<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/NCT03291457</url>
  </required_header>
  <id_info>
    <org_study_id>ML39114</org_study_id>
    <nct_id>NCT03291457</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab in Daily Clinical Practice</brief_title>
  <acronym>COGNOS</acronym>
  <official_title>A Prospective Non-Interventional Study to Evaluate the Use of Glucocorticoids in Combination With Tocilizumab 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>
  <oversight_info>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This prospective, multicenter, observational study will evaluate the use of concomitant&#xD;
      glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with&#xD;
      tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks&#xD;
      after starting treatment with tocilizumab. All visits and assessments will be performed as&#xD;
      per routine clinical practice, with no study-specific visits or interventions.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2017</start_date>
  <completion_date type="Actual">December 4, 2019</completion_date>
  <primary_completion_date type="Actual">December 4, 2019</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 Who Are Able to Discontinue Use of Glucocorticoid without Loss of Disease Control According to Disease Activity Score Based on 28 Joints (DAS28)</measure>
    <time_frame>Week 52</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 50 Percent (%) or More without Loss of Disease Control According to DAS28</measure>
    <time_frame>Week 52</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Participants by Reason for Glucocorticoid Dose Modification</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Glucocorticoid Dose</measure>
    <time_frame>Baseline; Weeks 24 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 25%, 50%, 75%, or 100%</measure>
    <time_frame>Weeks 24 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%</measure>
    <time_frame>Weeks 24 and 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to First Glucocorticoid Dose Reduction</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time to Glucocorticoid Discontinuation</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants in Remission According to DAS28 Who Discontinued Glucocorticoids</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Low Disease Activity (LDA) According to DAS28 with Glucocorticoid Dose Reduction</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with LDA According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with LDA According to DAS28 Who Discontinued Glucocorticoids</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucocorticoid Dose among Participants in Remission According to DAS28</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Glucocorticoid Dose among Participants with LDA According to DAS28</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Correlation between DAS28 Score and Glucocorticoid Dose</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of Participants with Adverse Events</measure>
    <time_frame>Baseline up to Week 52</time_frame>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">101</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Glucocorticoids + Tocilizumab</arm_group_label>
    <description>Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Tocilizumab</intervention_name>
    <description>For intravenous (IV) tocilizumab, the recommended dosage is 8 milligrams per kilogram (mg/kg) once every 4 weeks. For subcutaneous (SC) tocilizumab, the recommended dosage is 162 milligrams (mg) once weekly. However, because of the observational nature of the study, dosing and treatment duration is at the discretion of the physician in accordance with local clinical practice and local labeling.</description>
    <arm_group_label>Glucocorticoids + Tocilizumab</arm_group_label>
    <other_name>RoActemra</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glucocorticoid Agent</intervention_name>
    <description>Because of the observational nature of the study, the choice of glucocorticoid agent, as well as dosing and treatment duration, is at the discretion of the physician in accordance with local clinical practice and local labeling.</description>
    <arm_group_label>Glucocorticoids + Tocilizumab</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        This study will follow participants with RA who are receiving glucocorticoids prior to&#xD;
        start of tocilizumab in daily clinical practice.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosis of moderate to severe RA, defined as DAS28 greater than or equal to 3.7&#xD;
&#xD;
          -  Naive to tocilizumab, or received tocilizumab within 8 weeks prior to enrollment&#xD;
&#xD;
          -  Physician has made decision to commence IV or SC tocilizumab in accordance with label&#xD;
             and reimbursement criteria&#xD;
&#xD;
          -  Treated with glucocorticoids for RA when starting tocilizumab treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Treatment with any investigational agent within 4 weeks or 5 half-lives before&#xD;
             tocilizumab&#xD;
&#xD;
          -  Continuous or regular treatment with oral corticosteroids for any indication other&#xD;
             than RA&#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>
      <name>ASZ Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Onze Lieve Vrouwziekenhuis Aalst</name>
      <address>
        <city>Aalst</city>
        <zip>9300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Dr. Huppertz - Marx pgmbh</name>
      <address>
        <city>Amel</city>
        <zip>4770</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice Els Van Essche</name>
      <address>
        <city>Bonheiden</city>
        <zip>2820</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Jan</name>
      <address>
        <city>Brugge</city>
        <zip>8000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU St Pierre (César de Paepe)</name>
      <address>
        <city>Bruxelles</city>
        <zip>1000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Hospital Erasme</name>
      <address>
        <city>Bruxelles</city>
        <zip>1070</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhumarc sciv sprl</name>
      <address>
        <city>Céroux-Mousty</city>
        <zip>1341</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Antwerpen</name>
      <address>
        <city>Edegem</city>
        <zip>2650</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Rhumaconsult sciv sprl; Private Practice</name>
      <address>
        <city>Forchies-la-Marche</city>
        <zip>6141</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reumacentrum Genk</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Reumaclinic</name>
      <address>
        <city>Genk</city>
        <zip>3600</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Lucas (Sint Lucas)</name>
      <address>
        <city>Gent</city>
        <zip>9000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>GHdC Site Saint-Joseph</name>
      <address>
        <city>Gilly (Charleroi)</city>
        <zip>6000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHC MontLégia</name>
      <address>
        <city>Liege</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Heilig Hartziekenhuis vzw</name>
      <address>
        <city>Lier</city>
        <zip>2500</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CHU de Liège; Rhumatologie</name>
      <address>
        <city>Liège</city>
        <zip>4000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Private Practice; Reumatologie</name>
      <address>
        <city>Mechelen</city>
        <zip>2800</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Damiaan</name>
      <address>
        <city>Oostende</city>
        <zip>8400</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Alma vzw (Sijsele)</name>
      <address>
        <city>Sijsele</city>
        <zip>8340</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Turnhout Sint Jozef</name>
      <address>
        <city>Turnhout</city>
        <zip>2300</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>AZ Sint Jozef Malle</name>
      <address>
        <city>Westmalle</city>
        <zip>2390</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>September 20, 2017</study_first_submitted>
  <study_first_submitted_qc>September 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 25, 2017</study_first_posted>
  <last_update_submitted>May 14, 2020</last_update_submitted>
  <last_update_submitted_qc>May 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 18, 2020</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glucocorticoids</mesh_term>
  </intervention_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/NCT03291457
org study id: ML39114
nct id: NCT03291457
lead sponsor: 
is fda regulated device: No
This prospective, multicenter, observational study will evaluate the use of concomitant
      glucocorticoid therapy in adults with rheumatoid arthritis (RA) being treated with
      tocilizumab in daily clinical practice. Participants will be observed for up to 52 weeks
      after starting treatment with tocilizumab. All visits and assessments will be performed as
      per routine clinical practice, with no study-specific visits or interventions.
observational model: Cohort
time perspective: Prospective
measure: Percentage of Participants Who Are Able to Discontinue Use of Glucocorticoid without Loss of Disease Control According to Disease Activity Score Based on 28 Joints (DAS28)
time frame: Week 52
measure: Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 50 Percent (%) or More without Loss of Disease Control According to DAS28
time frame: Week 52
measure: Percentage of Participants by Reason for Glucocorticoid Dose Modification
time frame: Baseline up to Week 52
measure: Glucocorticoid Dose
time frame: Baseline; Weeks 24 and 52
measure: Percentage of Participants Who Are Able to Reduce Use of Glucocorticoid by 25%, 50%, 75%, or 100%
time frame: Weeks 24 and 52
measure: Percentage of Participants in Need of Glucocorticoid Dose Increase by 25%, 50%, 75%, or 100%
time frame: Weeks 24 and 52
measure: Time to First Glucocorticoid Dose Reduction
time frame: Baseline up to Week 52
measure: Time to Glucocorticoid Discontinuation
time frame: Baseline up to Week 52
measure: Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction
time frame: Baseline up to Week 52
measure: Percentage of Participants in Remission According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%
time frame: Baseline up to Week 52
measure: Percentage of Participants in Remission According to DAS28 Who Discontinued Glucocorticoids
time frame: Baseline up to Week 52
measure: Percentage of Participants with Low Disease Activity (LDA) According to DAS28 with Glucocorticoid Dose Reduction
time frame: Baseline up to Week 52
measure: Percentage of Participants with LDA According to DAS28 with Glucocorticoid Dose Reduction of At Least 25%, 50%, or 75%
time frame: Baseline up to Week 52
measure: Percentage of Participants with LDA According to DAS28 Who Discontinued Glucocorticoids
time frame: Baseline up to Week 52
measure: Glucocorticoid Dose among Participants in Remission According to DAS28
time frame: Baseline up to Week 52
measure: Glucocorticoid Dose among Participants with LDA According to DAS28
time frame: Baseline up to Week 52
measure: Correlation between DAS28 Score and Glucocorticoid Dose
time frame: Baseline up to Week 52
measure: Percentage of Participants with Adverse Events
time frame: Baseline up to Week 52
arm group label: Glucocorticoids + Tocilizumab
description: Participants with RA who are receiving glucocorticoid treatment will be observed for up to 52 weeks after starting tocilizumab.
intervention type: Drug
intervention name: Tocilizumab
description: For intravenous (IV) tocilizumab, the recommended dosage is 8 milligrams per kilogram (mg/kg) once every 4 weeks. For subcutaneous (SC) tocilizumab, the recommended dosage is 162 milligrams (mg) once weekly. However, because of the observational nature of the study, dosing and treatment duration is at the discretion of the physician in accordance with local clinical practice and local labeling.
arm group label: Glucocorticoids + Tocilizumab
other name: RoActemra
intervention type: Drug
intervention name: Glucocorticoid Agent
description: Because of the observational nature of the study, the choice of glucocorticoid agent, as well as dosing and treatment duration, is at the discretion of the physician in accordance with local clinical practice and local labeling.
arm group label: Glucocorticoids + Tocilizumab
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
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country: Belgium
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Glucocorticoids