<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/NCT02998398</url>
  </required_header>
  <id_info>
    <org_study_id>NI-16-004</org_study_id>
    <secondary_id>2016-A02016-A00700-51</secondary_id>
    <nct_id>NCT02998398</nct_id>
  </id_info>
  <brief_title>Evaluation of the Switch From the Original Infliximab to Its Biosimilar in Daily Practice at Cochin Hospital</brief_title>
  <acronym>SIC</acronym>
  <official_title>Evaluation of the Switch From the Original Infliximab ( REMICADE®) to Its Biosimilar (INFLECTRA®) in Daily Practice at Cochin Hospital</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Assistance Publique - Hôpitaux de Paris</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Assistance Publique - Hôpitaux de Paris</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the effectiveness of the switch from the original&#xD;
      infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital&#xD;
      receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      All patients managed in one of the departments of cochin Hospital who are receiving the&#xD;
      original infliximab ( REMICADE®) from at least 4 months will be invited to continue to&#xD;
      receive infliximab but using its biosimilar (INFLECTRA®)) at the same regimen (identical dose&#xD;
      per infusion and interval between two infusions) than the previous one while receiving&#xD;
      REMICADE®. The tolerability of the infusion will be recorded as well as the percentage of&#xD;
      patients continuing INFLECTRA® after at least six months of its initiation.&#xD;
&#xD;
      Moreover, the infliximab serum level will be evaluated after the last infusion of REMICADE®&#xD;
      and after the third infusion of INFLECTRA®. At the same time, anti-drug antibodies will be&#xD;
      tested.&#xD;
&#xD;
      Finally for each of the underlying disease (e.g. rheumatoid arthritis, spondyloarthritis,&#xD;
      Crohn's disease, uveitis,..), the maintenance of the efficacy of Infliximab will be evaluated&#xD;
      according to the usual outcome measures of the activity of the disease&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 2015</start_date>
  <completion_date type="Actual">June 29, 2016</completion_date>
  <primary_completion_date type="Actual">June 2016</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>Percentage of patients continuing INFLECTRA®</measure>
    <time_frame>after the third infusion of INFLECTRA®, up to 24 weeks</time_frame>
    <description>Evaluation of the percentage of patients continuing INFLECTRA® after its third infusion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Infliximab serum level</measure>
    <time_frame>after the third infusion of INFLECTRA®, up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with a flare of their disease</measure>
    <time_frame>after the third infusion of INFLECTRA®, up to 24 weeks</time_frame>
    <description>The flare will be assessed by usual physiological parameter of the disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with anti-drug antibodies assessed after the third infusion of INFLECTRA®</measure>
    <time_frame>after the third infusion of INFLECTRA®, up to 24 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of patients with anti drug antibodies assessed after the last infusion of REMICADE®</measure>
    <time_frame>after the last infusion of REMICADE®, up to 24 weeks</time_frame>
  </secondary_outcome>
  <enrollment type="Actual">262</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Spondyloarthritis</condition>
  <condition>Crohn's Disease</condition>
  <condition>Uveitis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Switch from REMICADE® to INFLECTRA®</intervention_name>
    <description>Treatment with an infliximab biosimilar (i.e. INFLECTRA® ) for all patients which have been treated by REMICADE® for at least 4 months</description>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      serum&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        All patients managed in one of the departments of cochin Hospital who are receiving the&#xD;
        original infliximab ( REMICADE®) from at least 4 months&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Male or female over 18 year old&#xD;
&#xD;
          -  Patient treated with REMICADE® in Cochin hospital&#xD;
&#xD;
          -  More than 3 perfusions of REMICADE® before the switch to INFLECTRA®&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Maxime DOUGADOS, MD, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Assistance Publique - Hôpitaux de Paris</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Cochin</name>
      <address>
        <city>Paris</city>
        <zip>75014</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>May 17, 2016</study_first_submitted>
  <study_first_submitted_qc>December 15, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 20, 2016</study_first_posted>
  <last_update_submitted>April 30, 2021</last_update_submitted>
  <last_update_submitted_qc>April 30, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">May 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Biosimilar</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylitis</mesh_term>
    <mesh_term>Spondylarthritis</mesh_term>
    <mesh_term>Crohn Disease</mesh_term>
    <mesh_term>Uveitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infliximab</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/NCT02998398
org study id: NI-16-004
secondary id: 2016-A02016-A00700-51
nct id: NCT02998398
lead sponsor: 
has dmc: No
The purpose of this study is to evaluate the effectiveness of the switch from the original
      infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital
      receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition
All patients managed in one of the departments of cochin Hospital who are receiving the
      original infliximab ( REMICADE®) from at least 4 months will be invited to continue to
      receive infliximab but using its biosimilar (INFLECTRA®)) at the same regimen (identical dose
      per infusion and interval between two infusions) than the previous one while receiving
      REMICADE®. The tolerability of the infusion will be recorded as well as the percentage of
      patients continuing INFLECTRA® after at least six months of its initiation.

      Moreover, the infliximab serum level will be evaluated after the last infusion of REMICADE®
      and after the third infusion of INFLECTRA®. At the same time, anti-drug antibodies will be
      tested.

      Finally for each of the underlying disease (e.g. rheumatoid arthritis, spondyloarthritis,
      Crohn's disease, uveitis,..), the maintenance of the efficacy of Infliximab will be evaluated
      according to the usual outcome measures of the activity of the disease
observational model: Cohort
time perspective: Retrospective
measure: Percentage of patients continuing INFLECTRA®
time frame: after the third infusion of INFLECTRA®, up to 24 weeks
description: Evaluation of the percentage of patients continuing INFLECTRA® after its third infusion
measure: Infliximab serum level
time frame: after the third infusion of INFLECTRA®, up to 24 weeks
measure: Percentage of patients with a flare of their disease
time frame: after the third infusion of INFLECTRA®, up to 24 weeks
description: The flare will be assessed by usual physiological parameter of the disease
measure: Percentage of patients with anti-drug antibodies assessed after the third infusion of INFLECTRA®
time frame: after the third infusion of INFLECTRA®, up to 24 weeks
measure: Percentage of patients with anti drug antibodies assessed after the last infusion of REMICADE®
time frame: after the last infusion of REMICADE®, up to 24 weeks
intervention type: Other
intervention name: Switch from REMICADE® to INFLECTRA®
description: Treatment with an infliximab biosimilar (i.e. INFLECTRA® ) for all patients which have been treated by REMICADE® for at least 4 months
serum
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Maxime DOUGADOS, MD, PhD
role: Study Chair
affiliation: Assistance Publique - Hôpitaux de Paris
facility: 
country: France
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Spondylarthritis
mesh term: Crohn Disease
mesh term: Uveitis
mesh term: Infliximab
sharing ipd: No