<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/NCT01685918</url>
  </required_header>
  <id_info>
    <org_study_id>ederly_RA</org_study_id>
    <nct_id>NCT01685918</nct_id>
  </id_info>
  <brief_title>Safety and Effectiveness of Biological DMARDs in Elderly Patients With Rheumatoid Arthritis</brief_title>
  <official_title>Safety and Effectiveness of Biological DMARDs in Elderly Patients With Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hanyang University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>Hanyang University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study objectives&#xD;
&#xD;
        1. Comparison of drug persistency rates between elderly RA patients and young RA patients&#xD;
           with biological DMARDs&#xD;
&#xD;
        2. Analysis of discontinuation reasons &amp; influencing factors of drug discontinuation in&#xD;
           elderly RA patients and young RA patients&#xD;
&#xD;
        3. Comparison of the occurrence of adverse events &amp; treatment outcomes between elderly RA&#xD;
           patients and young RA patients&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      1. Retrospective study:&#xD;
&#xD;
           We will collect data of Korean patients with RA retrospectively. Subjects will be&#xD;
           extracted from medical records of RA patients who had treated with TNF inhibitor or are&#xD;
           currently using TNF inhibitor. Patients who have received or are receiving biologic&#xD;
           agents including infliximab, etanercept, adalimumab, rituximab from Dec.2000 to Dec.2010&#xD;
           will be enrolled.&#xD;
&#xD;
           Data for this study which are sex, date of birth, previous and current medication, the&#xD;
           results of laboratory test, disease activity of RA (DAS28ESR), comorbidity will be&#xD;
           collected. Information of treatment, DAS28ESR, laboratory data and SAEs will be&#xD;
           collected at baseline and predefined time points of follow-up (0, 3 month and recent&#xD;
           follow-up data).&#xD;
&#xD;
           During the first year of starting our study, we will focus to evaluate tolerability, the&#xD;
           reason of discontinuation in elderly RA patients through this retrospective study.&#xD;
           Tolerance could be analyzed by examining drug persistency of biologic DMARDs with the&#xD;
           reason that led to drug interruption, and the drug persistency curves will be compared&#xD;
           in the two groups. The length of time that patients remain on the drug therapy&#xD;
           represents a useful measure of the treatment effectiveness and tolerability. The reason&#xD;
           of discontinuation will be evaluate as descriptive analysis. And factors influenced on&#xD;
           drug discontinuation in elderly RA patients and young RA patients using Cox-proportional&#xD;
           analysis.&#xD;
&#xD;
        2. Prospectively study:&#xD;
&#xD;
      We will use the data of patients of Hanyang University Hospital for Rheumatic Diseases in&#xD;
      web-based registry of RA patients with biologic DMARDs. Patients who start on receiving&#xD;
      biologic agents including infliximab, etanercept, adalimumab, rituximab, abatacept will be&#xD;
      enrolled. At registration, sex, date of birth, previous and current medication, the results&#xD;
      of laboratory test, disease activity of RA (DAS28ESR), HAQ, comorbidity, socioeconomic&#xD;
      status, etc. will be collected. Information of treatment, DAS28ESR, HAQ, laboratory data and&#xD;
      SAEs, etc. will be collected at baseline and predefined time points of follow-up (0, 3 month&#xD;
      and every 6 month). This prospective study will be progressed during three years.&#xD;
&#xD;
      We will focus the response of biologic DMARDs and the occurrence of adverse event in elderly&#xD;
      RA patients in this prospective study. The response could be evaluated with the change of&#xD;
      DAS28ESR and functional disability (HAQ). We will compare the response in elderly RA patients&#xD;
      versus young RA patients, and evaluate the impact of old age on the response using multiple&#xD;
      logistic regression model with adjust various confounding factors. The occurrence of adverse&#xD;
      events during three years will be described in two groups&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>April 2012</start_date>
  <completion_date type="Anticipated">August 2016</completion_date>
  <primary_completion_date type="Anticipated">August 2013</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>drug(biologics) persistency rates</measure>
    <time_frame>Patients who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab from Dec.2000 to Dec.2010 will be enrolled.</time_frame>
