Early Biomarkers in Circulating α 4β7 + T Cells to Predict Response to Vedolizumab in Inflamatory Bowel Disease Patients.
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|ClinicalTrials.gov Identifier: NCT02712866|
Recruitment Status : Unknown
Verified June 2016 by Lucia Marquez, Parc de Salut Mar.
Recruitment status was: Not yet recruiting
First Posted : March 18, 2016
Last Update Posted : June 6, 2016
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.
Objective: 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.
Methods: 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).
Epidemiological 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.
At week 14 response to the treatment will be evaluated by ileocolonoscopy or enteroMRI.
Peripheral 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).
Blood lymphocytes will be isolated and multicolor flow cytometry will be performed on stored circulating memory T cells.
Percentage 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.
|Condition or disease||Intervention/treatment|
|Inflammatory Bowel Disease||Drug: Vedolizumab|
|Study Type :||Observational|
|Estimated Enrollment :||24 participants|
|Official Title:||EARLY BIOMARKERS IN CIRCULATING α 4β7+ T CELLS TO PREDICT RESPONSE TO VEDOLIZUMAB IN INFLAMMATORY BOWEL DISEASE PATIENTS|
|Study Start Date :||July 2016|
|Estimated Primary Completion Date :||July 2017|
|Estimated Study Completion Date :||December 2017|
|Patients treated with vedolizumab||
Administration of intravenous Vedolizumab in inflammatory bowel disease patients
- Surface and Th17 phenotype markers in T lymphocytes as response predictors [ Time Frame: From drug administration until 14 weeks. ]
- Surface and Th17 phenotype markers in T lymphocytes as sustained remission predictors [ Time Frame: From drug administration (week 14th) until 12 months. ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02712866
|Contact: Lucía Márquez Mosquera, MD, PhDemail@example.com|
|Hospital del Mar||Not yet recruiting|
|Barcelona, Spain, 08003|
|Contact: Lucia Márquez Mosquera, MD, PhD 0034625910982 firstname.lastname@example.org|