<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/NCT04407923</url>
  </required_header>
  <id_info>
    <org_study_id>RHUMAJICOVID (29BRC20.0148)</org_study_id>
    <nct_id>NCT04407923</nct_id>
  </id_info>
  <brief_title>Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context : Impact on Therapeutical Managment</brief_title>
  <acronym>RHUMAJICOVID</acronym>
  <official_title>Drug Management of Juvenile Idiopathic Arthritis in Covid-19 Context</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University Hospital, Brest</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University Hospital, Brest</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>
      The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among&#xD;
      patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune&#xD;
      diseases, there may be legitimates interrogations about the appropriateness of continuing&#xD;
      treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is&#xD;
      concerns by these fears (the patient and their parents). Patients are treated by several&#xD;
      classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs,&#xD;
      corticosteroids and disease modifying anti-rheumatic drugs. The present study will&#xD;
      characterize this issue by defining the proportion of patients whose usual treatment of&#xD;
      Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis,&#xD;
      and also to return to school.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 25, 2020</start_date>
  <completion_date type="Anticipated">November 25, 2020</completion_date>
  <primary_completion_date type="Anticipated">November 25, 2020</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>Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis</measure>
    <time_frame>1 Day</time_frame>
    <description>Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD</description>
  </primary_outcome>
  <enrollment type="Anticipated">150</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <condition>COVID 19</condition>
  <condition>Treatment</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Juvenile Idiopathic Arthritis patients with ongoing DMARD therapy.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Juvenile Idiopathic Arthritis satisfying Edmonton criteria&#xD;
&#xD;
          -  Ongoing DMARD therapy or AINS for 3 months&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Inhability to consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>17 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Valerie DEVAUCHELLE</last_name>
    <phone>02 98 34 72 64</phone>
    <email>valerie.devauchelle-pensec@chu-brest.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Valerie DEVAUCHELLE</last_name>
    <email>valerie.devauchelle-pensec@chu-brest.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>CH de Belfort</name>
      <address>
        <city>Belfort</city>
        <zip>90015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Anne Lohse</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Bordeaux</name>
      <address>
        <city>Bordeaux</city>
        <zip>33000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Pascal Pillet</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHRU de Brest</name>
      <address>
        <city>Brest</city>
        <zip>29609</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Valerie Devauchelle-Pensec</last_name>
      <email>valerie.devauchelle-pensec@chu-brest.fr</email>
    </contact>
  </location>
  <location>
    <facility>
      <name>AP-HP Hôpital Kremlin-Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <zip>94275</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Linda Rossi</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Elisabeth Gervais</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35000</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Véronique Despert</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Strasbourg</name>
      <address>
        <city>Strasbourg</city>
        <zip>67200</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Christelle Sordet</last_name>
    </contact>
  </location>
  <location>
    <facility>
      <name>CHU de Nancy</name>
      <address>
        <city>Vandœuvre les Nancy</city>
        <zip>54711</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <contact>
      <last_name>Irène Lemelle</last_name>
    </contact>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 28, 2020</study_first_submitted>
  <study_first_submitted_qc>May 28, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 29, 2020</study_first_posted>
  <last_update_submitted>May 28, 2020</last_update_submitted>
  <last_update_submitted_qc>May 28, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 29, 2020</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>COVID-19</mesh_term>
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available beginning six months and ending five years following the end study</ipd_time_frame>
    <ipd_access_criteria>Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.</ipd_access_criteria>
  </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/NCT04407923
org study id: RHUMAJICOVID (29BRC20.0148)
nct id: NCT04407923
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The current situation of Sars-Cov-2 pandemic generates fears in the general population. Among
      patients receiving long-term immunomodulatory drugs, especially in the context of auto-immune
      diseases, there may be legitimates interrogations about the appropriateness of continuing
      treatment, without modification, in the current context. Juvenile Idiopathic Arthritis is
      concerns by these fears (the patient and their parents). Patients are treated by several
      classes of immunomodulatory drugs, including non-steroidal anti-inflammatory drugs,
      corticosteroids and disease modifying anti-rheumatic drugs. The present study will
      characterize this issue by defining the proportion of patients whose usual treatment of
      Juvenile Idiopathic Arthritis has been modified in relation to the actual sanitary crisis,
      and also to return to school.
observational model: Cohort
time perspective: Prospective
measure: Reduction or discontinuation of the DMARD therapy in relation to the Covid-19 sanitary crisis
time frame: 1 Day
description: Reduction or discontinuation of treatment with sDMARD, bDMARD or tsDMARD
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 17 Years
healthy volunteers: No
last name: Valerie DEVAUCHELLE
phone: 02 98 34 72 64
email: valerie.devauchelle-pensec@chu-brest.fr
last name: Valerie DEVAUCHELLE
email: valerie.devauchelle-pensec@chu-brest.fr
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
facility: 
status: Not yet recruiting
contact: 
country: France
responsible party type: Sponsor
mesh term: COVID-19
mesh term: Arthritis
mesh term: Arthritis, Juvenile
sharing ipd: Yes
ipd info type: Study Protocol
ipd time frame: Data will be available beginning six months and ending five years following the end study
ipd access criteria: Data access requests will be reviewed by the internal committee of Brest UH. Requestors will be required to sign and complete a data access agreement.