<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/NCT03264703</url>
  </required_header>
  <id_info>
    <org_study_id>D2E7-M082-601</org_study_id>
    <nct_id>NCT03264703</nct_id>
  </id_info>
  <brief_title>Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus ANti-TNF Versus cDMARDs in Real World</brief_title>
  <acronym>HUMAN</acronym>
  <official_title>An Observational Study in Patients With Moderated to Severe Rheumatoid Arthritis Who Have Failed to Combination Therapy of Conventional Disease-modifying Antirheumatic Drugs (cDMARDs) to cDMARD Plus Anti-TNF Versus cDMARDs in Real World [&quot;HUMAN&quot; Study]</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Eisai Korea Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Eisai Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will be conducted to observe the disease activity change of Conventional Disease&#xD;
      Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from&#xD;
      baseline to 6 months compared with cDMARDs, as measured by the disease activity score with&#xD;
      the erythrocyte sedimentation rate (DAS28-ESR).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 11, 2017</start_date>
  <completion_date type="Actual">July 17, 2019</completion_date>
  <primary_completion_date type="Actual">July 17, 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>Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6</measure>
    <time_frame>Baseline; Month 6</time_frame>
    <description>DAS28 is a quantitative tool used to measure and monitor disease activity and &quot;the treatment&quot; of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the DAS28-ESR at Month 3</measure>
    <time_frame>Baseline; Month 3</time_frame>
    <description>DAS28 is a quantitative tool used to measure and monitor disease activity and &quot;the treatment&quot; of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change from Baseline in the DAS28-ESR at Month 12</measure>
    <time_frame>Baseline; Month 12</time_frame>
    <description>DAS28 is a quantitative tool used to measure and monitor disease activity and &quot;the treatment&quot; of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical remission rate measured by DAS28-ESR</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Clinical remission is defined as no tender or swollen joints and a normal erythrocyte sedimentation rate. DAS28 will be used to measure disease activity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Success rates of dose-reduction and discontinuation of steroid(s)</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>Dose reduction is defined as a reduction by more than 50% compared to baseline.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life</measure>
    <time_frame>Up to 12 months</time_frame>
    <description>The KHAQ-20 is a participant-assessed measure of health assessment comprised of 8 indices. Scores for each index range from 0 (no difficulty to do) to 3 (unable to do). The total score is a sum of the 8 index score and ranges from 0 to 24. Higher scores indicate more severe disease.</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">212</enrollment>
  <condition>Arthritis, Rheumatoid</condition>
  <arm_group>
    <arm_group_label>Participants with RA with cDMARD, but no anti-TNF experience</arm_group_label>
    <description>Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Male and female participants diagnosed with rheumatoid arthritis (RA), who have no&#xD;
        experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more&#xD;
        Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least&#xD;
        3 months.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Diagnosed with rheumatoid arthritis within 3 years&#xD;
&#xD;
          -  Participants who have no experience with anti-tumor necrosis factor (anti-TNF)&#xD;
&#xD;
          -  Participants who have experienced two or more Conventional Disease Modifying&#xD;
             Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months prior to&#xD;
             informed consent&#xD;
&#xD;
          -  Participants who change the treatment regimen to one of the following according to the&#xD;
             opinion of the investigator:&#xD;
&#xD;
               1. One cDMARD plus anti-TNF&#xD;
&#xD;
               2. Two or more cDMARDs: Modifications or additions of cDMARDs that have been treated&#xD;
                  prior to informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants who may be pregnant or lactating women&#xD;
&#xD;
          -  Participants who have contraindication to anti-TNF&#xD;
&#xD;
          -  Participants who had participated in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Eisai Trial Site # 1</name>
      <address>
        <city>Ilsan</city>
        <state>Gyeonggi-do</state>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 1</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 2</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 3</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 4</name>
      <address>
        <city>Busan</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 1</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 2</name>
      <address>
        <city>Daegu</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 1</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 2</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 3</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 4</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 5</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 6</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 7</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Eisai Trial Site # 8</name>
      <address>
        <city>Seoul</city>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>March 2020</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>December 14, 2020</last_update_submitted>
  <last_update_submitted_qc>December 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">December 16, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Joint pain</keyword>
  <keyword>Joint stiffness</keyword>
  <keyword>Joint redness</keyword>
  <keyword>Loss of joint function</keyword>
  <keyword>Swollen joints</keyword>
  <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/NCT03264703
org study id: D2E7-M082-601
nct id: NCT03264703
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
This study will be conducted to observe the disease activity change of Conventional Disease
      Modifying Anti-Rheumatic Drugs (cDMARD) plus anti-tumour necrosis factor (anti-TNF) from
      baseline to 6 months compared with cDMARDs, as measured by the disease activity score with
      the erythrocyte sedimentation rate (DAS28-ESR).
observational model: Cohort
time perspective: Prospective
measure: Change from Baseline in the disease activity score 28-erythrocyte sedimentation rate DAS28-ESR at Month 6
time frame: Baseline; Month 6
description: DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
measure: Change from Baseline in the DAS28-ESR at Month 3
time frame: Baseline; Month 3
description: DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
measure: Change from Baseline in the DAS28-ESR at Month 12
time frame: Baseline; Month 12
description: DAS28 is a quantitative tool used to measure and monitor disease activity and "the treatment" of rheumatoid arthritis. DAS28 uses a formula that includes the number of tender joints and swollen joints for a maximum of 28 joints. DAS28 is used to assess whether an individual participant has a significant improvement of the disease activity, compared to baseline. A DAS28 score greater than 5.1 implies active disease, a score less than 3.2 implies low disease activity, and a score less than 2.6 implies remission.
measure: Clinical remission rate measured by DAS28-ESR
time frame: Up to 12 months
description: Clinical remission is defined as no tender or swollen joints and a normal erythrocyte sedimentation rate. DAS28 will be used to measure disease activity.
measure: Success rates of dose-reduction and discontinuation of steroid(s)
time frame: Up to 12 months
description: Dose reduction is defined as a reduction by more than 50% compared to baseline.
measure: Scores on the Korean Health Assessment Questionnaire (KHAQ-20), as a measure of quality of life
time frame: Up to 12 months
description: The KHAQ-20 is a participant-assessed measure of health assessment comprised of 8 indices. Scores for each index range from 0 (no difficulty to do) to 3 (unable to do). The total score is a sum of the 8 index score and ranges from 0 to 24. Higher scores indicate more severe disease.
arm group label: Participants with RA with cDMARD, but no anti-TNF experience
description: Male and female participants diagnosed with rheumatoid arthritis (RA), who have no experience with anti-tumor necrosis factor (anti-TNF) and who have experienced two or more Conventional Disease Modifying Anti-Rheumatic Drugs (cDMARDs) of a stable dose for at least 3 months.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid