<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/NCT01667458</url>
  </required_header>
  <id_info>
    <org_study_id>ML25702</org_study_id>
    <nct_id>NCT01667458</nct_id>
  </id_info>
  <brief_title>An Observational Study on Fatigue in Patients With Rheumatoid Arthritis Treated With RoActemra/Actemra (Tocilizumab)</brief_title>
  <official_title>F-ACT Trial: Observational Study on Fatigue and Its Evolution During Treatment With Tocilizumab in Patients With Moderate to Severe Rheumatoid Arthritis in Daily Clinical Practice</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 observational study will evaluate the presence and evolution of fatigue on treatment&#xD;
      with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis&#xD;
      who have an inadequate response to at least two DMARDs (one of them methotrexate) or to&#xD;
      anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg&#xD;
      intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>September 2011</start_date>
  <completion_date type="Actual">December 2012</completion_date>
  <primary_completion_date type="Actual">December 2012</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>Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16</measure>
    <time_frame>16 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue</measure>
    <time_frame>16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Score DAS28</measure>
    <time_frame>16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain: Visual Analogue Scale VAS Pain</measure>
    <time_frame>16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Functional disability: Health Assessment Questionnaire HAQ</measure>
    <time_frame>16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of sleep: VAS</measure>
    <time_frame>16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anemia: Haemoglobin levels</measure>
    <time_frame>16 months</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression: Beck Depression Inventory (BDI) questionnaire</measure>
    <time_frame>16 months</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">59</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Cohort</arm_group_label>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients with moderate to severe rheumatoid arthritis with an inadequate response to at&#xD;
        least two DMARDs or an inadequate response to anti-TNF treatment, eligible for treatment&#xD;
        with RoActemra/Actemra&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients, &gt;/= 18 years of age&#xD;
&#xD;
          -  Moderate to severe active rheumatoid arthritis, defined as DAS28 &gt;/= 3.7&#xD;
&#xD;
          -  Inadequate clinical response to current treatment with &gt;/= 2 non-biologic DMARDs, 1 of&#xD;
             them being methotrexate optimally administered for &gt;/= 3 months, or inadequate&#xD;
             clinical response to anti-TNF therapy&#xD;
&#xD;
          -  Eligible for RoActemra/Actemra treatment in daily clinical practice&#xD;
&#xD;
          -  Absence of evolutive tuberculosis (TB)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Hypersensitivity to tocilizumab or any of the excipients&#xD;
&#xD;
          -  Active, severe infections&#xD;
&#xD;
          -  Pregnant or lactating women&#xD;
&#xD;
          -  Participation in any other interventional study&#xD;
&#xD;
          -  Patients with major depression&#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>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Assebroek</city>
        <zip>8310</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Ath</city>
        <zip>7800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Bruxelles</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Dinant</city>
        <zip>5500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Gilly (Charleroi)</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Kortrijk</city>
        <zip>8500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Lier</city>
        <zip>2500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Mons</city>
        <zip>7000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Namur</city>
        <zip>5000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Roeselare</city>
        <zip>8800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Seraing</city>
        <zip>4100</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sijsele</city>
        <zip>8340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Turnhout</city>
        <zip>2300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Verviers</city>
        <zip>4800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Waremme</city>
        <zip>4300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Westmalle</city>
        <zip>2390</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Luxembourg</city>
        <zip>2763</zip>
        <country>Luxembourg</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
    <country>Luxembourg</country>
  </location_countries>
  <verification_date>November 2016</verification_date>
  <study_first_submitted>August 15, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 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/NCT01667458
org study id: ML25702
nct id: NCT01667458
lead sponsor: 
This observational study will evaluate the presence and evolution of fatigue on treatment
      with RoActemra/Actemra (tocilizumab) in patients with moderate to severe rheumatoid arthritis
      who have an inadequate response to at least two DMARDs (one of them methotrexate) or to
      anti-TNF treatment. Patients initiated on treatment with RoActemra/Actemra (8 mg/kg
      intravenously every 4 weeks) with or without methotrexate will be followed for 4 months.
observational model: Cohort
time perspective: Prospective
measure: Evolution of fatigue: Proportion of patients meeting the Minimally Clinically Important Difference (MCID) for the Visual Analogue Sale VAS Fatigue at Week 16
time frame: 16 months
measure: Fatigue: VAS Fatigue/FACIT Fatigue/Pass Fatigue
time frame: 16 months
measure: Disease Activity Score DAS28
time frame: 16 months
measure: Pain: Visual Analogue Scale VAS Pain
time frame: 16 months
measure: Functional disability: Health Assessment Questionnaire HAQ
time frame: 16 months
measure: Quality of sleep: VAS
time frame: 16 months
measure: Anemia: Haemoglobin levels
time frame: 16 months
measure: Depression: Beck Depression Inventory (BDI) questionnaire
time frame: 16 months
arm group label: Cohort
study pop: 
sampling method: 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
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country: Belgium
country: Luxembourg
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid