<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/NCT04454034</url>
  </required_header>
  <id_info>
    <org_study_id>M2019072</org_study_id>
    <nct_id>NCT04454034</nct_id>
  </id_info>
  <brief_title>Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis</brief_title>
  <official_title>Arthroscopic Synovectomy Combined With DMARDs in the Treatment of Refractory Elbow Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Peking University Third Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Peking University Third Hospital</source>
  <brief_summary>
    <textblock>
      Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic and aggressive&#xD;
      polyarthritis. The prevalence of RA in China is about 0.42%. Arthroscopic synovectomy (AS) is&#xD;
      an important method to save the function of joint in the treatment of refractory RA. The&#xD;
      clinical trial is to study the value of AS combine with DMARDs in the early stage of&#xD;
      refractory RA.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">August 1, 2019</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">July 31, 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>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>ACR70 remission</measure>
    <time_frame>6 months after surgery</time_frame>
    <description>the percent of patients who meet ACR70 remission</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)</measure>
    <time_frame>1,3,6 and 12 months after surgery</time_frame>
    <description>Remission: 2.6 Low activity: 2.6 to ,3.2 Moderate activity: 3.2 to 5.1 High activity: .5.1</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>tender joint count</measure>
    <time_frame>1,3,6 and 12 months after surgery</time_frame>
    <description>the number of tender joints</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>swollen joint count</measure>
    <time_frame>1,3,6 and 12 months after surgery</time_frame>
    <description>the number of swollen joints</description>
  </secondary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">25</enrollment>
  <condition>Rheumatoid Arthritis of Ankle</condition>
  <arm_group>
    <arm_group_label>Group1</arm_group_label>
    <description>The refractory elbow RA who undergo arthroscopic synovectomy</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>arthroscopic synovectomy</intervention_name>
    <description>arthroscopic synovectomy</description>
    <arm_group_label>Group1</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        the patients who fullfill the Eligibility Criteria&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  The patients who fulfilled the 1987 ACR（American College of Rheumatology) or 2010&#xD;
             ACR/EULAR（European League Against Rheumatism） RA classification criteria.&#xD;
&#xD;
          -  The age is more than 18 years old and less than 60 years old.&#xD;
&#xD;
          -  They received stable traditional DMARDs (including Chrysopidae, leflunomide,&#xD;
             sulfasalazine, hydroxychloroquine, eilamod) or biological dmrads (including tumor&#xD;
             necrosis factor antagonists, IL(Interleukin)-6 receptor antagonists, CD20 monoclonal&#xD;
             antibodies) for at least 6 months.&#xD;
&#xD;
          -  The disease is still in the active stage, which means the disease activity score&#xD;
             (DAS28) is more than 3.2, and the elbow joint function is obviously limited.&#xD;
&#xD;
          -  The patient agreed to undergo arthroscopic synovectomy.&#xD;
&#xD;
          -  No contraindications were found.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  The disease is in remission.&#xD;
&#xD;
          -  The patient has contraindications.&#xD;
&#xD;
          -  Arthroscopic synovectomy was performed in different patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Peking Univerisity Third Hospital</name>
      <address>
        <city>Beijing</city>
        <state>Beijing</state>
        <zip>100191</zip>
        <country>China</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 27, 2020</study_first_submitted>
  <study_first_submitted_qc>June 27, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 1, 2020</study_first_posted>
  <last_update_submitted>June 25, 2021</last_update_submitted>
  <last_update_submitted_qc>June 25, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 28, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Rheumatoid Arthritis</keyword>
  <keyword>Arthroscopic Synovectomy</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>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT04454034
org study id: M2019072
nct id: NCT04454034
lead sponsor: 
Rheumatoid arthritis (RA) is an autoimmune disease characterized by chronic and aggressive
      polyarthritis. The prevalence of RA in China is about 0.42%. Arthroscopic synovectomy (AS) is
      an important method to save the function of joint in the treatment of refractory RA. The
      clinical trial is to study the value of AS combine with DMARDs in the early stage of
      refractory RA.
observational model: Cohort
time perspective: Prospective
measure: ACR70 remission
time frame: 6 months after surgery
description: the percent of patients who meet ACR70 remission
measure: Disease Activity Score (DAS) 28-erythrocyte sedimentation rate (ESR) (range 0-9.4)
time frame: 1,3,6 and 12 months after surgery
description: Remission: 2.6 Low activity: 2.6 to ,3.2 Moderate activity: 3.2 to 5.1 High activity: .5.1
measure: tender joint count
time frame: 1,3,6 and 12 months after surgery
description: the number of tender joints
measure: swollen joint count
time frame: 1,3,6 and 12 months after surgery
description: the number of swollen joints
arm group label: Group1
description: The refractory elbow RA who undergo arthroscopic synovectomy
intervention type: Procedure
intervention name: arthroscopic synovectomy
description: arthroscopic synovectomy
arm group label: Group1
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
facility: 
country: China
responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: Undecided