<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/NCT04505982</url>
  </required_header>
  <id_info>
    <org_study_id>CHUB-IL6</org_study_id>
    <nct_id>NCT04505982</nct_id>
  </id_info>
  <brief_title>Anti IL6R Reduce Complement Serum Level in Rheumatoid Arthritis Patients: Facts and Implications</brief_title>
  <official_title>Anti IL6R Reduce Complement Serum Level in Rheumatoid Arthritis Patients: Facts and Implications: Monocentric Study in Belgian Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BADOT, Valerie</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Brugmann 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>
      Interleukin 6 is identified as a cytokine with pro and anti-inflammatory effects, depending&#xD;
      on the context to which it is exposed, exerting a role in the expansion and activation of T&#xD;
      lymphocytes, in the survival, expansion and the maturation of B lymphocytes and plasmablasts&#xD;
      as well as in the regulation of the acute phase response. The IL-6 receptor complex is a&#xD;
      dimer in which each monomer is composed of an 80 kD subunit, IL-6R or CD126, expressed in&#xD;
      hepatocytes, leukocytes and in megakaryocytes, which binds IL- 6 and a 130 kD subunit, gp130&#xD;
      or CD130, which is expressed ubiquitously. Its effects are mediated mainly by the way of&#xD;
      tyrosine kinases of the Jaks family, and transcription factors of the STATs family.&#xD;
&#xD;
      The complement system is made up of a set of plasma proteins, cascading through three&#xD;
      activation pathways (classical, alternate and lectin pathway). This system is considered part&#xD;
      of innate immunity. It is also part of the acute phase response.The complement has several&#xD;
      functions: cell lysis by formation of the membrane attack complex; opsonization and&#xD;
      activation of phagocytosis of foreign particles, elimination of circulating immune complexes,&#xD;
      and regulation of the adaptive immunity response and inflammation via anaphylatoxins.&#xD;
&#xD;
      After reviewing the literature, the link between IL6 and the complement system can be&#xD;
      summarized as an induction of factor C3 and factor B, but also probably CD55 (DAF or Decay&#xD;
      acceleration factor) and CD59 (MAC-IP or MAC-Inhibitory Protein) by interleukin-6. The&#xD;
      effects of IL-6 on the lectin pathway, on the other hand, seem contradictory: inhibition or&#xD;
      induction of the synthesis of MASP1 / 3 and 2 depending on the experimental model.&#xD;
&#xD;
      It has become common knowledge that anti-IL6 receptor monoclonal antibodies, used in the&#xD;
      treatment of patients with rheumatoid arthritis and other inflammatory conditions, reduce the&#xD;
      serum levels of acute phase proteins and in particular the levels of CRP. But what about&#xD;
      other acute phase proteins and in particular the complement ?&#xD;
&#xD;
      A recent study showed that the serum levels of the complement components C3 and C4 were also&#xD;
      reduced after the use of tocilizumab and this as early as 4 weeks after the first&#xD;
      administration. To the investigator's knowledge, this is the only study reporting a decrease&#xD;
      in complement during treatment with anti-IL6R.&#xD;
&#xD;
      This study would allow the evaluation of complement parameters in the population of patients&#xD;
      under treatment with antiIL6R (tocilizumab or sarilumab) within the CHU Brugmann Hospital in&#xD;
      order to&#xD;
&#xD;
        -  confirm or not this observation&#xD;
&#xD;
        -  look for a possible secondary clinical consequence&#xD;
&#xD;
        -  compare this decrease with the activity of the disease in order to see if it could be a&#xD;
           marker of effectiveness&#xD;
&#xD;
        -  put this decrease in parallel with the side effects / tolerance of the treatment in&#xD;
           order to see if it could be a marker of toxicity / safety&#xD;
&#xD;
      This study will also investigate the subpopulations of B lymphocytes (memory B, transitional&#xD;
      B, and plasmablasts) in order to assess whether the evolution of one of these lines would be&#xD;
      predictive of a therapeutic response.&#xD;
&#xD;
      Secondly, this study would eventually allow&#xD;
&#xD;
        -  to improve the understanding of the mechanisms of action of the treatment on&#xD;
           inflammatory markers by evaluating the activity of the residual complement&#xD;
&#xD;
        -  to raise the need to find new parameters for monitoring inflammatory activity in these&#xD;
           patients, since CRP assays are not very helpful.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 14, 2020</start_date>
  <completion_date type="Anticipated">December 2020</completion_date>
  <primary_completion_date type="Anticipated">December 2020</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>Demographic data</measure>
    <time_frame>5 minutes</time_frame>
    <description>Age, sex</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Body Mass Index</measure>
    <time_frame>5 minutes</time_frame>
    <description>Body Mass Index</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Medical History (descriptive listing)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Medical History (descriptive listing)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Neoplasia</measure>
    <time_frame>5 minutes</time_frame>
    <description>Active neoplasia, or neoplasia dated less than 5 years</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Activity Score Calculator for Rheumatoid Arthritis- DAS28VS</measure>
    <time_frame>5 minutes</time_frame>
    <description>The DAS28 is a measure of disease activity in rheumatoid arthritis . DAS stands for 'disease activity score' and the number 28 refers to the 28 joints that are examined in this assessment. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Disease Activity Score Calculator for Rheumatoid Arthritis- DAS28CRP</measure>
