<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/NCT01717846</url>
  </required_header>
  <id_info>
    <org_study_id>IM101-356</org_study_id>
    <secondary_id>IM101-356</secondary_id>
    <nct_id>NCT01717846</nct_id>
  </id_info>
  <brief_title>Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and APC Cells in Rheumatoid Arthritis</brief_title>
  <acronym>RA</acronym>
  <official_title>In Vivo Effect on Orencia (Abatacept) on the Apoptosis of T Cells, B Cells and Antigen Presenting (APC) Cells in Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Bristol-Myers Squibb</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>University of California, Los Angeles</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related&#xD;
      genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Orencia may regulate apoptosis and apoptosis related genes in vivo in rheumatoid arthritis&#xD;
      (RA) patient's cells. To date, no studies have been performed to evaluate the effect of&#xD;
      Orencia on apoptosis in RA patients.&#xD;
&#xD;
      Primary: To determine the effect of Abatacept in the apoptosis of T cells, B cells and&#xD;
      antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.&#xD;
&#xD;
      Secondary: To evaluate the association between the changes in apoptosis to changes in disease&#xD;
      activity measures (DAS28/ESR) over 6 months of treatment with subcutaneous injection of&#xD;
      abatacept.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Withdrawn</overall_status>
  <why_stopped>
    The PI has left UCLA and we do not plan to pursue this study.&#xD;
  </why_stopped>
  <start_date>December 2012</start_date>
  <completion_date type="Anticipated">November 2014</completion_date>
  <primary_completion_date type="Anticipated">November 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To measure the change in apoptosis of T cells, B cells and antigen presenting (APC) cells in Rheumatoid Arthritis between the baseline, 3 months and at 6 months time points</measure>
    <time_frame>Base line, 3 and 6 months</time_frame>
    <description>To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>To measure the changes in disease activity score joint count (DAS28/ESR)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>To measure the change in clinical disease activity index between base line, at 3 months and 6 months time points.</measure>
    <time_frame>Baseline, 3 and 6 months</time_frame>
    <description>To measure the Clinical Disease Activity Index (CDAI), and Health Assessment Questionnaire (HAQ)</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">0</enrollment>
  <condition>Apoptotic DNA Damage</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>T-cell Lymphocytosis</condition>
  <arm_group>
    <arm_group_label>Arm 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Orencia Group is for RA patients who have not received any other biologic treatment, including abatacept previously, and whose doctor has determined that it is appropriate to treat their RA with Abatacept. If you are in Group 1, you will receive the study drug, Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form. Abatacept, given in an intravenous injection is approved by the FDA for the treatment of RA.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm 2 or group 2</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Group 1 or Orencia treated group</intervention_name>
    <description>Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.</description>
    <arm_group_label>Arm 1</arm_group_label>
    <other_name>Abatacept</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Group 2 (DMARDS treated group)</intervention_name>
    <description>Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept.</description>
    <arm_group_label>Arm 2 or group 2</arm_group_label>
    <other_name>Arm 2 or group 2</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Over age 18&#xD;
&#xD;
          2. Meeting ACR Criteria 1987 for RA diagnosis&#xD;
&#xD;
          3. Naïve to treatment with abatacept&#xD;
&#xD;
          4. Must be able to understand information in the Informed Consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pregnancy or breast feeding&#xD;
&#xD;
          2. Previous exposure to abatacept.&#xD;
&#xD;
          3. History of a concomitant autoimmune disease (eg. SLE, PsA etc.)&#xD;
&#xD;
          4. Patients with history of cancer&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>85 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ram P Singh, MS, Ph.D.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of California at Los Angeles, UCLA</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mihaela Taylor, MD</last_name>
    <role>Study Director</role>
    <affiliation>University of California at Los Angeles (UCLA)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Univerity of California at Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>May 2016</verification_date>
  <study_first_submitted>October 24, 2012</study_first_submitted>
  <study_first_submitted_qc>October 30, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 31, 2012</study_first_posted>
  <last_update_submitted>May 9, 2016</last_update_submitted>
  <last_update_submitted_qc>May 9, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">May 11, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Apoptosos</keyword>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>T cells, B cells</keyword>
  <keyword>DAS28</keyword>
  <keyword>Clinical Disease activity Index</keyword>
  <keyword>CDAI</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>
    <mesh_term>Lymphocytosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Abatacept</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/NCT01717846
org study id: IM101-356
secondary id: IM101-356
nct id: NCT01717846
lead sponsor: 
collaborator: 
has dmc: No
This proposal will test the hypothesis that Orencia affects apoptosis and apoptosis related
      genes/biomarkers in vivo in rheumatoid arthritis (RA) patients.
Orencia may regulate apoptosis and apoptosis related genes in vivo in rheumatoid arthritis
      (RA) patient's cells. To date, no studies have been performed to evaluate the effect of
      Orencia on apoptosis in RA patients.

      Primary: To determine the effect of Abatacept in the apoptosis of T cells, B cells and
      antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.

      Secondary: To evaluate the association between the changes in apoptosis to changes in disease
      activity measures (DAS28/ESR) over 6 months of treatment with subcutaneous injection of
      abatacept.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To measure the change in apoptosis of T cells, B cells and antigen presenting (APC) cells in Rheumatoid Arthritis between the baseline, 3 months and at 6 months time points
time frame: Base line, 3 and 6 months
description: To determine the effect of Abatacept in the apoptosis of T cells, B cells and antigen presenting cells (APC) in RA patients at baseline, 3 months and 6 months.
measure: To measure the change in disease activity score (DAS28) between the baseline, 3 months and 6 months time points
time frame: Baseline, 3 and 6 months
description: To measure the changes in disease activity score joint count (DAS28/ESR)
measure: To measure the change in clinical disease activity index between base line, at 3 months and 6 months time points.
time frame: Baseline, 3 and 6 months
description: To measure the Clinical Disease Activity Index (CDAI), and Health Assessment Questionnaire (HAQ)
arm group label: Arm 1
arm group type: Experimental
description: Orencia Group is for RA patients who have not received any other biologic treatment, including abatacept previously, and whose doctor has determined that it is appropriate to treat their RA with Abatacept. If you are in Group 1, you will receive the study drug, Abatacept, given in an intravenous (IV - injected into a vein) as well as subcutaneous form. Abatacept, given in an intravenous injection is approved by the FDA for the treatment of RA.
arm group label: Arm 2 or group 2
arm group type: Other
description: Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept.
intervention type: Drug
intervention name: Group 1 or Orencia treated group
description: Group 1 subjects will be given subcutaneous abatacept, 125 mg once a week upto 6 months.
arm group label: Arm 1
other name: Abatacept
intervention type: Other
intervention name: Group 2 (DMARDS treated group)
description: Arm 2 or Group 2 is for RA patients who are being treated wth non-biologic DMARDS who, with their doctor, have decided that they will not be receiving treatment with Abatacept in the next six months. These patients will not receive the study drug abatacept.
arm group label: Arm 2 or group 2
other name: Arm 2 or group 2
criteria: 
gender: All
minimum age: 18 Years
maximum age: 85 Years
healthy volunteers: No
last name: Ram P Singh, MS, Ph.D.
role: Principal Investigator
affiliation: University of California at Los Angeles, UCLA
last name: Mihaela Taylor, MD
role: Study Director
affiliation: University of California at Los Angeles (UCLA)
facility: 
country: United States
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
mesh term: Lymphocytosis
mesh term: Abatacept