<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/NCT03778840</url>
  </required_header>
  <id_info>
    <org_study_id>2018_06</org_study_id>
    <secondary_id>2018-A00188-47</secondary_id>
    <nct_id>NCT03778840</nct_id>
  </id_info>
  <brief_title>Study of Infections in Patients With Autoimmune Diseases Treated With Rituximab</brief_title>
  <acronym>EXPRIME</acronym>
  <official_title>Prospective Study of Incidence and Risk Factors of Infections and of Replacement Therapy With Intravenous Immunoglobulins for Secondary Immunodeficiency in Patients With Autoimmune Diseases Treated With Rituximab</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Lille</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Grifols Biologicals, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University Hospital, Lille</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>
      Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases&#xD;
      include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune&#xD;
      diseases.&#xD;
&#xD;
      The major drawback of this drug is the risk of infection, which are favored by the direct&#xD;
      effect of rituximab on the immune system. The risk of infection is one of the major reason&#xD;
      not to prescribe or withdraw rituximab in several patients. However, many questions remain&#xD;
      unanswered regarding the proportion and risk factors of infection or immunodeficiency induced&#xD;
      by rituximab. Better understanding of these issues will help prescribing rituximab and&#xD;
      properly monitor patients during their treatment. Moreover, as treatment with substitutive&#xD;
      immunoglobulins might be a solution to decrease the risk of infections in those patients, it&#xD;
      is very important to better characterize the risk and risk factors of rituximab-associated&#xD;
      infection. The present study aims to answer these questions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 29, 2019</start_date>
  <completion_date type="Actual">May 31, 2022</completion_date>
  <primary_completion_date type="Actual">May 31, 2022</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>Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab</measure>
    <time_frame>Within 12 months after inclusion</time_frame>
    <description>A serious infection event [SIE] defined as any infection which led to hospitalization and/or death and/or required treatment with intravenous antibiotic/antiviral drugs</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Hypogammaglobulinemia</measure>
    <time_frame>Within 12 months after inclusion</time_frame>
    <description>defined by immunoglobulin (Ig) G &lt;6g / L.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Replacement therapy with immunoglobulins</measure>
    <time_frame>Within 12 months after inclusion</time_frame>
    <description>Start of an immunoglobulins therapy to replace gammaglobulins</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hypersensitivity skin reaction secondary to RTX injection.</measure>
    <time_frame>Within 12 months after inclusion</time_frame>
    <description>Attack rate of cutaneous hypersensitivity reactions after RTX injection in patients with dysimmune disease.</description>
  </secondary_outcome>
  <enrollment type="Actual">73</enrollment>
  <condition>Autoimmune Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        The patients included in the study will be the patients beginning a cure of RTX prescribed&#xD;
        within the framework of the treatment of their inflammatory disease or dysimmunitaire&#xD;
        chronic.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient initiating treatment with RTX, delivered by the central pharmacy of Lille&#xD;
             University Hospital&#xD;
&#xD;
          -  Inpatient or outpatient at Lille University Hospital (in one of the following&#xD;
             departments: internal medicine, rheumatology, neurology, dermatology, pneumology) and&#xD;
             monitored every three months as part of routine care (as part of the surveillance of&#xD;
             induction of RTX treatment)&#xD;
&#xD;
          -  Patient with one of the following autoimmune diseases, defined by international&#xD;
             criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with rituximab for a malignancy or a transplant reject&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  People in emergency&#xD;
&#xD;
          -  Administrative reasons: inability to receive informed information, inability to&#xD;
             participate in the entire study, lack of coverage by the social security system,&#xD;
             refusal to sign consent&#xD;
&#xD;
          -  Persons deprived of their liberty&#xD;
&#xD;
          -  People unable to consent&#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>Vincent SOBANSKI, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University Hospital, Lille</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Hôpital Claude Huriez, CHU</name>
      <address>
        <city>Lille</city>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>January 2023</verification_date>
  <study_first_submitted>September 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 17, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>February 3, 2023</last_update_submitted>
  <last_update_submitted_qc>February 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 6, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Infections</keyword>
  <keyword>immunoglobulins</keyword>
  <keyword>secondary immunodeficiency</keyword>
  <keyword>rituximab</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Autoimmune 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/NCT03778840
org study id: 2018_06
secondary id: 2018-A00188-47
nct id: NCT03778840
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Rituximab is a very effective drug used to treat many inflammatory diseases. These diseases
      include, for example, rheumatoid arthritis, multiple sclerosis and systemic autoimmune
      diseases.

      The major drawback of this drug is the risk of infection, which are favored by the direct
      effect of rituximab on the immune system. The risk of infection is one of the major reason
      not to prescribe or withdraw rituximab in several patients. However, many questions remain
      unanswered regarding the proportion and risk factors of infection or immunodeficiency induced
      by rituximab. Better understanding of these issues will help prescribing rituximab and
      properly monitor patients during their treatment. Moreover, as treatment with substitutive
      immunoglobulins might be a solution to decrease the risk of infections in those patients, it
      is very important to better characterize the risk and risk factors of rituximab-associated
      infection. The present study aims to answer these questions.
observational model: Cohort
time perspective: Prospective
measure: Occurrence of a serious infection event [SIE] in patient with an autoimmune disease treated with rituximab
time frame: Within 12 months after inclusion
description: A serious infection event [SIE] defined as any infection which led to hospitalization and/or death and/or required treatment with intravenous antibiotic/antiviral drugs
measure: Hypogammaglobulinemia
time frame: Within 12 months after inclusion
description: defined by immunoglobulin (Ig) G <6g / L.
measure: Replacement therapy with immunoglobulins
time frame: Within 12 months after inclusion
description: Start of an immunoglobulins therapy to replace gammaglobulins
measure: Hypersensitivity skin reaction secondary to RTX injection.
time frame: Within 12 months after inclusion
description: Attack rate of cutaneous hypersensitivity reactions after RTX injection in patients with dysimmune disease.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vincent SOBANSKI, MD, PhD
role: Principal Investigator
affiliation: University Hospital, Lille
facility: 
country: France
responsible party type: Sponsor
mesh term: Infections
mesh term: Autoimmune Diseases