<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/NCT03773965</url>
  </required_header>
  <id_info>
    <org_study_id>16278</org_study_id>
    <secondary_id>I4V-MC-JAHX</secondary_id>
    <secondary_id>2017-004471-31</secondary_id>
    <nct_id>NCT03773965</nct_id>
  </id_info>
  <brief_title>A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis</brief_title>
  <acronym>JUVE-X</acronym>
  <official_title>A Phase 3 Multicenter Study to Evaluate the Long-Term Safety and Efficacy of Baricitinib in Patients From 1 Year to &lt;18 Years of Age With Juvenile Idiopathic Arthritis (JIA)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eli Lilly and Company</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eli Lilly and Company</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The reason for this study is to see if the study drug baricitinib is safe and effective in&#xD;
      the treatment of JIA in participants ages 1 to 17. This study is for participants that have&#xD;
      been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">April 5, 2019</start_date>
  <completion_date type="Anticipated">December 18, 2030</completion_date>
  <primary_completion_date type="Anticipated">December 18, 2030</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants with One or More Serious Adverse Event(s) (SAEs)</measure>
    <time_frame>Baseline through Week 264</time_frame>
    <description>Number of participants with one or more SAEs</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants with Permanent Investigational Product Discontinuations</measure>
    <time_frame>Baseline through Week 264</time_frame>
    <description>Number of participants with permanent investigational product discontinuations</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)</measure>
    <time_frame>Week 264</time_frame>
    <description>Proportion of participants achieving PedACR30</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants who have Disease Flare</measure>
    <time_frame>Baseline through Week 264</time_frame>
    <description>Proportion of participants who have disease flare</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with Inactive Disease</measure>
    <time_frame>Week 264</time_frame>
    <description>Proportion of participants with inactive disease</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants with Minimal Disease Activity</measure>
    <time_frame>Week 264</time_frame>
    <description>Proportion of participants with minimal disease activity</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of Participants in Remission</measure>
    <time_frame>Week 264</time_frame>
    <description>Proportion of participants in remission</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)</measure>
    <time_frame>Baseline, Week 264</time_frame>
    <description>Change from baseline of originating study in JADAS27</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item</measure>
    <time_frame>Baseline, Week 264</time_frame>
    <description>Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Psoriasis Area and Severity Index (PASI)</measure>
    <time_frame>Baseline, Week 264</time_frame>
    <description>Change from baseline in PASI</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index</measure>
    <time_frame>Baseline, Week 264</time_frame>
    <description>Change from baseline in SPARCC enthesitis index</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)</measure>
    <time_frame>Baseline, Week 264</time_frame>
    <description>Change from baseline in JSpADA</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Immunoglobulin Levels</measure>
    <time_frame>Baseline, Week 264</time_frame>
    <description>Change from baseline in immunoglobulin levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Immunophenotyping (T Cells)</measure>
    <time_frame>Baseline, Week 264</time_frame>
    <description>Change from baseline in immunophenotyping (T Cells)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change of Immunoglobulin G (IgG) Titers</measure>
    <time_frame>Pre-Vaccination to 12 Weeks Post-Vaccination</time_frame>
    <description>Change of IgG titers</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Anticipated">190</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>Baricitinib</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Baricitinib given orally.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Baricitinib</intervention_name>
    <description>Administered orally.</description>
    <arm_group_label>Baricitinib</arm_group_label>
    <other_name>LY3009104</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participants must have completed a previous study of baricitinib for the treatment of&#xD;
             JIA.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants must not have had a permanent discontinuation of baricitinib in the prior&#xD;
             study.&#xD;
&#xD;
          -  Participants must have not developed an allergy to baricitinib.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Year</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)</last_name>
    <role>Study Director</role>
    <affiliation>Eli Lilly and Company</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or</last_name>
    <phone>1-317-615-4559</phone>
    <email>ClinicalTrials.gov@lilly.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Instituto CAICI SRL</name>
      <address>
        <city>Rosario</city>
        <state>Santa Fe</state>
        <zip>S2000</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Diego Oscar Viola</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centro Medico Privado de Reumatologia</name>
      <address>
        <city>SAN M. DE Tucuman</city>
        <state>Tucumán</state>
        <zip>T4000AXL</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alberto Jorge Spindler</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital General de Niños Dr. Pedro de Elizalde</name>
      <address>
        <city>Buenos Aires</city>
        <zip>1270</zip>
