 54, week 108, week 162'}, {'measure': 'Longitudinal Physician Global Assessment (PGA)', 'timeFrame': 'week 30, week 54, week 108, week 162', 'description': 'PGA will be measured using Visual analogue scale (VAS)'}, {'measure': 'Height velocity as compared with the year prior to commencing VDZ', 'timeFrame': 'week 30, week 54, week 108, week 162'}, {'measure': 'Need for surgical interventions (including resections, colectomy, and dilatations)', 'timeFrame': 'week 30, week 54, week 108, week 162'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['VDZ: Vedolizumab', 'UC: Ulcerative colitis', "CD: Crohn's disease", 'TDM: Therapeutic drug monitoring'], 'conditions': ["Crohn's Disease", 'Ulcerative Colitis', 'Inflammatory Bowel Disease']}, 'referencesModule': {'references': [{'pmid': '41251034', 'type': 'DERIVED', 'citation': "D'Arcangelo G, Turner D, Ledder O, Orlanski-Meyer E, Broide E, Granot M, Matar M, Hussey S, Yerushalmy-Feler A, Norden C, Miele E, Aloi M. Vedolizumab for extraintestinal manifestations in pediatric inflammatory bowel disease: Results from the VedoKids study. J Pediatr Gastroenterol Nutr. 2025 Nov 18. doi: 10.1002/jpn3.70276. Online ahead of print."}, {'pmid': '39788134', 'type': 'DERIVED', 'citation': 'Atia O, Shavit-Brunschwig Z, Lev-Tzion R, Stein R, Broide E, Urlep D, Hyams J, Weiss B, Aloi M, Assa A, Gerasimidis K, Nichols B, Russell RK, Turner D. Maintenance treatment with vedolizumab in paediatric inflammatory bowel disease (VEDOKIDS): 54-week outcomes of a multicentre, prospective, cohort study. Lancet Gastroenterol Hepatol. 2025 Mar;10(3):234-247. doi: 10.1016/S2468-1253(24)00319-4. Epub 2025 Jan 6.'}, {'pmid': '36306803', 'type': 'DERIVED', 'citation': 'Atia O, Shavit-Brunschwig Z, Mould DR, Stein R, Matar M, Aloi M, Ledder O, Focht G, Urlep D, Hyams J, Broide E, Weiss B, Levine J, Russell RK, Turner D. Outcomes, dosing, and predictors of vedolizumab treatment in children with inflammatory bowel disease (VEDOKIDS): a prospective, multicentre cohort study. Lancet Gastroenterol Hepatol. 2023 Jan;8(1):31-42. doi: 10.1016/S2468-1253(22)00307-7. Epub 2022 Oct 26.'}]}, 'descriptionModule': {'briefSummary': "Vedolizumab (VDZ) is a humanized immunoglobulin G1 monoclonal antibody acting against α4β7 integrin which modulates lymphocyte trafficking in the gut.\n\nResults from the adult GEMINI-1 and GEMINI-2 trials demonstrated clinical efficacy in induction and maintenance of remission in both ulcerative colitis (UC) and Crohn's disease (CD), respectively.\n\nRecent real life cohorts in adults support the effectiveness of VDZ in inducing and maintaining remission, both in CD and UC. In pediatrics, there are very limited data on the use of VDZ besides two retrospective case series.\n\nData on immunogenicity and therapeutic drug monitoring (TDM) of VDZ is conflicting in adults and practically non-existent in children.\n\nThe investigators aim to prospectively explore the real life short and longer term outcomes of VDZ in pediatric IBD (including growth) and to develop a prediction model for treatment success based on VDZ trough levels and other clinical and laboratory variables.", 'detailedDescription': 'This is a multi-center prospective cohort study in which the investigators are aim to enroll 140 children under the age of 18 years, diagnosed with CD, inflammatory bowel disease unclassified (IBDU) or UC (approximately 70 in UC/IBDU and 70 in the CD group) who commenced on Vedolizumab for any reason at the discretion of the treating physician.\n\nPatients will be followed up to 3 years at 8 different time points: week 0, week 2, week 6, week 14, week 30, week 54 (1 year), week 108 (2 years) and week 162 (3 years). Blood work will be collected at each visit during the time of venous access insertion for the drug infusion for serum and stool sample will be collected at visits 0, 14, 30, and 54. In addition, at week 0 and 14 whole blood will be collected into a PaxGene tube for gene expression analysis.