<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/NCT01727986</url>
  </required_header>
  <id_info>
    <org_study_id>ML28413</org_study_id>
    <nct_id>NCT01727986</nct_id>
  </id_info>
  <brief_title>An Extension Long-Term Study of RoActemra/Actemra (Tocilizumab) in Patients With Polyarticular Juvenile Idiopathic Arthritis Who Completed The WA19977 Study</brief_title>
  <official_title>Extension, Open-label, Interventional, Long-term Study to Evaluate the Safety of Tocilizumab Treatment in Patients From Brazil With Polyarticular-course Juvenile Idiopathic Arthritis Who Completed the Global Multinational Trial (WA19977)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hoffmann-La Roche</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hoffmann-La Roche</source>
  <brief_summary>
    <textblock>
      This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra&#xD;
      (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who&#xD;
      completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical&#xD;
      response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra&#xD;
      8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">November 2015</completion_date>
  <primary_completion_date type="Actual">November 2015</primary_completion_date>
  <phase>Phase 3</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Long-term safety: Incidence of adverse events</measure>
    <time_frame>approximately 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Response rates according to the American College of Rheumatology criteria for juvenile idiopathic arthritis (JIA ACR)</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients achieving inactive disease/clinical remission</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">11</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <arm_group>
    <arm_group_label>RoActemra/Actemra</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>tocilizumab [RoActemra/Actemra]</intervention_name>
    <description>8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks</description>
    <arm_group_label>RoActemra/Actemra</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients 9 to 18 years of age who completed visit 33 (week 104) of WA19977 study with&#xD;
             at least JIA ACR30 clinical response to RoActemra/Actemra relative to baseline in&#xD;
             WA19977, with no AEs, SAEs or conditions that lead to unacceptable risk of continued&#xD;
             treatment&#xD;
&#xD;
          -  Females of child-bearing potential and males with female partners of child-bearing&#xD;
             potential must agree to use effective contraception as defined by protocol&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with, according to investigator judgment, not satisfactory benefit from&#xD;
             RoActemra/Actemra therapy within WA19977&#xD;
&#xD;
          -  Treatment with any investigational agent since the last administration of study drug&#xD;
             in the core study WA19977 or current participation in another clinical trial except&#xD;
             WA19977&#xD;
&#xD;
          -  Patient developed any other autoimmune rheumatic disease or overlap syndrome other&#xD;
             than the permitted polyarticular-course JIA subsets: rheumatoid factor positive or&#xD;
             negative JIA or extended oligoarticular JIA&#xD;
&#xD;
          -  Patient is pregnant , lactating, or intending to become pregnant during the study and&#xD;
             up to 12 weeks after the last administration of study drug&#xD;
&#xD;
          -  Any significant concomitant disease or medical or surgical condition&#xD;
&#xD;
          -  History of significant allergic or infusion reactions to prior biologic therapy&#xD;
&#xD;
          -  Currently active primary or secondary immunodeficiency&#xD;
&#xD;
          -  Current abuse of alcohol, drugs or chemical abuse&#xD;
&#xD;
          -  Known and currently active acute, subacute, chronic infections or history of recurrent&#xD;
             infection; patients suffering from ongoing active infections with Epstein Barr virus,&#xD;
             herpes zoster or recurrent history of urinary tract infection can be included after&#xD;
             the (acute) infection has been excluded or subsided&#xD;
&#xD;
          -  Positive for latent tuberculosis (TB)&#xD;
&#xD;
          -  Currently active asthma for which the patient has required the use of oral or&#xD;
             parenteral corticosteroids for &gt;/= 2 weeks within 6 months prior to entering the study&#xD;
&#xD;
          -  Inadequate hepatic, renal or bone marrow function&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Rio de janeiro</city>
        <state>RJ</state>
        <zip>20551030</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Rio de Janeiro</city>
        <state>RJ</state>
        <zip>21941-912</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Porto Alegre</city>
        <state>RS</state>
        <zip>90035-003</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sao Paulo</city>
        <state>SP</state>
        <zip>05403-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>November 8, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 16, 2012</study_first_posted>
  <last_update_submitted>May 4, 2016</last_update_submitted>
  <last_update_submitted_qc>May 4, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 5, 2016</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>Arthritis</mesh_term>
    <mesh_term>Arthritis, Juvenile</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/NCT01727986
org study id: ML28413
nct id: NCT01727986
lead sponsor: 
This long-term, open-label extension study will evaluate the safety of RoActemra/Actemra
      (tocilizumab) in patients with polyarticular-course juvenile idiopathic arthritis who
      completed the WA19977 core study. Patients aged 9-18 years with at least JIA ACR30 clinical
      response to RoActemra/Actemra in the core study will be eligible to receive RoActemra/Actemra
      8 mg/kg intravenously every 4 weeks. Anticipated time on study treatment is 104 weeks.
primary purpose: Treatment
masking: None (Open Label)
measure: Long-term safety: Incidence of adverse events
time frame: approximately 3 years
measure: Response rates according to the American College of Rheumatology criteria for juvenile idiopathic arthritis (JIA ACR)
time frame: approximately 3 years
measure: Proportion of patients achieving inactive disease/clinical remission
time frame: approximately 3 years
arm group label: RoActemra/Actemra
arm group type: Experimental
intervention type: Drug
intervention name: tocilizumab [RoActemra/Actemra]
description: 8 mg/kg or 10 mg/kg iv every 4 weeks, 104 weeks
arm group label: RoActemra/Actemra
criteria: 
gender: All
minimum age: 9 Years
maximum age: 18 Years
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
facility: 
facility: 
country: Brazil
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Juvenile