<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/NCT01727232</url>
  </required_header>
  <id_info>
    <org_study_id>Mondor-Rituxcompare</org_study_id>
    <nct_id>NCT01727232</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia</brief_title>
  <official_title>Efficacy and Safety of Rituximab Given at Fixed Dose (1000 mg on Days 1 and 15) Compared to the Standard Regimen in Adult's Immune Thrombocytopenia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Henri Mondor University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Henri Mondor University Hospital</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this large French multicentric retrospective study was to compare the efficacy and&#xD;
      safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's&#xD;
      immune thrombocytopenia .&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Every adult (age ≥ 18 years) seen in one of the 3 participating centre (dijon, Marseille,&#xD;
      Mondor) over a 7-year period (2005-2012) with a definite diagnosis of primary ITP according&#xD;
      to the American Society Hematology guidelines who received RTX regardless the regimen could&#xD;
      be included.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>January 2007</start_date>
  <completion_date type="Actual">October 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</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>The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion.</measure>
    <time_frame>one year</time_frame>
    <description>A complete response (CR) was defined as a platelet count &gt;100 x 109/l and a response (R): by a platelet count &gt;30 x 109/l with a least a doubling of the baseline value without any rescue intervention within 8 weeks before assessment, and no response (NR) was defined as a platelet count lower than 30 x 109/</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response.</measure>
    <time_frame>3 months, one year, last follow-up</time_frame>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">107</enrollment>
  <condition>Primary Immune Thrombocytopenia</condition>
  <arm_group>
    <arm_group_label>Standard regimen</arm_group_label>
    <description>Patients received the standard regimen (i.e 4 weekly infusions of 375 mg/m2)of rituximab</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Rheumatoid arthritis regimen</arm_group_label>
    <description>Patients received the RA regimen (i.e two infusions of 1000 mg, 2 weeks apart) of rituximab</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Primary ITP patients treated with standard or RA regimen were retrospectively included in&#xD;
        the observationnal study.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Primary ITP&#xD;
&#xD;
          -  Age &gt; 18 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Secondary ITP&#xD;
&#xD;
          -  Age &lt; 18 years&#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>November 2012</verification_date>
  <study_first_submitted>November 12, 2012</study_first_submitted>
  <study_first_submitted_qc>November 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 15, 2012</study_first_posted>
  <last_update_submitted>November 12, 2012</last_update_submitted>
  <last_update_submitted_qc>November 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 15, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Henri Mondor University Hospital</investigator_affiliation>
    <investigator_full_name>Dr Mahévas Matthieu, MD</investigator_full_name>
    <investigator_title>MD</investigator_title>
  </responsible_party>
  <keyword>ITP</keyword>
  <keyword>Rituximab</keyword>
  <keyword>Efficacy</keyword>
  <keyword>Anti-CD20</keyword>
  <keyword>Regimen</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Thrombocytopenia</mesh_term>
    <mesh_term>Purpura, Thrombocytopenic, Idiopathic</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/NCT01727232
org study id: Mondor-Rituxcompare
nct id: NCT01727232
lead sponsor: 
has dmc: No
The aim of this large French multicentric retrospective study was to compare the efficacy and
      safety of two (the standard and the Rheumatoid arthritis) rituximab regimens in adult's
      immune thrombocytopenia .
Every adult (age ≥ 18 years) seen in one of the 3 participating centre (dijon, Marseille,
      Mondor) over a 7-year period (2005-2012) with a definite diagnosis of primary ITP according
      to the American Society Hematology guidelines who received RTX regardless the regimen could
      be included.
observational model: Cohort
time perspective: Retrospective
measure: The primary end point of the study was to assess the response rate to treatment 1 year after the first rituximab infusion.
time frame: one year
description: A complete response (CR) was defined as a platelet count >100 x 109/l and a response (R): by a platelet count >30 x 109/l with a least a doubling of the baseline value without any rescue intervention within 8 weeks before assessment, and no response (NR) was defined as a platelet count lower than 30 x 109/
measure: The response rate 3months, and at the last follow-up after the first rituximab infusion. Variable associated with RTX response.
time frame: 3 months, one year, last follow-up
arm group label: Standard regimen
description: Patients received the standard regimen (i.e 4 weekly infusions of 375 mg/m2)of rituximab
arm group label: Rheumatoid arthritis regimen
description: Patients received the RA regimen (i.e two infusions of 1000 mg, 2 weeks apart) of rituximab
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
responsible party type: Principal Investigator
investigator affiliation: Henri Mondor University Hospital
investigator full name: Dr Mahévas Matthieu, MD
investigator title: MD
mesh term: Thrombocytopenia
mesh term: Purpura, Thrombocytopenic, Idiopathic