<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/NCT03248024</url>
  </required_header>
  <id_info>
    <org_study_id>FECPEC MICI</org_study_id>
    <nct_id>NCT03248024</nct_id>
  </id_info>
  <brief_title>An Explanatory Factors Analysis of Inflammatory Bowel Diseases(IBD's) Management Costs for Adults Patients Treated by Biotherapy and Followed at Nancy University Hospital</brief_title>
  <acronym>FECPEC MICI</acronym>
  <official_title>Etude Des Facteurs Explicatifs Des Coûts de la Prise En Charge Des Patients Adultes Atteints d'Une MICI Suivis au CHRU de Nancy et traités Par biothérapie</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Central Hospital, Nancy, France</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>HEVA - Lyon</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Central Hospital, Nancy, France</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to analyze the factors influencing the medical and non-medical&#xD;
      direct costs of patients treated with biotherapy during the last twelve months (infliximab or&#xD;
      adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for&#xD;
      treating Crohn's desease or ulcerative colitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 28, 2016</start_date>
  <completion_date type="Actual">February 7, 2017</completion_date>
  <primary_completion_date type="Actual">February 7, 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Retrospective health care consumption</measure>
    <time_frame>one year</time_frame>
    <description>Desease treatment cost individual level data</description>
  </primary_outcome>
  <enrollment type="Actual">119</enrollment>
  <condition>Inflammatory Bowel Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patients who received biotherapy during the last 12 months preceeding consultation for&#xD;
        treatment of crohn's disease or ulcerative colitis.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients consulted at the Gastroenterology services of Nancy University Hospital&#xD;
             during the period of inclusion&#xD;
&#xD;
          2. Patients over 18 of age the day of consultation&#xD;
&#xD;
          3. Patients treated at least one time by biotherapy during the last 12 months preceeding&#xD;
             inclusion&#xD;
&#xD;
          4. Patients with crohn's disease or ulcerative colitis.&#xD;
&#xD;
          5. Patients accepting to respond to the questionnary&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Age under 18 years , the day of consultation&#xD;
&#xD;
          -  Patient that not accept or unable to complete the retrospective questionnary&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>July 2017</verification_date>
  <study_first_submitted>August 9, 2017</study_first_submitted>
  <study_first_submitted_qc>August 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 14, 2017</study_first_posted>
  <last_update_submitted>August 9, 2017</last_update_submitted>
  <last_update_submitted_qc>August 9, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 14, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Chronic Disease</keyword>
  <keyword>Ulcerative Colitis</keyword>
  <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>
  <!-- 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/NCT03248024
org study id: FECPEC MICI
nct id: NCT03248024
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The objective of this study is to analyze the factors influencing the medical and non-medical
      direct costs of patients treated with biotherapy during the last twelve months (infliximab or
      adalimumab), including biosimilars (infliximab biosimilars: Inflectra ™ and Remsima ™) for
      treating Crohn's desease or ulcerative colitis
observational model: Cohort
time perspective: Retrospective
measure: Retrospective health care consumption
time frame: one year
description: Desease treatment cost individual level data
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Intestinal Diseases
mesh term: Inflammatory Bowel Diseases