<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/NCT02234960</url>
  </required_header>
  <id_info>
    <org_study_id>ML29444</org_study_id>
    <nct_id>NCT02234960</nct_id>
  </id_info>
  <brief_title>Local, Non-Interventional Study of RoActemra (Tocilizumab) in Poland (ACT-POL): First-Line Treatment in Routine Clinical Practice of Participants With Rheumatoid Arthritis (RA)</brief_title>
  <official_title>TOCILIZUMAB IN FIRST LINE BIOLOGIC TREATMENT OF PATIENTS WITH RHEUMATOID ARTHRITIS IN ROUTINE CLINICAL PRACTICE IN POLAND - MULTICENTER, NON-INTERVENTIONAL, PROSPECTIVE, OBSERVATIONAL STUDY (ACT-POL)</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>
      The aim of this non-interventional, prospective, observational study is to assess the&#xD;
      effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic&#xD;
      treatment in participants with moderate to severe active RA who are inadequate responders to&#xD;
      disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to DMARDs,&#xD;
      in a routine clinical practice setting in Poland. The length of the entire study will be 24&#xD;
      months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">July 2016</completion_date>
  <primary_completion_date type="Actual">July 2016</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>Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 &lt; 2.6) After 6 Months of Treatment</measure>
    <time_frame>Month 6</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 &lt;/= 3.2) After 6 Months of Treatment</measure>
    <time_frame>Month 6</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Discontinuation</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline</measure>
    <time_frame>Baseline</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Remission (DAS28 &lt;2.6) and Low Disease Activity (DAS28 &lt;/= 3.2) After 3 Months of Treatment</measure>
    <time_frame>Month 3</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in DAS28 Over Time</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change From Baseline in C-Reactive Protein (CRP) Over Time</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Discontinuations Due to Lack of Efficacy</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)</measure>
    <time_frame>Baseline up to Month 6</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">102</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Cohort of RA Participants</arm_group_label>
    <description>Participants with RA treated with tocilizumab at a dose and duration at the discretion of physician in accordance with the summary of product characteristics as per routine clinical practice were observed for a period of 6 months with the length of entire study for 24 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tocilizumab</intervention_name>
    <description>Tocilizumab will be given according to summary of product characteristics as per clinical practice.</description>
    <arm_group_label>Cohort of RA Participants</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Participants with a diagnosis of moderate to severe RA who are inadequate responders to&#xD;
        DMARDs, or participants who are intolerant to DMARDs, in a routine clinical practice&#xD;
        setting in Poland.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  participants at least 18 years of age&#xD;
&#xD;
          -  a diagnosis of moderate to severe RA&#xD;
&#xD;
          -  treating physician has made the decision to commence tocilizumab in first line&#xD;
             biologic treatment (population of DMARDs inadequate responders or participants who are&#xD;
             intolerant to DMARDs) in a routine clinical practice in Poland&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        N/A&#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>Bydgoszcz</city>
        <zip>85-168</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bydgoszcz</city>
        <zip>85-681</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bytom</city>
        <zip>41-902</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Krakow</city>
        <zip>30-119</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kraków</city>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lublin</city>
        <zip>20-954</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Olsztyn</city>
        <zip>10-045</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Poznań</city>
        <zip>61-285</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sieradz</city>
        <zip>98-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sopot</city>
        <zip>81-759</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Srem</city>
        <zip>63-100</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Starachowice</city>
        <zip>27-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sucha Beskidzka</city>
        <zip>34-200</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ustroń</city>
        <zip>43-450</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Wrocław</city>
        <zip>50-981</zip>
        <country>Poland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Poland</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>September 5, 2014</study_first_submitted>
  <study_first_submitted_qc>September 5, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 9, 2014</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/NCT02234960
org study id: ML29444
nct id: NCT02234960
lead sponsor: 
The aim of this non-interventional, prospective, observational study is to assess the
      effectiveness and tolerability of RoActemra (tocilizumab) used as a first-line biologic
      treatment in participants with moderate to severe active RA who are inadequate responders to
      disease-modifying antirheumatic drugs (DMARDs), or participants who are intolerant to DMARDs,
      in a routine clinical practice setting in Poland. The length of the entire study will be 24
      months.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants With Remission as Assessed by Disease Activity Score 28 (DAS28 < 2.6) After 6 Months of Treatment
time frame: Month 6
measure: Percentage of Participants with Low Disease Activity as Assessed by DAS28 (DAS28 </= 3.2) After 6 Months of Treatment
time frame: Month 6
measure: Change from Baseline in Erythrocyte Sedimentation Rate (ESR) Over Time
time frame: Baseline up to Month 6
measure: Time to Discontinuation
time frame: Baseline up to Month 6
measure: Percentage of Participants With Monotherapy Versus Combination Therapy with Methotrexate
time frame: Baseline up to Month 6
measure: Percentage of Participants With Systemic Symptoms at Baseline Versus Without Systemic Symptoms at Baseline
time frame: Baseline
measure: Percentage of Participants with Remission (DAS28 <2.6) and Low Disease Activity (DAS28 </= 3.2) After 3 Months of Treatment
time frame: Month 3
measure: Change From Baseline in DAS28 Over Time
time frame: Baseline up to Month 6
measure: Change From Baseline in C-Reactive Protein (CRP) Over Time
time frame: Baseline up to Month 6
measure: Percentage of Participants With Discontinuations Due to Lack of Efficacy
time frame: Baseline up to Month 6
measure: Percentage of Participants With Adverse Events (AEs) Or Serious AEs (SAEs)
time frame: Baseline up to Month 6
arm group label: Cohort of RA Participants
description: Participants with RA treated with tocilizumab at a dose and duration at the discretion of physician in accordance with the summary of product characteristics as per routine clinical practice were observed for a period of 6 months with the length of entire study for 24 months.
intervention type: Drug
intervention name: Tocilizumab
description: Tocilizumab will be given according to summary of product characteristics as per clinical practice.
arm group label: Cohort of RA Participants
study pop: 
sampling method: Non-Probability Sample
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: 
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country: Poland
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid