<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/NCT01664598</url>
  </required_header>
  <id_info>
    <org_study_id>ML28124</org_study_id>
    <nct_id>NCT01664598</nct_id>
  </id_info>
  <brief_title>An Extension Study of WA19926 of the Long-Term Safety of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis</brief_title>
  <official_title>A Multicenter, Open-label, Single Arm, Long Term Extension Study of WA19926 to Describe Safety During Treatment With Tocilizumab in Patients With Early, Moderate to Severe Rheumatoid Arthritis</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 open-label, single arm, multicenter long-term extension study of WA19926 will evaluate&#xD;
      the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to&#xD;
      severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible&#xD;
      patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104&#xD;
      weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>May 2012</start_date>
  <completion_date type="Actual">June 2015</completion_date>
  <primary_completion_date type="Actual">June 2015</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>Long-term safety: Incidence of adverse events</measure>
    <time_frame>approximately 3 years</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Efficacy according to DAS28-ESR/SDAI/TJC/SJC</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Sustained drug-free remission according to DAS28-ESR/SDAI remission criteria</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">49</enrollment>
  <condition>Rheumatoid 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 iv every 4 weeks, 104 weeks</description>
    <arm_group_label>RoActemra/Actemra</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Patients who complete their last WA19926 core study visit (Week 104) and who may&#xD;
             benefit from study drug treatment according to the Investigator's assessment&#xD;
&#xD;
          -  No current or recent adverse event or laboratory finding preventing the use of the&#xD;
             study drug dose of RoActemra/Actemra 8 mg/kg at baseline visit&#xD;
&#xD;
          -  Women of childbearing potential must agree to use adequate contraception as defined by&#xD;
             protocol during the treatment period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant females&#xD;
&#xD;
          -  Patients who have withdrawn prematurely from the WA19926 core study for any reason&#xD;
&#xD;
          -  Treatment with any investigational agent or cell-depleting therapies since the last&#xD;
             administration of study drug in WA19926&#xD;
&#xD;
          -  Treatment with an anti-tumor necrosis factor (TNF) or anti-interleukin (IL) 1 agent,&#xD;
             or a T-cell costimulation modulator since the last administration of study drug in&#xD;
             WA19926&#xD;
&#xD;
          -  Immunization with a live/attenuated vaccine since the last administration of study&#xD;
             drug in WA19926&#xD;
&#xD;
          -  Diagnosis since last WA19926 visit (Week 104) of rheumatic autoimmune disease other&#xD;
             than rheumatoid arthritis&#xD;
&#xD;
          -  Diagnosis since last WA19926 visit (Week 104) of inflammatory joint disease other than&#xD;
             rheumatoid arthritis&#xD;
&#xD;
          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal&#xD;
             antibodies, including tocilizumab and its excipients&#xD;
&#xD;
          -  Evidence of severe uncontrolled concomitant disease or disorder&#xD;
&#xD;
          -  Known active or history of recurrent infections&#xD;
&#xD;
          -  Active tuberculosis requiring treatment in the previous 3 years&#xD;
&#xD;
          -  History of alcohol, drug or chemical abuse since inclusion in the WA19926 study&#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>Clinical Trials</last_name>
    <role>Study Director</role>
    <affiliation>Hoffmann-La Roche</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Ekaterinburg</city>
        <zip>620102</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <zip>105203</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <zip>115522</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <zip>115682</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <zip>119049</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Moscow</city>
        <zip>129327</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ryazan</city>
        <zip>390011</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saint-Petersburg</city>
        <zip>195067</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Saratov</city>
        <zip>410002</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Tula</city>
        <zip>300053</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Voronezh</city>
        <zip>394066</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Yaroslavl</city>
        <zip>150030</zip>
        <country>Russian Federation</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Russian Federation</country>
  </location_countries>
  <verification_date>August 2016</verification_date>
  <study_first_submitted>August 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 10, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 14, 2012</study_first_posted>
  <last_update_submitted>August 1, 2016</last_update_submitted>
  <last_update_submitted_qc>August 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 2, 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, Rheumatoid</mesh_term>
  </condition_browse>
  <pending_results>
    <submitted>July 6, 2017</submitted>
    <returned>November 29, 2017</returned>
    <submitted>March 9, 2023</submitted>
  </pending_results>
  <!-- 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/NCT01664598
org study id: ML28124
nct id: NCT01664598
lead sponsor: 
This open-label, single arm, multicenter long-term extension study of WA19926 will evaluate
      the safety and efficacy of RoActemra/Actemra (tocilizumab) in patients with moderate to
      severe rheumatoid arthritis who have completed the 104-week WA19926 core study. Eligible
      patients will receive RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104
      weeks.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Long-term safety: Incidence of adverse events
time frame: approximately 3 years
measure: Efficacy according to DAS28-ESR/SDAI/TJC/SJC
time frame: approximately 3 years
measure: Sustained drug-free remission according to DAS28-ESR/SDAI remission criteria
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 iv every 4 weeks, 104 weeks
arm group label: RoActemra/Actemra
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Clinical Trials
role: Study Director
affiliation: Hoffmann-La Roche
facility: 
facility: 
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facility: 
facility: 
facility: 
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country: Russian Federation
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
submitted: July 6, 2017
returned: November 29, 2017
submitted: March 9, 2023