<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/NCT04422171</url>
  </required_header>
  <id_info>
    <org_study_id>38RC19.379</org_study_id>
    <secondary_id>2020-A00494-35</secondary_id>
    <nct_id>NCT04422171</nct_id>
  </id_info>
  <brief_title>A 12-month Real Life Study of IBD Patients Switched From Adalimumab Originator Humira® to One of Its Biosimilar</brief_title>
  <acronym>Rhoneswitch</acronym>
  <official_title>A 12-month Real Life Study of IBD Patients Under Stable Steroid Free Clinical and Biological Remission Switched From Adalimumab Originator Humira® to One of Its Biosimilar: Amgevita®,Hulio®,Hyrimoz® or Imraldi®.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Grenoble</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Grenoble</source>
  <oversight_info>
    <has_dmc>No</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>
      Biosimilars represent great potential in cost saving and reinvestment opportunities in&#xD;
      healthcare. Biosimilars of adalimumab appear to be clinically equivalent to the reference&#xD;
      product in patients with rheumatoid arthritis and psoriasis. No data are currently available&#xD;
      in IBD patients. Real-life data are needed.&#xD;
&#xD;
      Minimizing the switch back is another clinical challenge in the current area of biosimilars.&#xD;
      The primary objective of Rhoneswitch is to describe the magnitude of patient's switch back&#xD;
      defined as a deterioration of symptoms without objective identification of disease activity,&#xD;
      12 months after the switch from ada originator Humira®.&#xD;
&#xD;
      The primary endpoint is to assess the percentage of patients who switch back to originator&#xD;
      therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®,&#xD;
      Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The subject will be include during usual hospital consultation after reviewing&#xD;
      inclusion/exclusion criteria and obtain non opposition. Data will be collected during 3 usual&#xD;
      hospital consultations: at month 3, month 6, and month 12. The end of study will be at month&#xD;
      12 or at premature termination.&#xD;
&#xD;
      Questionnaires will be done in addition during all usual hospital consultations.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 19, 2020</start_date>
  <completion_date type="Anticipated">January 31, 2023</completion_date>
  <primary_completion_date type="Anticipated">June 18, 2021</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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Magnitude of patient's switch back defined as a deterioration of symptoms without objective identification of disease activity, 12 months after the switch from ada originator Humira®.</measure>
    <time_frame>12 months</time_frame>
    <description>Percentage of patients who switch back to originator therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®, Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.</description>
  </primary_outcome>
  <enrollment type="Anticipated">400</enrollment>
  <condition>IBD Patients, Originator Treatment, Biosimilar, Switch Back</condition>
  <eligibility>
    <study_pop>
      <textblock>
        IBD Patients (Ulcerative Colitis and Crohn's disease) under stable (more than 3 months)&#xD;
        steroid free clinical and biological remission with adalimumab.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        INCLUSION CRITERIA&#xD;
&#xD;
          -  Documented diagnosis of CD or UC established on the basis of standard clinical,&#xD;
             endoscopic and histological criteria at least 3 months prior to inclusion.&#xD;
&#xD;
          -  Inactive CD or UC outpatients are defined per clinical assessment as an Harvey&#xD;
             Bradshaw Index (HBI) score ≤4 for CD patients and a Partial Mayo Score (PMS) ≤2 with&#xD;
             each sub-score of 1 or less for UC and/or according to ECCO classification (Sturm&#xD;
             2019) within previous 3 months, demonstrating an adequate clinical remission to ada&#xD;
             originator&#xD;
&#xD;
          -  May be receiving the following drugs (but must remain on stable dose for 10 weeks):&#xD;
&#xD;
               -  Oral 5-aminosalicylates (ASA) compounds or rectal formulations of 5ASA provided&#xD;
                  the dose to be stable at least 4 weeks before switching&#xD;
&#xD;
               -  Azathioprine, 6-MP or methotrexate provided the dose has been stable for 4 weeks&#xD;
                  prior to inclusion (dose must remain stable for 10 weeks after switching)&#xD;
&#xD;
          -  Non opposition required&#xD;
&#xD;
        EXCLUSION CRITERIA&#xD;
&#xD;
          -  Diagnosis of indeterminate colitis, ischaemic colitis, fulminant colitis&#xD;
&#xD;
          -  Current use of another TNF inhibitor included (but not limited to) infliximab,&#xD;
             certolizumab, golimumab&#xD;
&#xD;
          -  Current use of vedolizumab or ustekinumab&#xD;
&#xD;
          -  Current use of JAK inhibitors or S1P modulators&#xD;
&#xD;
          -  Current use of oral corticosteroids&#xD;
&#xD;
          -  Active flaring CD or UC patients defined as a HBI &gt; 4 for CD and a PMS&gt;1 for UC and/or&#xD;
             concomitant CS medication&#xD;
&#xD;
          -  Pregnancy or breast feeding&#xD;
&#xD;
          -  Subject under guardianship or subject deprived of liberty&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>75 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Nicolas Mathieu</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Grenoble Alpes</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>NICOLAS MATHIEU</last_name>
    <phone>+ 33 4 76 76 55 97</phone>
    <email>nmathieu@chu-grenoble.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Laure Bordy</last_name>
    <phone>+ 33 4 76 76 61 50</phone>
    <email>lbordy@chu-grenoble.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Chu Grenoble Alpes</name>
      <address>
        <city>Grenoble Cedex 9</city>
        <zip>38043</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Nicolas MATTHIEU</last_name>
      <email>NMathieu@chu-grenoble.fr</email>
    </contact>
    <investigator>
      <last_name>Nicolas MATHIEU</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>September 2020</verification_date>
  <study_first_submitted>June 4, 2020</study_first_submitted>
  <study_first_submitted_qc>June 4, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 9, 2020</study_first_posted>
  <last_update_submitted>September 28, 2020</last_update_submitted>
  <last_update_submitted_qc>September 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT04422171
org study id: 38RC19.379
secondary id: 2020-A00494-35
nct id: NCT04422171
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Biosimilars represent great potential in cost saving and reinvestment opportunities in
      healthcare. Biosimilars of adalimumab appear to be clinically equivalent to the reference
      product in patients with rheumatoid arthritis and psoriasis. No data are currently available
      in IBD patients. Real-life data are needed.

      Minimizing the switch back is another clinical challenge in the current area of biosimilars.
      The primary objective of Rhoneswitch is to describe the magnitude of patient's switch back
      defined as a deterioration of symptoms without objective identification of disease activity,
      12 months after the switch from ada originator Humira®.

      The primary endpoint is to assess the percentage of patients who switch back to originator
      therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®,
      Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.
The subject will be include during usual hospital consultation after reviewing
      inclusion/exclusion criteria and obtain non opposition. Data will be collected during 3 usual
      hospital consultations: at month 3, month 6, and month 12. The end of study will be at month
      12 or at premature termination.

      Questionnaires will be done in addition during all usual hospital consultations.
observational model: Cohort
time perspective: Prospective
measure: Magnitude of patient's switch back defined as a deterioration of symptoms without objective identification of disease activity, 12 months after the switch from ada originator Humira®.
time frame: 12 months
description: Percentage of patients who switch back to originator therapy Humira® 12 months after switching from ada Humira® to ada Bs: Amgevita® ,Hulio®, Hyrimoz® or Imraldi® in IBD patients without any objective markers of inflammation.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 75 Years
healthy volunteers: No
last name: Nicolas Mathieu
role: Principal Investigator
affiliation: CHU Grenoble Alpes
last name: NICOLAS MATHIEU
phone: + 33 4 76 76 55 97
email: nmathieu@chu-grenoble.fr
last name: Laure Bordy
phone: + 33 4 76 76 61 50
email: lbordy@chu-grenoble.fr
facility: 
status: Recruiting
contact: 
investigator: 
country: France
responsible party type: Sponsor