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Children under the age of 18 years.\n2. IBD Diagnosis\n3. Initiating Vedolizumab therapy\n\nExclusion Criteria:\n\n1\\. Starting Vedolizumab to prevent post operative recurrence'}, 'identificationModule': {'nctId': 'NCT02862132', 'briefTitle': 'Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Shaare Zedek Medical Center'}, 'officialTitle': 'Predicting Response to Vedolizumab in Pediatric Inflammatory Bowel Diseases (IBD) Including Drug Levels: a Multi-center Prospective Cohort Study, From the Pediatric IBD Porto Group of European Society for Paediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN)', 'orgStudyIdInfo': {'id': 'VEDOKIDS'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vedolizumab', 'description': 'IV Vedolizumab 177mg/m2 Body Surface Area (BSA), max. 300mg Induction regimen: 0,2,6 and then every 8 weeks', 'interventionNames': ['Drug: Vedolizumab']}], 'interventions': [{'name': 'Vedolizumab', 'type': 'DRUG', 'otherNames': ['Entyvio'], 'armGroupLabels': ['Vedolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '06032', 'city': 'Hartford', 'state': 'Connecticut', 'country': 'United States', 'facility': "Connecticut Children's Medical Center", 'geoPoint': {'lat': 41.76371, 'lon': -72.68509}}, {'city': 'Morristown', 'state': 'New Jersey', 'country': 'United States', 'facility': "Atlantic Children's Health-Goryeb Children's Hospital", 'geoPoint': {'lat': 40.79677, 'lon': -74.48154}}, {'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': "Cohen Children's Medical Center of NY, Northwell", 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': "Children's Hospital of Philadelphia", 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Hvidovre University Hospital', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Dublin', 'country': 'Ireland', 'facility': "Our Lady's Children's Hospital Crumlin", 'geoPoint': {'lat': 53.33306, 'lon': -6.24889}}, {'city': 'Haifa', 'country': 'Israel', 'facility': 'Rambam Medical Cener', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Holon', 'country': 'Israel', 'facility': 'Wolfson Medical Center', 'geoPoint': {'lat': 32.01034, 'lon': 34.77918}}, {'city': 'Jerusalem', 'country': 'Israel', 'facility': 'Shaare Zedek Medical Center', 'geoPoint': {'lat': 31.76904, 'lon': 35.21633}}, {'city': 'Petah Tikva', 'country': 'Israel', 'facility': 'Schneider Medical Center', 'geoPoint': {'lat': 32.08707, 'lon': 34.88747}}, {'city': 'Ramat Gan', 'country': 'Israel', 'facility': 'Sheba Medical Center', 'geoPoint': {'lat': 32.08227, 'lon': 34.81065}}, {'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Ichilov', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}, {'city': 'Tzrifin', 'country': 'Israel', 'facility': 'Assaf Harofeh', 'geoPoint': {'lat': 31.95649, 'lon': 34.84002}}, {'city': 'Ljubljana', 'country': 'Slovenia', 'facility': "University Children's Hospital Ljubljana", 'geoPoint': {'lat': 46.05108, 'lon': 14.50513}}, {'city': 'Glasgow', 'country': 'United Kingdom', 'facility': 'The Royal Hospital for Children Glasgow', 'geoPoint': {'lat': 55.86515, 'lon': -4.25763}}], 'overallOfficials': [{'name': 'Dan Turner, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Shaare Zedek Medical Center'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shaare Zedek Medical Center', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head, The Juliet Keidan Institute of Pediatric Gastroenterology, Hepatology and Nutrition, Shaare Zedek Medical Center, Jerusalem, Israel', 'investigatorFullName': 'Dr Dan Turner', 'investigatorAffiliation': 'Shaare Zedek Medical Center'}}}}