    <description>The tolerability in the two groups (elderly RA patients and young RA patients) will be estimated by drug persistency rates using the Kaplan-Meier method. Comparisons between the resultant curves will be made by log rank test.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Treatement response (HAQ, DAS28)</measure>
    <time_frame>Information of treatment, DAS28ESR, HAQ, laboratory data and SAEs, etc. will be collected at baseline and predefined time points of follow-up (0, 3 month and every 6 month). This prospective study will be progressed during three years.</time_frame>
    <description>Treatments outcomes will be compared between two groups (elderly RA patients and young RA patients). The significance of differences in mean values of continuous variables will be assessed with Student's t-test. We will evaluate the impact of old age on the response using Cox proportional hazard analysis with adjust various confounding factors.</description>
  </secondary_outcome>
  <enrollment type="Anticipated">600</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <eligibility>
    <study_pop>
      <textblock>
        1. Retrospective study: 425 patients with RA We will collect data of Korean patients with&#xD;
             RA retrospectively. Subjects will be extracted from medical records of RA patients who&#xD;
             had treated with biological DMARDs or are currently using biological DMARDs from Dec&#xD;
             2000 to Dec 2010.&#xD;
&#xD;
          2. Prospectively study: 203 patients with RA We will use the web-based registry of RA&#xD;
             patients with biologic DMARDs. This prospective study will be progressed during three&#xD;
             years.&#xD;
&#xD;
        We will compare the response in elderly RA patients versus young RA patients, and evaluate&#xD;
        the impact of old age on the response. The occurrence of adverse events during three years&#xD;
        will be described.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Retrospective study&#xD;
&#xD;
               -  Patients who satisfy the 1987 ACR classification criteria for RA&#xD;
&#xD;
               -  Patients with RA who have received or are receiving biologic agents including&#xD;
                  infliximab, etanercept, adalimumab, rituximab.&#xD;
&#xD;
          2. Prospective study&#xD;
&#xD;
               -  Patients who satisfy the 1987 ACR classification criteria for RA&#xD;
&#xD;
               -  Patients with RA who have received or are receiving biologic agents including&#xD;
                  infliximab, etanercept, adalimumab, rituximab, abatacept.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients younger than eighteen&#xD;
&#xD;
          2. Patients enrolled in clinical trials&#xD;
&#xD;
          3. For the prospective study: Sex and Reproductive Status&#xD;
&#xD;
               1. WOCBP who are unwilling or unable to use an acceptable method to avoid pregnancy&#xD;
                  for the entire study period and for up to 10 weeks after the last dose of study&#xD;
                  drug.&#xD;
&#xD;
               2. Women who are pregnant or breastfeeding.&#xD;
&#xD;
               3. Women with a positive pregnancy test on enrollment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Sang-cheol Bae, Director</last_name>
    <role>Principal Investigator</role>
    <affiliation>Hanyang University Hospital for Rheumatic Disease</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Sang-cheol Bae, Director</last_name>
    <phone>82-2-2290-8260</phone>
    <email>scbae@hanyang.ac.kr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hanyang University Hospital for rheumatic disease</name>
      <address>
        <city>Seoul</city>
        <state>Sung-dong Gu</state>
        <zip>133-792</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Sang-cheol Bae, MD</last_name>
      <phone>82-2-2290-9230</phone>
      <email>scbae@hanyang.ac.kr</email>
    </contact>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>September 2012</verification_date>
  <study_first_submitted>September 12, 2012</study_first_submitted>
  <study_first_submitted_qc>September 12, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 14, 2012</study_first_posted>
  <last_update_submitted>September 12, 2012</last_update_submitted>
  <last_update_submitted_qc>September 12, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 14, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hanyang University</investigator_affiliation>
    <investigator_full_name>Sang-Cheol Bae</investigator_full_name>
    <investigator_title>Professor, MD, PhD, MPH</investigator_title>
  </responsible_party>
  <keyword>Rheumatoid arthritis</keyword>
  <keyword>aged</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/NCT01685918
org study id: ederly_RA
nct id: NCT01685918
lead sponsor: 
collaborator: 
has dmc: No
Study objectives

        1. Comparison of drug persistency rates between elderly RA patients and young RA patients
           with biological DMARDs

        2. Analysis of discontinuation reasons & influencing factors of drug discontinuation in
           elderly RA patients and young RA patients

        3. Comparison of the occurrence of adverse events & treatment outcomes between elderly RA
           patients and young RA patients
1. Retrospective study:

           We will collect data of Korean patients with RA retrospectively. Subjects will be
           extracted from medical records of RA patients who had treated with TNF inhibitor or are
           currently using TNF inhibitor. Patients who have received or are receiving biologic
           agents including infliximab, etanercept, adalimumab, rituximab from Dec.2000 to Dec.2010
           will be enrolled.

           Data for this study which are sex, date of birth, previous and current medication, the
           results of laboratory test, disease activity of RA (DAS28ESR), comorbidity will be
           collected. Information of treatment, DAS28ESR, laboratory data and SAEs will be
           collected at baseline and predefined time points of follow-up (0, 3 month and recent
           follow-up data).

           During the first year of starting our study, we will focus to evaluate tolerability, the
           reason of discontinuation in elderly RA patients through this retrospective study.
           Tolerance could be analyzed by examining drug persistency of biologic DMARDs with the
           reason that led to drug interruption, and the drug persistency curves will be compared
           in the two groups. The length of time that patients remain on the drug therapy
           represents a useful measure of the treatment effectiveness and tolerability. The reason
           of discontinuation will be evaluate as descriptive analysis. And factors influenced on
           drug discontinuation in elderly RA patients and young RA patients using Cox-proportional
           analysis.

        2. Prospectively study:

      We will use the data of patients of Hanyang University Hospital for Rheumatic Diseases in
      web-based registry of RA patients with biologic DMARDs. Patients who start on receiving
      biologic agents including infliximab, etanercept, adalimumab, rituximab, abatacept will be
      enrolled. At registration, sex, date of birth, previous and current medication, the results
      of laboratory test, disease activity of RA (DAS28ESR), HAQ, comorbidity, socioeconomic
      status, etc. will be collected. Information of treatment, DAS28ESR, HAQ, laboratory data and
      SAEs, etc. will be collected at baseline and predefined time points of follow-up (0, 3 month
      and every 6 month). This prospective study will be progressed during three years.

      We will focus the response of biologic DMARDs and the occurrence of adverse event in elderly
      RA patients in this prospective study. The response could be evaluated with the change of
      DAS28ESR and functional disability (HAQ). We will compare the response in elderly RA patients
      versus young RA patients, and evaluate the impact of old age on the response using multiple
      logistic regression model with adjust various confounding factors. The occurrence of adverse
      events during three years will be described in two groups
observational model: Cohort
time perspective: Prospective
measure: drug(biologics) persistency rates
time frame: Patients who have received or are receiving biologic agents including infliximab, etanercept, adalimumab, rituximab from Dec.2000 to Dec.2010 will be enrolled.
description: The tolerability in the two groups (elderly RA patients and young RA patients) will be estimated by drug persistency rates using the Kaplan-Meier method. Comparisons between the resultant curves will be made by log rank test.
measure: Treatement response (HAQ, DAS28)
time frame: Information of treatment, DAS28ESR, HAQ, laboratory data and SAEs, etc. will be collected at baseline and predefined time points of follow-up (0, 3 month and every 6 month). This prospective study will be progressed during three years.
description: Treatments outcomes will be compared between two groups (elderly RA patients and young RA patients). The significance of differences in mean values of continuous variables will be assessed with Student's t-test. We will evaluate the impact of old age on the response using Cox proportional hazard analysis with adjust various confounding factors.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Sang-cheol Bae, Director
role: Principal Investigator
affiliation: Hanyang University Hospital for Rheumatic Disease
last name: Sang-cheol Bae, Director
phone: 82-2-2290-8260
email: scbae@hanyang.ac.kr
facility: 
status: Recruiting
contact: 
country: Korea, Republic of
responsible party type: Principal Investigator
investigator affiliation: Hanyang University
investigator full name: Sang-Cheol Bae
investigator title: Professor, MD, PhD, MPH
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid