<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03043677</url>
  </required_header>
  <id_info>
    <org_study_id>JPG-VED-2016-01</org_study_id>
    <nct_id>NCT03043677</nct_id>
  </id_info>
  <brief_title>Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells</brief_title>
  <official_title>Ex-vivo Modulatory Effect of Biological Drugs for Inflammatory Bowel Disease on the Mucosa and on Peripheral Blood Mononuclear Cells</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      To characterize circulating DC subsets from healthy controls and IBD patients and to assess,&#xD;
      following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and&#xD;
      golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab) immunomodulators&#xD;
      on both the GI production of soluble immune mediators and the mucosal capacity to alter the&#xD;
      recruitment capacity of circulating DC subsets. It is expected that such approach will&#xD;
      provide further information on the action mechanisms of such therapies on IBD patients,&#xD;
      allowing a better understanding of the pathophysiology of this disease and the identification&#xD;
      of tissue-specific therapeutic targets, thus avoiding collateral problems associated with&#xD;
      systemic immunomodulation.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2016</start_date>
  <completion_date type="Actual">May 30, 2018</completion_date>
  <primary_completion_date type="Actual">December 31, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Effect of biological drugs on the secretion of gut-chemoattractants by the intestinal mucosa</measure>
    <time_frame>18 months</time_frame>
    <description>To assess, ex-vivo, the capacity of the IBD mucosa to recruit subsets of circulating leukocytes following mucosal conditioning with biological drugs.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">45</enrollment>
  <condition>Inflammatory Bowel Disease</condition>
  <arm_group>
    <arm_group_label>Non-inflamed</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>Inflamed ulcerative colitis</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>inflamed Crohn´s disease</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab</intervention_name>
    <description>Ex-vivo conditioning of lamina propria and peripheral blood mononuclear cells.&#xD;
Here, we will address whether the current available biological therapies for IBD patients (infliximab, golimumab, adalimumab, vedolizumab and ustekinumab) elicit a differential effect on the mucosal capacity to recruit circulating leukocytes on an ex-vivo approach using transwell culture systems.</description>
    <arm_group_label>Inflamed ulcerative colitis</arm_group_label>
    <arm_group_label>Non-inflamed</arm_group_label>
    <arm_group_label>inflamed Crohn´s disease</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Cell culture supernatants&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        healthy controls and patients with active inflammatory bowel disease (ulcerative colitis&#xD;
        and Crohn´s disease).&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients with active IBD, and endoscopic and histological diagnosis of CD or UC that attend&#xD;
        a colonoscopy with sedation performed by medical criteria.&#xD;
&#xD;
        Patients without an IBD diagnosis, or other types of inflammatory, allergic, malignant or&#xD;
        autoimmune diseases, prior to their inclusion in this project. All patients will attend a&#xD;
        colonoscopy with sedation at medical judgment with biopsy indication for histopathological&#xD;
        study as in cases of diarrhea but also due to changes in the bowel transit, rectal bleeding&#xD;
        or screening for gastrointestinal diseases. Patients will be paired in age and gender with&#xD;
        the IBD groups. All patients will have no signs of macroscopic or microscopic inflammation&#xD;
        hence excluding the presence of microscopic colitis.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Age less than 18 years&#xD;
&#xD;
          2. Chronic disease or any other advanced clinically significant pathology, uncontrolled&#xD;
             by investigator judgment.&#xD;
&#xD;
          3. Should be with medication, this will be unchanged in the 3 months prior to&#xD;
             colonoscopy.&#xD;
&#xD;
          4. Alcohol or drugs.&#xD;
&#xD;
          5. Pregnancy or lactation&#xD;
&#xD;
          6. Do not sign the informed consent form (see &quot;Ethical Issues&quot;) In any case NO&#xD;
             colonoscopies exclusively targeted for sampling for this project will be made&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 2, 2017</study_first_submitted>
  <study_first_submitted_qc>February 3, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">February 6, 2017</study_first_posted>
  <last_update_submitted>February 21, 2019</last_update_submitted>
  <last_update_submitted_qc>February 21, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 25, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Fundación de Investigación Biomédica - Hospital Universitario de La Princesa</investigator_affiliation>
    <investigator_full_name>Javier P. Gisbert</investigator_full_name>
    <investigator_title>PhD, MD</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Intestinal Diseases</mesh_term>
    <mesh_term>Inflammatory Bowel Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Adalimumab</mesh_term>
    <mesh_term>Infliximab</mesh_term>
    <mesh_term>Golimumab</mesh_term>
    <mesh_term>Ustekinumab</mesh_term>
    <mesh_term>Vedolizumab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03043677
org study id: JPG-VED-2016-01
nct id: NCT03043677
lead sponsor: 
has dmc: No
is fda regulated drug: Yes
is fda regulated device: No
To characterize circulating DC subsets from healthy controls and IBD patients and to assess,
      following an ex vivo challenge, the effect of anti-TNF (infliximab, adalimumab and
      golimumab), anti-p40 -IL-12/IL-23- (ustekinumab) and anti-α4β7 (vedolizumab) immunomodulators
      on both the GI production of soluble immune mediators and the mucosal capacity to alter the
      recruitment capacity of circulating DC subsets. It is expected that such approach will
      provide further information on the action mechanisms of such therapies on IBD patients,
      allowing a better understanding of the pathophysiology of this disease and the identification
      of tissue-specific therapeutic targets, thus avoiding collateral problems associated with
      systemic immunomodulation.
observational model: Case-Control
time perspective: Prospective
measure: Effect of biological drugs on the secretion of gut-chemoattractants by the intestinal mucosa
time frame: 18 months
description: To assess, ex-vivo, the capacity of the IBD mucosa to recruit subsets of circulating leukocytes following mucosal conditioning with biological drugs.
arm group label: Non-inflamed
arm group label: Inflamed ulcerative colitis
arm group label: inflamed Crohn´s disease
intervention type: Biological
intervention name: Ex-vivo stimulation of cells with infliximab, golimumab, adalimumab, vedolizumab and ustekinumab
description: Ex-vivo conditioning of lamina propria and peripheral blood mononuclear cells.
Here, we will address whether the current available biological therapies for IBD patients (infliximab, golimumab, adalimumab, vedolizumab and ustekinumab) elicit a differential effect on the mucosal capacity to recruit circulating leukocytes on an ex-vivo approach using transwell culture systems.
arm group label: Inflamed ulcerative colitis
arm group label: Non-inflamed
arm group label: inflamed Crohn´s disease
Cell culture supernatants
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Fundación de Investigación Biomédica - Hospital Universitario de La Princesa
investigator full name: Javier P. Gisbert
investigator title: PhD, MD
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases
mesh term: Adalimumab
mesh term: Infliximab
mesh term: Golimumab
mesh term: Ustekinumab
mesh term: Vedolizumab
sharing ipd: No