Ignite Creation Date:
2025-12-24 @ 4:18 PM
Ignite Modification Date:
2026-02-18 @ 1:02 AM
Study NCT ID:
NCT02712866
Status:
COMPLETED
Last Update Posted:
2019-02-28
First Post:
2016-03-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Biomarkers in Circulating α 4β7 + T Cells to Predict Response to Vedolizumab in Inflamatory Bowel Disease Patients.
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C543529', 'term': 'vedolizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 24}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-26', 'studyFirstSubmitDate': '2016-03-14', 'studyFirstSubmitQcDate': '2016-03-14', 'lastUpdatePostDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-03-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Surface and Th17 phenotype markers in T lymphocytes as response predictors', 'timeFrame': 'From drug administration until 14 weeks.'}], 'secondaryOutcomes': [{'measure': 'Surface and Th17 phenotype markers in T lymphocytes as sustained remission predictors', 'timeFrame': 'From drug administration (week 14th) until 12 months.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Inflammatory Bowel Disease']}, 'descriptionModule': {'briefSummary': "Background: Infiltration of GI by T lymphocytes is a pathogenic mechanism both in ulcerative colitis (UC) and in Crohn's disease (CD). Vedolizumab (VDZ) is a humanized monoclonal antibody binding with high affinity to α4β7 integrin blocking α4β7+-MAdCAM-1 interaction, hence blocking a key step in GI lymphocytes T infiltration. VDZ has demonstrated a therapeutic effect in UC and CD. Investigators still lack of adequate biomarkers to predict clinical response to biological treatments, specially avoiding invasive procedures.\n\nObjective: Study whether circulating CD4+ and CD8+ α4β7+ memory T lymphocytes and some of their surface markers might be molecular markers of response to VDZ treatment in patients with UC and CD.\n\nMethods: Prospective (pilot) study including 24 adult IBD patients (12 UC patients and 12 CD patients (patients with fistulizing perianal disease will be excluded) with active disease and prior failure to anti-TNFα treatments starting treatment with VDZ. They will received VDZ in standard induction (300mg intravenously, 0-2-6 weeks) and maintenance schemes (300mg intravenously, every 8 weeks).\n\nEpidemiological and clinical data from every patient will be recorded prospectively. Disease activity at weeks 0, 2, 6 and 14 weeks will be evaluated through validated clinical scores, biological parameters and fecal biomarkers.\n\nAt week 14 response to the treatment will be evaluated by ileocolonoscopy or enteroMRI.\n\nPeripheral blood will be obtained from every patient at baseline, before the third infusion of VDZ (6th week) and before the first maintenance dose (14th week).\n\nBlood lymphocytes will be isolated and multicolor flow cytometry will be performed on stored circulating memory T cells.\n\nPercentage and absolute values of circulating CD4+ and CD8+ α4β7+ memory T lymphocytes as well as several surface markers related to their activation state (HLA-DR, CD25), Th17 phenotype (IL23R, CCR6, intracellular IL17A) and Th1 phenotype (INFγ)will be assessed on α4β7+ memory T cells."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '24 adults with inflammatory bowel disease (12 Ulcerative colitis patients and 12 Chron Disease patients with active disease and prior failure to anti-TNFα treatments (inadequate response, loss of response, intolerance), starting treatment with Vedolizumab.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Ulcerative colitis or Crohn's disease diagnosis established by Lennard-Jones criteria\n* Clinically active disease confirmed by endoscopic or radiologic criteria Magnetic Resonance Image (MRI)\n* \\>18 years of age\n* Intolerant, refractory or secondary loss of response to anti-Anti-tumour necrosis factor (TNF) alfa treatment.\n\nExclusion Criteria:\n\n* Crohn's disease with perianal disease\n* Active Tuberculosis\n* Current infections (including Clostridium difficile and Cytomegalovirus)\n* History of cancer, including hematologic malignancy and solid tumours within 5 years before\n* History of demyelinating disease\n* Pregnancy or breastfeeding"}, 'identificationModule': {'nctId': 'NCT02712866', 'briefTitle': 'Early Biomarkers in Circulating α 4β7 + T Cells to Predict Response to Vedolizumab in Inflamatory Bowel Disease Patients.', 'organization': {'class': 'OTHER', 'fullName': 'Parc de Salut Mar'}, 'officialTitle': 'EARLY BIOMARKERS IN CIRCULATING α 4β7+ T CELLS TO PREDICT RESPONSE TO VEDOLIZUMAB IN INFLAMMATORY BOWEL DISEASE PATIENTS', 'orgStudyIdInfo': {'id': 'FIM-VED-2016-01'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients treated with vedolizumab', 'interventionNames': ['Drug: Vedolizumab']}], 'interventions': [{'name': 'Vedolizumab', 'type': 'DRUG', 'description': 'Administration of intravenous Vedolizumab in inflammatory bowel disease patients', 'armGroupLabels': ['Patients treated with vedolizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08003', 'city': 'Barcelona', 'country': 'Spain', 'facility': 'Hospital del Mar', 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Parc de Salut Mar', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Lucia Marquez', 'investigatorAffiliation': 'Parc de Salut Mar'}}}}