<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/NCT03266822</url>
  </required_header>
  <id_info>
    <org_study_id>ETT-TUKEB905/PI/09</org_study_id>
    <nct_id>NCT03266822</nct_id>
  </id_info>
  <brief_title>T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy</brief_title>
  <official_title>T-cell Subsets in Rheumatoid Arthritis Patients on Long-term Anti-TNF or IL6-receptor-blocker Therapy</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szeged University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Szeged University</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>
      Data on the impact of biological therapies, especially of IL6-blocker treatment, on the&#xD;
      T-cell phenotype in rheumatoid arthritis (RA) are limited, inconclusive, and mainly involve&#xD;
      short-term follow-up.&#xD;
&#xD;
      Here, the investigator prospectively measure the percentages of 15 circulating T-cell&#xD;
      subtypes using flow cytometry. The investigators aim to obtained transversal and longitudinal&#xD;
      data in 30 anti-TNF responders, 19 secondary anti-TNF-non-responders, 43&#xD;
      IL6R-antagonist-responders before, 8 weeks and, after, at least, 6 months of biological&#xD;
      therapy. These are then compared with results obtained in early, untreated RA patients and&#xD;
      gender-and-age matched healthy controls.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 2, 2013</start_date>
  <completion_date type="Actual">May 31, 2016</completion_date>
  <primary_completion_date type="Actual">December 30, 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Flow cytometry for the assessment of change in T cell subtypes</measure>
    <time_frame>Before, after 8 weeks and after at least 6 months of the initiation of biological therapy.</time_frame>
    <description>The percentages of 15 circulating T-cell subtypes were measured using flow cytometry.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">122</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>Healthy control</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>RA patients on anti-TNF therapy</arm_group_label>
  </arm_group>
  <arm_group>
    <arm_group_label>RA patients on anti-IL-6R therapy</arm_group_label>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>No intervention</intervention_name>
    <description>Observational study</description>
    <arm_group_label>Healthy control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        In the cross-sectional analysis, 92 RA patients (who had been treated with biological&#xD;
        therapy for more than six months) were evaluated.&#xD;
&#xD;
        As a further control group (healthy controls), we enrolled 30 age- and gender-matched&#xD;
        healthy volunteers.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria for patients:&#xD;
&#xD;
          -  Diagnosis of rheumatoid arthritis classified according to the 2010 ACR/EULAR&#xD;
             classification criteria for RA&#xD;
&#xD;
          -  Biological treatment with anti-TNF therapy (adalimumab or certolizumab pegol or&#xD;
             etanercept or infliximab or golimumab) or anti-IL-6R agent (tocilizumab)&#xD;
&#xD;
        Inclusion Criteria for healthy controls:&#xD;
&#xD;
          -  negative history of RA symptoms&#xD;
&#xD;
          -  negative status upon detailed physical and laboratory examination including normal CRP&#xD;
             and ESR values&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  other autoimmune comorbidity&#xD;
&#xD;
          -  lack of informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>August 24, 2017</study_first_submitted>
  <study_first_submitted_qc>August 29, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 30, 2017</study_first_posted>
  <last_update_submitted>August 29, 2017</last_update_submitted>
  <last_update_submitted_qc>August 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 30, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </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>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Upon request</ipd_description>
  </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/NCT03266822
org study id: ETT-TUKEB905/PI/09
nct id: NCT03266822
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Data on the impact of biological therapies, especially of IL6-blocker treatment, on the
      T-cell phenotype in rheumatoid arthritis (RA) are limited, inconclusive, and mainly involve
      short-term follow-up.

      Here, the investigator prospectively measure the percentages of 15 circulating T-cell
      subtypes using flow cytometry. The investigators aim to obtained transversal and longitudinal
      data in 30 anti-TNF responders, 19 secondary anti-TNF-non-responders, 43
      IL6R-antagonist-responders before, 8 weeks and, after, at least, 6 months of biological
      therapy. These are then compared with results obtained in early, untreated RA patients and
      gender-and-age matched healthy controls.
observational model: Case-Control
time perspective: Prospective
measure: Flow cytometry for the assessment of change in T cell subtypes
time frame: Before, after 8 weeks and after at least 6 months of the initiation of biological therapy.
description: The percentages of 15 circulating T-cell subtypes were measured using flow cytometry.
arm group label: Healthy control
arm group label: RA patients on anti-TNF therapy
arm group label: RA patients on anti-IL-6R therapy
intervention type: Other
intervention name: No intervention
description: Observational study
arm group label: Healthy control
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: Undecided
ipd description: Upon request