        <country>Argentina</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ruben José Cuttica</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital at Westmead</name>
      <address>
        <city>Westmead</city>
        <state>New South Wales</state>
        <zip>2145</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Royal Children's Hospital</name>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3052</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jonathan Akikusa</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Perth Children's Hospital</name>
      <address>
        <city>Perth</city>
        <state>Western Australia</state>
        <zip>6009</zip>
        <country>Australia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>61264564348</phone>
    </contact>
    <investigator>
      <last_name>Kevin Murray</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Landeskrankenhaus Bregenz</name>
      <address>
        <city>Bregenz</city>
        <state>Vorarlberg</state>
        <zip>6900</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Medizinische Universität Wien</name>
      <address>
        <city>Vienna</city>
        <state>Wien</state>
        <zip>1090</zip>
        <country>Austria</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Wolfgang Emminger</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Cliniques universitaires Saint-Luc</name>
      <address>
        <city>Brussels</city>
        <state>Bruxelles-Capitale, Région De</state>
        <zip>1200</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Cecile Boulanger</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UZ Gent</name>
      <address>
        <city>Gent</city>
        <state>Oost-Vlaanderen</state>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Joke Dehoorne</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Lien De Somer</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>CMIP - Centro Mineiro de Pesquisa</name>
      <address>
        <city>Juiz de Fora</city>
        <state>Minas Gerais</state>
        <zip>36010-570</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>553233128920</phone>
    </contact>
    <investigator>
      <last_name>Vania Shinzel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Unidade de Pesquisa em Reumatologia</name>
      <address>
        <city>Porto Alegre</city>
        <state>Rio Grande Do Sul</state>
        <zip>90035-903</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Claiton Viegas Brenol</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Faculdade de Medicina da UNESP</name>
      <address>
        <city>Botucatu</city>
        <state>São Paulo</state>
        <zip>18618-686</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Claudia Saad Magalhaes</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital de Clínicas Da Universidade Estadual de Campinas</name>
      <address>
        <city>Campinas</city>
        <state>São Paulo</state>
        <zip>13083-888</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Simone Appenzeller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Instituto da Crianca do Hospital das Clinicas da FMUSP</name>
      <address>
        <city>Sao Paulo</city>
        <state>São Paulo</state>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Clovis Silva</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IPPMG - Biblioteca Asdrubal Costa</name>
      <address>
        <city>Rio de Janeiro</city>
        <zip>21941-612</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>FLAVIO ROBERTO SZTAJNBOK</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IPITEC</name>
      <address>
        <city>São Paulo</city>
        <zip>01223-001</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Maria Carolina dos Santos</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universidade Federal de Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <zip>04024-002</zip>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Maria Terreri</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital Capital Institute of Pediatrics</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100020</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zhixuan Zhou</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Beijing Children's hospital, Capital Medical University</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100045</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Beijing Peking Union Medical College Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100730</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Mengtao NA Li</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Second Affiliated Hospital Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400010</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Lin Tang</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>The Children's Hospital of Chongqing Medical University</name>
      <address>
        <city>Chongqing</city>
        <state>Chongqing</state>
        <zip>400065</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Active, not recruiting</status>
  </location>
  <location>
    <facility>
      <name>Childrens Hospital of Nanjing Medical University</name>
      <address>
        <city>Nanjing</city>
        <state>Jiangsu</state>
        <zip>210008</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Haiguo Yu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Children's Hospital of Soochow University</name>
      <address>
        <city>Suzhou</city>
        <state>Jiangsu</state>
        <zip>215025</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Qihua Feng</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Detska nemocnice FN Brno</name>
      <address>
        <city>Brno</city>
        <state>Brno-město</state>
        <zip>613 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Marcel Schuller</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Motol</name>
      <address>
        <city>Praha</city>
        <state>Praha 5</state>
