<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/NCT01661257</url>
  </required_header>
  <id_info>
    <org_study_id>2009-10-038-002</org_study_id>
    <nct_id>NCT01661257</nct_id>
  </id_info>
  <brief_title>Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy</brief_title>
  <official_title>Expression of T-cell Immunoglobulin- and Mucin-domain-containing Molecule 3 (TIM-3)and Correlation With Disease Activity in Pediatric Crohn's Disease With Anti TNF-α Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Samsung Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Samsung Medical Center</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study investigated the expression of T-cell immunoglobulin- and mucin-domain-containing&#xD;
      molecule 3 (TIM-3) in the colonic mucosa and/or the peripheral blood of children with Crohn's&#xD;
      disease during anti TNF-α (infliximab) therapy.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The immunoregulatory effects of TIM-3 on patients with Crohn's disease according to the&#xD;
      treatment have not yet been investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2009</start_date>
  <completion_date type="Actual">June 2011</completion_date>
  <primary_completion_date type="Actual">June 2011</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Basic Science</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease with anti TNF-α Therapy</measure>
    <time_frame>1-year treatment period</time_frame>
    <description>Disease Activity Index (PCDAI) scores, Peripheral blood for TIM-3 mRNA expression</description>
  </primary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Crohn's Disease</condition>
  <arm_group>
    <arm_group_label>TIM-3</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3) is a novel transmembrane protein that is involved in the regulation of Th1-cell-mediated immunity.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Infliximab</intervention_name>
    <arm_group_label>TIM-3</arm_group_label>
    <other_name>Remicade</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  •Pediatric patients who were diagnosed with severe Crohn's disease who require&#xD;
             infliximab treatment&#xD;
&#xD;
               -  confirmed diagnostic of Crohn's disease in clinical, endoscopic and histological&#xD;
                  findings&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  •patients who has proven to have infliximab antibody&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Samsung Medical Center</name>
      <address>
        <city>Seoul</city>
        <zip>135-710</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 7, 2012</study_first_submitted>
  <study_first_submitted_qc>August 7, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 9, 2012</study_first_posted>
  <last_update_submitted>August 7, 2012</last_update_submitted>
  <last_update_submitted_qc>August 7, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 9, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Samsung Medical Center</investigator_affiliation>
    <investigator_full_name>YonHo Choe</investigator_full_name>
    <investigator_title>Pediatrics</investigator_title>
  </responsible_party>
  <keyword>Crohn's disease</keyword>
  <keyword>Infliximab</keyword>
  <keyword>T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3)</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Crohn Disease</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infliximab</mesh_term>
  </intervention_browse>
  <!-- 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/NCT01661257
org study id: 2009-10-038-002
nct id: NCT01661257
lead sponsor: 
has dmc: Yes
This study investigated the expression of T-cell immunoglobulin- and mucin-domain-containing
      molecule 3 (TIM-3) in the colonic mucosa and/or the peripheral blood of children with Crohn's
      disease during anti TNF-α (infliximab) therapy.
The immunoregulatory effects of TIM-3 on patients with Crohn's disease according to the
      treatment have not yet been investigated.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Basic Science
masking: None (Open Label)
measure: Expression of TIM-3 and Correlation With Disease Activity in Pediatric Crohn's Disease with anti TNF-α Therapy
time frame: 1-year treatment period
description: Disease Activity Index (PCDAI) scores, Peripheral blood for TIM-3 mRNA expression
arm group label: TIM-3
arm group type: Experimental
description: T-cell immunoglobulin- and mucin-domain-containing molecule 3 (TIM-3) is a novel transmembrane protein that is involved in the regulation of Th1-cell-mediated immunity.
intervention type: Drug
intervention name: Infliximab
arm group label: TIM-3
other name: Remicade
criteria: 
gender: All
minimum age: 13 Years
maximum age: 17 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Samsung Medical Center
investigator full name: YonHo Choe
investigator title: Pediatrics
mesh term: Crohn Disease
mesh term: Infliximab