<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/NCT01730456</url>
  </required_header>
  <id_info>
    <org_study_id>ML28133</org_study_id>
    <nct_id>NCT01730456</nct_id>
  </id_info>
  <brief_title>A Long-Term Extension Study of RoActemra/Actemra (Tocilizumab) in Patients With Early Moderate to Severe Rheumatoid Arthritis Who Completed Study WA19926</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 multicenter, open-label, single arm, long-term extension study will evaluate the safety&#xD;
      and efficacy of RoActemra/Actemra (tocilizumab) in patients with early moderate to severe&#xD;
      rheumatoid arthritis who completed the WA19926 core study. Patients will receive&#xD;
      RoActemra/Actemra 8 mg/kg intravenously every 4 weeks for up to 104 weeks.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>October 2012</start_date>
  <completion_date type="Actual">May 2015</completion_date>
  <primary_completion_date type="Actual">May 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>Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)</measure>
    <time_frame>from baseline to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in total tender joint count (TJC) / swollen joint count (SJC)</measure>
    <time_frame>from baseline to Week 104</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients achieving sustained drug-free remission, defined as clinical remission based on DAS28-ESR &lt;2.6 and/or SDAI &lt;/=3 for two consecutive visits (every 12 weeks) followed by RoActemra/Actemra discontinuation after the 2nd visit</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to rheumatoid arthritis flare in patients who have entered drug-free remission</measure>
    <time_frame>approximately 3 years</time_frame>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">13</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, up to 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;
          -  Receiving treatment on an outpatient basis&#xD;
&#xD;
          -  Females of childbearing potential must agree to use at least one adequate method of&#xD;
             contraception, including a method with a failure rate of &lt;1% per year, during the&#xD;
             treatment period&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Patients who have prematurely withdrawn from the WA19926 core study for any reason&#xD;
&#xD;
          -  Treatment with an investigational agent or cell-depleting therapies since the last&#xD;
             administration of study drug in the WA19926 core study&#xD;
&#xD;
          -  Immunization with a live/attenuated vaccine since the last administration of study&#xD;
             drug in the WA19926 core study&#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;
          -  Inadequate liver, hematologic or renal function&#xD;
&#xD;
          -  History of severe allergic or anaphylactic reactions to humanized or murine monoclonal&#xD;
             antibodies&#xD;
&#xD;
          -  Known active or history of recurrent infections&#xD;
&#xD;
          -  Evidence of active malignant disease, malignancies within the previous 10 years&#xD;
             (except for basal cell carcinoma of the skin that has been excised and cured), or&#xD;
             breast cancer diagnosed within the previous 20 years&#xD;
&#xD;
          -  Uncontrolled disease states, such as asthma or inflammatory bowel disease, where&#xD;
             flares are commonly treated with oral or parenteral corticosteroids&#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>Skopje</city>
        <zip>1000</zip>
        <country>Macedonia, The Former Yugoslav Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Macedonia, The Former Yugoslav Republic of</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>November 15, 2012</study_first_submitted>
  <study_first_submitted_qc>November 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 21, 2012</study_first_posted>
  <last_update_submitted>November 1, 2016</last_update_submitted>
  <last_update_submitted_qc>November 1, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 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>
  <!-- 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/NCT01730456
org study id: ML28133
nct id: NCT01730456
lead sponsor: 
This multicenter, open-label, single arm, long-term extension study will evaluate the safety
      and efficacy of RoActemra/Actemra (tocilizumab) in patients with early moderate to severe
      rheumatoid arthritis who completed the WA19926 core study. 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: Change in disease activity: Disease Activity Score 28 - erythrocyte sedimentation rate (DAS28-ESR) and/or Simplified Disease Activity Index (SDAI)
time frame: from baseline to Week 104
measure: Change in total tender joint count (TJC) / swollen joint count (SJC)
time frame: from baseline to Week 104
measure: Proportion of patients achieving sustained drug-free remission, defined as clinical remission based on DAS28-ESR <2.6 and/or SDAI </=3 for two consecutive visits (every 12 weeks) followed by RoActemra/Actemra discontinuation after the 2nd visit
time frame: approximately 3 years
measure: Time to rheumatoid arthritis flare in patients who have entered drug-free 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 iv every 4 weeks, up to 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: 
country: Macedonia, The Former Yugoslav Republic of
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid