<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/NCT03784261</url>
  </required_header>
  <id_info>
    <org_study_id>NonTNF 2018</org_study_id>
    <nct_id>NCT03784261</nct_id>
  </id_info>
  <brief_title>Usefulness of Non TNF Usage in RA Patients</brief_title>
  <official_title>Usefulness of Non TNF Usage in Rheumatoid Arthritis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Shinshu University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Shinshu University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to examine the efficacy and adverse events in the following 3 groups&#xD;
      in rheumatoid arthritis patients:&#xD;
&#xD;
        1. Sarilumab treatment for 12 months&#xD;
&#xD;
        2. Tocilizmab treatment for 12 months&#xD;
&#xD;
        3. Abatacept treatment for 12 months&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">December 17, 2018</start_date>
  <completion_date type="Anticipated">December 16, 2024</completion_date>
  <primary_completion_date type="Anticipated">December 16, 2022</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change from Baseline Values of DAS28-CRP</measure>
    <time_frame>Baseline and 1 year</time_frame>
    <description>Assessment of efficacy in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Assessment of adverse event in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).</measure>
    <time_frame>at 1 year</time_frame>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>SAR, usually subucutaneous injection every 2 weeks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>TCZ, usually subucutaneous injection every 2 weeks</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <arm_group>
    <arm_group_label>ABT, usually subucutaneous injection every week</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug: &quot;Salirumab&quot;</intervention_name>
    <description>To examine the effects of salirumab in RA patients</description>
    <arm_group_label>ABT, usually subucutaneous injection every week</arm_group_label>
    <arm_group_label>SAR, usually subucutaneous injection every 2 weeks</arm_group_label>
    <arm_group_label>TCZ, usually subucutaneous injection every 2 weeks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug: &quot;Tocilizmab&quot;</intervention_name>
    <description>To examine the effects of tocilizmab in RA patients</description>
    <arm_group_label>ABT, usually subucutaneous injection every week</arm_group_label>
    <arm_group_label>SAR, usually subucutaneous injection every 2 weeks</arm_group_label>
    <arm_group_label>TCZ, usually subucutaneous injection every 2 weeks</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Drug: &quot;Abatacept&quot;</intervention_name>
    <description>To examine the effects of abatacept in RA patients</description>
    <arm_group_label>ABT, usually subucutaneous injection every week</arm_group_label>
    <arm_group_label>SAR, usually subucutaneous injection every 2 weeks</arm_group_label>
    <arm_group_label>TCZ, usually subucutaneous injection every 2 weeks</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ・RA patients&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Not RA patients&#xD;
&#xD;
          -  RA patients who are allergic to the drugs, refused to do this research, or who are&#xD;
             pregnant&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Yukio Nakamura</name>
      <address>
        <city>Matsumoto</city>
        <state>Nagano</state>
        <zip>3908621</zip>
        <country>Japan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yukio Nakamura, MD, PhD</last_name>
      <phone>+81-263-37-2659</phone>
      <email>yxn14@aol.jp</email>
    </contact>
    <investigator>
      <last_name>Yukio Nakamura, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Japan</country>
  </location_countries>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>December 17, 2018</study_first_submitted>
  <study_first_submitted_qc>December 20, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 21, 2018</study_first_posted>
  <last_update_submitted>September 20, 2021</last_update_submitted>
  <last_update_submitted_qc>September 20, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 21, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Shinshu University</investigator_affiliation>
    <investigator_full_name>Yukio Nakamura</investigator_full_name>
    <investigator_title>Principle Investigator</investigator_title>
  </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>Abatacept</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03784261
org study id: NonTNF 2018
nct id: NCT03784261
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to examine the efficacy and adverse events in the following 3 groups
      in rheumatoid arthritis patients:

        1. Sarilumab treatment for 12 months

        2. Tocilizmab treatment for 12 months

        3. Abatacept treatment for 12 months
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Change from Baseline Values of DAS28-CRP
time frame: Baseline and 1 year
description: Assessment of efficacy in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).
measure: Assessment of adverse event in rheumatoid arthritis patients for 1 year treated by salirumab (N=30), tocilizumab (N=30), or abatacept (N=30).
time frame: at 1 year
arm group label: SAR, usually subucutaneous injection every 2 weeks
arm group type: Active Comparator
arm group label: TCZ, usually subucutaneous injection every 2 weeks
arm group type: Active Comparator
arm group label: ABT, usually subucutaneous injection every week
arm group type: Active Comparator
intervention type: Drug
intervention name: Drug: "Salirumab"
description: To examine the effects of salirumab in RA patients
arm group label: ABT, usually subucutaneous injection every week
arm group label: SAR, usually subucutaneous injection every 2 weeks
arm group label: TCZ, usually subucutaneous injection every 2 weeks
intervention type: Drug
intervention name: Drug: "Tocilizmab"
description: To examine the effects of tocilizmab in RA patients
arm group label: ABT, usually subucutaneous injection every week
arm group label: SAR, usually subucutaneous injection every 2 weeks
arm group label: TCZ, usually subucutaneous injection every 2 weeks
intervention type: Drug
intervention name: Drug: "Abatacept"
description: To examine the effects of abatacept in RA patients
arm group label: ABT, usually subucutaneous injection every week
arm group label: SAR, usually subucutaneous injection every 2 weeks
arm group label: TCZ, usually subucutaneous injection every 2 weeks
criteria: 
gender: All
minimum age: 20 Years
maximum age: 100 Years
healthy volunteers: No
facility: 
status: Recruiting
contact: 
investigator: 
country: Japan
responsible party type: Principal Investigator
investigator affiliation: Shinshu University
investigator full name: Yukio Nakamura
investigator title: Principle Investigator
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Abatacept
sharing ipd: No