        <zip>150 06</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Rudolf Horvath</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fakultni nemocnice Olomouc</name>
      <address>
        <city>Olomouc</city>
        <zip>779 00</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Katerina Bouchalova</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Vseobecna fakultni nemocnice v Praze</name>
      <address>
        <city>Praha 2</city>
        <zip>12808</zip>
        <country>Czechia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Pavla Dolezalova</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rigshospitalet</name>
      <address>
        <city>Copenhagen</city>
        <state>Hovedstaden</state>
        <zip>DK-2100</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Charlotte Myrup</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Aarhus Universitetshospital, Skejby</name>
      <address>
        <city>Aarhus</city>
        <state>Midtjylland</state>
        <zip>8200</zip>
        <country>Denmark</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Mia Glerup</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Nîmes - Hôpital Universitaire Carémeau</name>
      <address>
        <city>Nîmes</city>
        <state>Gard</state>
        <zip>30029</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Tu-Anh TRAN</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpitaux Universitaires Paris Sud - Hôpital Bicêtre</name>
      <address>
        <city>Le Kremlin-Bicêtre</city>
        <state>Paris</state>
        <zip>94270</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>isabelle Kone-Paut</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospices Civils de Lyon - Hôpital Femme Mère Enfant</name>
      <address>
        <city>Bron</city>
        <state>Rhône-Alpes</state>
        <zip>69500</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alexandre BELOT</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centre Hospitalier Universitaire de Poitiers</name>
      <address>
        <city>Poitiers</city>
        <state>Vienne</state>
        <zip>86021</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Elisabeth Gervais</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hôpital Universitaire Necker Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Pierre Quartier Dit Maire</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Universitätsklinikum Heidelberg</name>
      <address>
        <city>Heidelberg</city>
        <state>Baden-Württemberg</state>
        <zip>69120</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Universitaetsklinikum Tuebingen</name>
      <address>
        <city>Tuebingen</city>
        <state>Baden-Württemberg</state>
        <zip>72076</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jasmin Kuemmerle-Deschner</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Asklepios Klinik Sankt Augustin</name>
      <address>
        <city>Sankt Augustin</city>
        <state>Nordrhein-Westfalen</state>
        <zip>53757</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Gerd Horneff</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Helios Klinikum Berlin-Buch</name>
      <address>
        <city>Berlin</city>
        <zip>13125</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ralf Trauzeddel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Charité Campus Virchow-Klinikum</name>
      <address>
        <city>Berlin</city>
        <zip>13353</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Kirsten Minden</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Praxis Kinder- und Jugendrheumatologie Dr. Ivan Foeldvari</name>
      <address>
        <city>Hamburg</city>
        <zip>22081</zip>
        <country>Germany</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ivan Foeldvari</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sir Ganga Ram Hospital</name>
      <address>
        <city>New Delhi</city>
        <state>Delhi</state>
        <zip>110060</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sujata Sawhney</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sri Ramachandra MedicaL College &amp; Research Institute</name>
      <address>
        <city>Chennai</city>
        <state>Tamil Nadu</state>
        <zip>600116</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Christian Medical College Vellore</name>
      <address>
        <city>Vellore</city>
        <state>Tamil Nadu</state>
        <zip>632004</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sathish Kumar</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Meir Medical Center</name>
      <address>
        <city>Kfar Saba</city>
        <state>HaMerkaz</state>
        <zip>4428164</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yosef Uziel</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Schneider Children's Medical Center</name>
      <address>
        <city>Petah Tikva</city>
        <state>HaMerkaz</state>
        <zip>49202</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Gil Amarilyo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sheba Medical Center</name>
      <address>
        <city>Ramat Gan</city>
        <state>HaMerkaz</state>
        <zip>5262100</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Irit Tirosh</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Rambam Health Care Campus</name>
      <address>
        <city>Haifa</city>
        <state>Ḥeifā</state>
        <zip>3109601</zip>
        <country>Israel</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yonatan Butbul</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University of Naples Federico II</name>
      <address>
        <city>Napoli</city>
        <state>Campania</state>
        <zip>80131</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Maria Alessio</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>IRCCS Istituto Giannina Gaslini</name>
      <address>
        <city>Genova</city>
        <state>Liguria</state>
        <zip>16147</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Roberta Caorsi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centro Specialistico Ortopedico Traumatologico Gaetano Pini - CTO</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Achille Marino</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Fondazione IRCCS Cà Granda Ospedale Maggiore Policlinico</name>
      <address>
        <city>Milano</city>
        <state>Lombardia</state>
        <zip>20122</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Giovanni Filocamo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda di Rilievo Nazionale e Alta Specializzazione Civico Di Cristina Benfratelli</name>
      <address>
        <city>Palermo</city>
        <state>Sicilia</state>
        <zip>90127</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Not yet recruiting</status>
    <investigator>
      <last_name>Maria Cristina Maggio</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Ospedaliera Spedali Civili di Brescia</name>
      <address>
        <city>Brescia</city>
        <zip>25123</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Marco Cattalini</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Azienda Sanitaria Locale n. 2 - Lanciano Vasto Chieti</name>
      <address>
        <city>Chieti</city>
        <zip>66100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Luciana Dott.ssa Breda</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Ospedale Infantile Burlo Garofolo</name>
      <address>
        <city>Trieste</city>
        <zip>34137</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alberto Tommasini</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kanazawa University Hospital</name>
      <address>
        <city>Kanazawa</city>
        <state>Ishikawa</state>
        <zip>920-8641</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>81120023812</phone>
    </contact>
    <investigator>
      <last_name>Tadafumi Yokoyama</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kanagawa Children's Medical Center</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>232-8555</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Tomoyuki Imagawa</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Yokohama City University Hospital</name>
      <address>
        <city>Yokohama</city>
        <state>Kanagawa</state>
        <zip>236-0004</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Shuichi Ito</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Miyagi Children's Hospital</name>
      <address>
        <city>Sendai</city>
        <state>Miyagi</state>
        <zip>989-3126</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Hiroaki Umebayashi</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Osaka Medical and Pharmaceutical University Hospital</name>
      <address>
        <city>Takatsuki</city>
        <state>Osaka</state>
        <zip>569-8686</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yuko Sugita</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Saitama Children's Medical Center</name>
      <address>
        <city>Saitama-shi</city>
        <state>Saitama</state>
        <zip>330 8777</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>81120023812</phone>
    </contact>
    <investigator>
      <last_name>Satoshi Sato</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tokyo Medical And Dental University Medical Hospital</name>
      <address>
        <city>Bunkyō</city>
        <state>Tokyo</state>
        <zip>113-8519</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Masaki Shimizu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Tokyo Women's Medical University Hospital</name>
      <address>
        <city>Shinjuku-ku</city>
        <state>Tokyo</state>
        <zip>162-8666</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>81120023812</phone>
    </contact>
    <investigator>
      <last_name>Takako Miyamae</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Chiba Children's Hospital</name>
      <address>
        <city>Chiba</city>
        <zip>266-0007</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Minako Tomiita</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Kagoshima University Hospital</name>
      <address>
        <city>Kagoshima</city>
        <zip>890-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Yuichi Yamasaki</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Niigata University Medical &amp; Dental Hospital</name>
      <address>
        <city>Niigata</city>
        <zip>951-8520</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Utako Kaneko</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>St. Luke's International Hospital</name>
      <address>
        <city>Tokyo</city>
        <zip>104-8560</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Completed</status>
  </location>
  <location>
    <facility>
      <name>Clinstile, S.A. de C.V.</name>
      <address>
        <city>Mexico</city>
        <state>Distrito Federal</state>
        <zip>6700</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Favio Edmundo Enriquez Sosa</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Crea de Guadalajara</name>
      <address>
        <city>Guadalajara</city>
        <state>Jalisco</state>
        <zip>44600</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Gabriel Vega Cornejo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario &quot;Dr. Jose Eleuterio Gonzalez&quot;</name>
      <address>
        <city>Monterrey</city>
        <state>Nuevo León</state>
        <zip>66460</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Nadina Rubio Perez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Investigacion y Biomedicina de Chihuahua</name>
      <address>
        <city>Chihuahua</city>
        <zip>31000</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Cesar Francisco Pacheco-Tena</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Instituto de Investigaciones Clínicas para la Salud</name>
      <address>
        <city>Durango</city>
