<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/NCT04472390</url>
  </required_header>
  <id_info>
    <org_study_id>201911037RIND</org_study_id>
    <nct_id>NCT04472390</nct_id>
  </id_info>
  <brief_title>Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients</brief_title>
  <official_title>Study of Tapering and Discontinuing Biological DMARDs in Rheumatoid Arthritis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Taiwan University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Taiwan University Hospital</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to analyses time to disease relapse of RA patients if TNF-α inhibitors are&#xD;
      being tapered, the predictive factors that are associated with successful taper of TNF-α&#xD;
      inhibitors. Also, investigate the effects associated with dose tapering of TNF-α inhibitors.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">December 3, 2019</start_date>
  <completion_date type="Anticipated">December 2021</completion_date>
  <primary_completion_date type="Anticipated">December 2021</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>time to disease relapse</measure>
    <time_frame>hrough study completion, an average of 10 year</time_frame>
    <description>me to relapse after tapering or discontinuing TNF-α inhibitors</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">400</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Tapering</arm_group_label>
    <description>TNF-α inhibitors</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Discontinuing</arm_group_label>
    <description>TNF-α inhibitors</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        There are 90 patients included in this cohort study, 89 patients underwent tapering of&#xD;
        TNF-α inhibitors.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion criteria:&#xD;
&#xD;
        Diagnosed of RA based on the 1987 American College of Rheumatology (ACR) criteria and/or&#xD;
        2010 ACR/EULAR classification criteria of RA depending on the time of diagnosis Age ≥ 20&#xD;
        years old TNF-α inhibitors was prescribed for RA patients refractory to csDMARDs (defined&#xD;
        as csDMARD therapy for over 6 months) during 2003/5/2 - 2017/4/30 Dose reduction or&#xD;
        discontinuation use of TNF-α inhibitors (2011/1/1-2019/4/30)&#xD;
&#xD;
        Exclusion criteria:&#xD;
&#xD;
        TNF-α inhibitors were discontinued or tapered due to adverse events such as infection,&#xD;
        liver transaminase elevation, malignancy and neutropenia.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yen-Hui Chen</last_name>
    <role>Principal Investigator</role>
    <affiliation>NTU Clinical Pharmacy School</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Yen-Hui Chen</last_name>
    <phone>33668790</phone>
    <email>tcyhchen@ntu.edu.tw</email>
  </overall_contact>
  <location>
    <facility>
      <name>National Taiwan University Hospital</name>
      <address>
        <city>Taipei</city>
        <state>Zhongzheng District</state>
        <zip>100</zip>
        <country>Taiwan</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yen-Hui Chen</last_name>
      <phone>33668790</phone>
      <email>tcyhchen@ntu.edu.tw</email>
    </contact>
  </location>
  <location_countries>
    <country>Taiwan</country>
  </location_countries>
  <verification_date>December 2019</verification_date>
  <study_first_submitted>July 8, 2020</study_first_submitted>
  <study_first_submitted_qc>July 13, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 15, 2020</study_first_posted>
  <last_update_submitted>July 13, 2020</last_update_submitted>
  <last_update_submitted_qc>July 13, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 15, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>biological DMARDs</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/NCT04472390
org study id: 201911037RIND
nct id: NCT04472390
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to analyses time to disease relapse of RA patients if TNF-α inhibitors are
      being tapered, the predictive factors that are associated with successful taper of TNF-α
      inhibitors. Also, investigate the effects associated with dose tapering of TNF-α inhibitors.
observational model: Cohort
time perspective: Retrospective
measure: time to disease relapse
time frame: hrough study completion, an average of 10 year
description: me to relapse after tapering or discontinuing TNF-α inhibitors
arm group label: Tapering
description: TNF-α inhibitors
arm group label: Discontinuing
description: TNF-α inhibitors
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 20 Years
maximum age: 90 Years
healthy volunteers: No
last name: Yen-Hui Chen
role: Principal Investigator
affiliation: NTU Clinical Pharmacy School
last name: Yen-Hui Chen
phone: 33668790
email: tcyhchen@ntu.edu.tw
facility: 
status: Recruiting
contact: 
country: Taiwan
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid