<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/NCT03790293</url>
  </required_header>
  <id_info>
    <org_study_id>2018/070/HP</org_study_id>
    <nct_id>NCT03790293</nct_id>
  </id_info>
  <brief_title>Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the &quot;RITUXIMAB 3&quot; Trial</brief_title>
  <acronym>LTFURITUX3</acronym>
  <official_title>Clinical and Immunological Long-term Follow-up of Patients With Pemphigus Included in the &quot;RITUXIMAB 3&quot; Trial With Medico-economic Evaluation of the Treatment.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Rouen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Rouen</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Pemphigus is an autoimmune disease specific to the skin and mucous membranes characterized by&#xD;
      the production of IgG4 isotype autoantibodies (AC) directed mainly against two proteins&#xD;
      involved in interkeratinocyte adhesion: desmoglein 1 (Dsg1 ) and desmoglein 3 (Dsg3) (1-3).&#xD;
      The binding of auto-AC on these proteins disrupts their adhesion function, resulting in&#xD;
      inter-keratinocyte dysjunction called &quot;acantholysis&quot; responsible for the formation of&#xD;
      intraepidermal bubbles.&#xD;
&#xD;
      Treatment of pemphigus is typically based on systemic corticosteroids. High doses are usually&#xD;
      necessary because of the frequent cortico-resistance of the disease. In recent years, several&#xD;
      studies have focused on the treatment of pemphigus with anti-CD20: rituximab. The &quot;Ritux 3&quot;&#xD;
      study (NCT00784589), a randomized, multicentre, randomized, non-blind clinical trial&#xD;
      involving 90 patients, found that the use of rituximab as first-line therapy in combination&#xD;
      with short corticosteroid therapy was extremely effective and that cortisone sparing was thus&#xD;
      obtained limited the occurrence of side effects of treatment. On the other hand, this study&#xD;
      showed that the 2 rituximab maintenance infusions of 500 mg to M12 and M18 allowed the&#xD;
      maintenance of a high rate of complete remission up to the 3rd year of follow-up.&#xD;
&#xD;
      Questions remain to explain the long-term action of rituximab, in particular that of the&#xD;
      evolution of these auto-reactive B cells (specific DSG) away from lymphocyte reconstitution&#xD;
      B, as well as the evolution of auto-AC. anti-DSG and total IgG CAs, so as to ensure that the&#xD;
      disappearance of the auto-reactive compartment is not accompanied by a long-term overall&#xD;
      immunosuppression (and therefore a possible risk of infection).&#xD;
&#xD;
      The immunological changes induced in the long term as well as the precise mechanism of action&#xD;
      of these treatments and particularly rituximab which allows a complete remission 5 years&#xD;
      after treatment in many patients remain little known.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">December 2019</start_date>
  <completion_date type="Anticipated">December 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2019</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>Patients included and treated in the RITUXIMAB 3 study (NCT00784589):&#xD;
Rituximab in combination with reduced corticosteroids&#xD;
Standard corticosteroid</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Evaluate the occurrence of long-term serious AEs and AEs in patients initially randomized in the rituximab arm and in those who have secondarily received the product during the course of their pemphigus</measure>
    <time_frame>1 day: 5 to 7 years after the inclusion into RITUXIMAB 3 study</time_frame>
    <description>Collect of SAE and AE</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Evaluate the long-term relapse rate in patients initially randomized in the rituximab arm and in those who have secondarily received the product during the course of their pemphigus</measure>
    <time_frame>1 day: 5 to 7 years after the inclusion into RITUXIMAB 3 study</time_frame>
    <description>Collect of relapses</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Autoimmune Diseases</condition>
  <arm_group>
    <arm_group_label>Rituximab</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Rituximab in combination with reduced corticosteroids is administrated</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Standard corticosteroid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard corticosteroid is administrated</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Rituximab</intervention_name>
    <description>Patient was enrolled into the RITUXIMAB 3 study in the arm Rituximab in association with low corticosteroids'therapy</description>
    <arm_group_label>Rituximab</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>corticosteroids'therapy</intervention_name>
    <description>Patient was enrolled into the RITUXIMAB 3 study in the arm Patient was enrolled into the RITUXIMAB 3 study in the arm standard corticosteroid</description>
    <arm_group_label>Rituximab</arm_group_label>
    <arm_group_label>Standard corticosteroid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient included in the RITUXIMAB 3 study&#xD;
&#xD;
          -  Major patient who has read and understood the newsletter and signed the consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Person deprived of liberty by an administrative or judicial decision&#xD;
&#xD;
          -  Person placed under the safeguard of justice&#xD;
&#xD;
          -  Person under tutorship or curators&#xD;
&#xD;
          -  Pregnant or lactating woman&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>80 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Pascal JOLY</last_name>
    <phone>0033232886841</phone>
    <email>pascal.joly@chu-rouen.fr</email>
  </overall_contact>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>October 8, 2018</study_first_submitted>
  <study_first_submitted_qc>December 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 31, 2018</study_first_posted>
  <last_update_submitted>December 27, 2018</last_update_submitted>
  <last_update_submitted_qc>December 27, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 31, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pemphigus</mesh_term>
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Rituximab</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03790293
org study id: 2018/070/HP
nct id: NCT03790293
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
Pemphigus is an autoimmune disease specific to the skin and mucous membranes characterized by
      the production of IgG4 isotype autoantibodies (AC) directed mainly against two proteins
      involved in interkeratinocyte adhesion: desmoglein 1 (Dsg1 ) and desmoglein 3 (Dsg3) (1-3).
      The binding of auto-AC on these proteins disrupts their adhesion function, resulting in
      inter-keratinocyte dysjunction called "acantholysis" responsible for the formation of
      intraepidermal bubbles.

      Treatment of pemphigus is typically based on systemic corticosteroids. High doses are usually
      necessary because of the frequent cortico-resistance of the disease. In recent years, several
      studies have focused on the treatment of pemphigus with anti-CD20: rituximab. The "Ritux 3"
      study (NCT00784589), a randomized, multicentre, randomized, non-blind clinical trial
      involving 90 patients, found that the use of rituximab as first-line therapy in combination
      with short corticosteroid therapy was extremely effective and that cortisone sparing was thus
      obtained limited the occurrence of side effects of treatment. On the other hand, this study
      showed that the 2 rituximab maintenance infusions of 500 mg to M12 and M18 allowed the
      maintenance of a high rate of complete remission up to the 3rd year of follow-up.

      Questions remain to explain the long-term action of rituximab, in particular that of the
      evolution of these auto-reactive B cells (specific DSG) away from lymphocyte reconstitution
      B, as well as the evolution of auto-AC. anti-DSG and total IgG CAs, so as to ensure that the
      disappearance of the auto-reactive compartment is not accompanied by a long-term overall
      immunosuppression (and therefore a possible risk of infection).

      The immunological changes induced in the long term as well as the precise mechanism of action
      of these treatments and particularly rituximab which allows a complete remission 5 years
      after treatment in many patients remain little known.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Patients included and treated in the RITUXIMAB 3 study (NCT00784589):
Rituximab in combination with reduced corticosteroids
Standard corticosteroid
primary purpose: Treatment
masking: None (Open Label)
measure: Evaluate the occurrence of long-term serious AEs and AEs in patients initially randomized in the rituximab arm and in those who have secondarily received the product during the course of their pemphigus
time frame: 1 day: 5 to 7 years after the inclusion into RITUXIMAB 3 study
description: Collect of SAE and AE
measure: Evaluate the long-term relapse rate in patients initially randomized in the rituximab arm and in those who have secondarily received the product during the course of their pemphigus
time frame: 1 day: 5 to 7 years after the inclusion into RITUXIMAB 3 study
description: Collect of relapses
arm group label: Rituximab
arm group type: Experimental
description: Rituximab in combination with reduced corticosteroids is administrated
arm group label: Standard corticosteroid
arm group type: Active Comparator
description: Standard corticosteroid is administrated
intervention type: Drug
intervention name: Rituximab
description: Patient was enrolled into the RITUXIMAB 3 study in the arm Rituximab in association with low corticosteroids'therapy
arm group label: Rituximab
intervention type: Drug
intervention name: corticosteroids'therapy
description: Patient was enrolled into the RITUXIMAB 3 study in the arm Patient was enrolled into the RITUXIMAB 3 study in the arm standard corticosteroid
arm group label: Rituximab
arm group label: Standard corticosteroid
criteria: 
gender: All
minimum age: 18 Years
maximum age: 80 Years
healthy volunteers: No
last name: Pascal JOLY
phone: 0033232886841
email: pascal.joly@chu-rouen.fr
responsible party type: Sponsor
mesh term: Pemphigus
mesh term: Autoimmune Diseases
mesh term: Rituximab
sharing ipd: Undecided