        <zip>34000</zip>
        <country>Mexico</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Edgar Hernandez</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Narodowy Instytut Geriatrii, Reumatologii i Rehabilitacji</name>
      <address>
        <city>Warsaw</city>
        <state>Mazowieckie</state>
        <zip>02-637</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Piotr Marek Gietka</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Wojewódzki Specjalistyczny Szpital Dziecięcy im. św. Ludwika w Krakowie</name>
      <address>
        <city>Krakow</city>
        <state>Małopolskie</state>
        <zip>31-503</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Zbigniew Michal Zuber</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Centralny Szpital Kliniczny Uniwersytetu Medycznego w Lodzi</name>
      <address>
        <city>Łódź</city>
        <state>Łódzkie</state>
        <zip>91-738</zip>
        <country>Poland</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Elzbieta Smolewska</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Federal State Budgetary Scientific Institution Research Institute Rheumatology named after V.A.Nasonova</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Irina Nikishina</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Scientific Center of Children's Health</name>
      <address>
        <city>Moscow</city>
        <state>Moskva</state>
        <zip>119991</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ekaterina Alexeeva</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Sant Joan de Déu</name>
      <address>
        <city>Esplugues de Llobregat</city>
        <state>Barcelona [Barcelona]</state>
        <zip>8950</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Jordi Anton</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Infantil Universitario Niño Jesús</name>
      <address>
        <city>Madrid</city>
        <state>Madrid, Comunidad De</state>
        <zip>28009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>DANIEL CLEMENTE</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Ramón y Cajal</name>
      <address>
        <city>Madrid</city>
        <state>Madrid, Comunidad De</state>
        <zip>28034</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Alina Lucica Boteanu</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario La Paz</name>
      <address>
        <city>Madrid</city>
        <zip>28046</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Rosa Alcobendas</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitario Virgen Del Rocio</name>
      <address>
        <city>Sevilla</city>
        <zip>41013</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Marisol Camacho Lovillo</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Hospital Universitari i Politecnic La Fe</name>
      <address>
        <city>València</city>
        <zip>46026</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Inmaculada Calvo Penades</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Istanbul University-Cerrahpasa, Cerrahpasa Faculty of Medicine</name>
      <address>
        <city>Istanbul</city>
        <zip>34098</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Ozgur Kasapcopur</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>9 Eylul University Hospital</name>
      <address>
        <city>Izmir</city>
        <zip>35340</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Erbil Unsal</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Bristol Royal Hospital for Children</name>
      <address>
        <city>Bristol</city>
        <state>Bristol, City Of</state>
        <zip>BS2 8BJ</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Athimalaipet V Ramanan</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Alder Hey Children's Hospital</name>
      <address>
        <city>Liverpool</city>
        <state>England</state>
        <zip>L14 5AB</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Beverley Almeida</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>University College Hospital - London</name>
      <address>
        <city>London</city>
        <state>Greater London</state>
        <zip>W1T 7HA</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <phone>2034567890</phone>
    </contact>
    <investigator>
      <last_name>Corinne Fisher</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Great Ormond Street Hospital For Children NHS Foundation Trust</name>
      <address>
        <city>London</city>
        <state>London, City Of</state>
        <zip>WC1N 3JH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Sandrine Lacassagne</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Oxford University Hospitals - Nuffield Orthopaedic Centre</name>
      <address>
        <city>Oxford</city>
        <state>Oxfordshire</state>
        <zip>OX3 7LD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Akhila Murthy Kavirayani</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location>
    <facility>
      <name>Sheffield Children's Hospital</name>
      <address>
        <city>Sheffield</city>
        <zip>S10 2TH</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <investigator>
      <last_name>Daniel Philip Hawley</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Argentina</country>
    <country>Australia</country>
    <country>Austria</country>
    <country>Belgium</country>
    <country>Brazil</country>
    <country>China</country>
    <country>Czechia</country>
    <country>Denmark</country>
    <country>France</country>
    <country>Germany</country>
    <country>India</country>
    <country>Israel</country>
    <country>Italy</country>
    <country>Japan</country>
    <country>Mexico</country>
    <country>Poland</country>
    <country>Russian Federation</country>
    <country>Spain</country>
    <country>Turkey</country>
    <country>United Kingdom</country>
  </location_countries>
  <link>
    <url>https://trials.lillytrialguide.com/en-US/trial/1jKB0Gb6daw6sUu4gseGga</url>
    <description>A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis</description>
  </link>
  <verification_date>September 2023</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 12, 2018</study_first_posted>
  <last_update_submitted>September 13, 2023</last_update_submitted>
  <last_update_submitted_qc>September 13, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 14, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Polyarticular JIA</keyword>
  <keyword>Oligoarthritis</keyword>
  <keyword>Juvenile psoriatic arthritis (JPsA)</keyword>
  <keyword>Enthesitis-related juvenile idiopathic arthritis (ERA)</keyword>
  <keyword>Systemic JIA with and without systemic features</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
    <ipd_time_frame>Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.</ipd_time_frame>
    <ipd_access_criteria>A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.</ipd_access_criteria>
    <ipd_url>http://www.clinicalstudydatarequest.com</ipd_url>
  </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/NCT03773965
org study id: 16278
secondary id: I4V-MC-JAHX
secondary id: 2017-004471-31
nct id: NCT03773965
lead sponsor: 
has dmc: Yes
is fda regulated drug: Yes
is fda regulated device: No
The reason for this study is to see if the study drug baricitinib is safe and effective in
      the treatment of JIA in participants ages 1 to 17. This study is for participants that have
      been enrolled in studies I4V-MC-JAHV (NCT03773978) or I4V-MC-JAHU.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants with One or More Serious Adverse Event(s) (SAEs)
time frame: Baseline through Week 264
description: Number of participants with one or more SAEs
measure: Number of Participants with Permanent Investigational Product Discontinuations
time frame: Baseline through Week 264
description: Number of participants with permanent investigational product discontinuations
measure: Proportion of Participants Achieving Pediatric American College of Rheumatology 30 Responder Index (PedACR30)
time frame: Week 264
description: Proportion of participants achieving PedACR30
measure: Proportion of Participants who have Disease Flare
time frame: Baseline through Week 264
description: Proportion of participants who have disease flare
measure: Proportion of Participants with Inactive Disease
time frame: Week 264
description: Proportion of participants with inactive disease
measure: Proportion of Participants with Minimal Disease Activity
time frame: Week 264
description: Proportion of participants with minimal disease activity
measure: Proportion of Participants in Remission
time frame: Week 264
description: Proportion of participants in remission
measure: Change from Baseline in Juvenile Arthritis Disease Activity Score-27 (JADAS27)
time frame: Baseline, Week 264
description: Change from baseline of originating study in JADAS27
measure: Change from Baseline in Arthritis-Related Pain Severity as Measured by the Childhood Health Assessment Questionnaire (CHAQ) Pain Visual Analog Scale (VAS) Item
time frame: Baseline, Week 264
description: Change from baseline in arthritis-related pain severity as measured by the CHAQ pain VAS item
measure: Change from Baseline in Psoriasis Area and Severity Index (PASI)
time frame: Baseline, Week 264
description: Change from baseline in PASI
measure: Change from Baseline in Spondyloarthritis Research Consortium of Canada (SPARCC) Enthesitis Index
time frame: Baseline, Week 264
description: Change from baseline in SPARCC enthesitis index
measure: Change from Baseline in Juvenile Spondyloarthritis Disease Activity Index (JSpADA)
time frame: Baseline, Week 264
description: Change from baseline in JSpADA
measure: Change from Baseline in Immunoglobulin Levels
time frame: Baseline, Week 264
description: Change from baseline in immunoglobulin levels
measure: Change from Baseline in Immunophenotyping (T Cells)
time frame: Baseline, Week 264
description: Change from baseline in immunophenotyping (T Cells)
measure: Change of Immunoglobulin G (IgG) Titers
time frame: Pre-Vaccination to 12 Weeks Post-Vaccination
description: Change of IgG titers
arm group label: Baricitinib
arm group type: Experimental
description: Baricitinib given orally.
intervention type: Drug
intervention name: Baricitinib
description: Administered orally.
arm group label: Baricitinib
other name: LY3009104
criteria: 
gender: All
minimum age: 1 Year
maximum age: 18 Years
healthy volunteers: No
last name: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)
role: Study Director
affiliation: Eli Lilly and Company
last name: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or
phone: 1-317-615-4559
email: ClinicalTrials.gov@lilly.com
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Active, not recruiting
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Not yet recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Completed
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
contact: 
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
facility: 
status: Recruiting
investigator: 
country: Argentina
country: Australia
country: Austria
country: Belgium
country: Brazil
country: China
country: Czechia
country: Denmark
country: France
country: Germany
country: India
country: Israel
country: Italy
country: Japan
country: Mexico
country: Poland
country: Russian Federation
country: Spain
country: Turkey
country: United Kingdom
url: https://trials.lillytrialguide.com/en-US/trial/1jKB0Gb6daw6sUu4gseGga
description: A Study of Baricitinib in Participants From 1 Year to Less Than 18 Years Old With Juvenile Idiopathic Arthritis
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Juvenile
sharing ipd: Yes
ipd description: Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Clinical Study Report (CSR)
ipd time frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and EU, whichever is later. Data will be indefinitely available for requesting.
ipd access criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement.
ipd url: http://www.clinicalstudydatarequest.com