    <time_frame>5 minutes</time_frame>
    <description>The DAS28 is a measure of disease activity in rheumatoid arthritis . DAS stands for 'disease activity score' and the number 28 refers to the 28 joints that are examined in this assessment. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Health Assessment Questionnaire (HAQ)</measure>
    <time_frame>5 minutes</time_frame>
    <description>The Health Assessment Questionnaire Disability Index (HAQ) is developed for the assessment of disability in patients with Rheumatoid Arthritis. It focuses on two dimensions of health status, physical disability (eight categories), and pain. The eight categories review a total of 20 specific functions and evaluate patient's difficulty with activities of daily living over the past week.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Concomitant medication (descriptive listing)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Concomitant medication (descriptive listing)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Adverse events linked to the medication (descriptive listing)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Adverse events linked to the medication (descriptive listing)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hemogram: normal (yes/no)</measure>
    <time_frame>5 minutes</time_frame>
    <description>A hemogram contains all of the pertinent information required for assessment of hematopoiesis as well as a visual assessment of plasma appearance and measurement of total solids (an estimate of total protein) in plasma.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Leukocyte count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Leukocyte count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Blood Ionogram: normal (yes/no)</measure>
    <time_frame>5 minutes</time_frame>
    <description>The blood ionogram analyses the ionic composition of the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Renal function: normal (yes/no)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Renal function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hepatic function: normal (yes/no)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Hepatic function</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Parathyroid hormone count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Parathyroid hormone count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Vitamin D count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Vitamin D count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lipid balance: normal (yes/no)</measure>
    <time_frame>5 minutes</time_frame>
    <description>Lipid balance allows monitoring of cholesterol (LDL-cholesterol and HDL-cholesterol) and triglycerides</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Glucose concentration in the blood</measure>
    <time_frame>5 minutes</time_frame>
    <description>Glucose concentration in the blood</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Rheumatoid factor concentration</measure>
    <time_frame>5 minutes</time_frame>
    <description>Rheumatoid factor is an autoantibody that induces inflammation and damage to the joints.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>AntiCCP antibodies count</measure>
    <time_frame>5 minutes</time_frame>
    <description>The detection of anti-CCP antibodies is used to help diagnose and prognosticate rheumatoid arthritis and differentiate it from other types of arthritis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>FAN count</measure>
    <time_frame>5 minutes</time_frame>
    <description>FAN are autoantibodies against elements of the nucleus</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Sedimentation rate</measure>
    <time_frame>5 minutes</time_frame>
    <description>Sedimentation rate</description>
  </primary_outcome>
  <primary_outcome>
    <measure>CRP count</measure>
    <time_frame>5 minutes</time_frame>
    <description>CRP count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complement fraction C1q count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Complement fraction C1q count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complement fraction C3 count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Complement fraction C3 count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complement fraction C3d count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Complement fraction C3d count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complement fraction C3a count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Complement fraction C3a count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complement fraction C4 count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Complement fraction C4 count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complement fraction C4a count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Complement fraction C4a count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complement fraction CH50 count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Complement fraction CH50 count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complement fraction FB count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Complement fraction FB count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lectin count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Lectin count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lectin complement pathway serine protease 2 (MASP-2) count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Lectin complement pathway serine protease 2 (MASP-2) count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Mannose Binding lectin (MBL) count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Mannose Binding lectin (MBL) count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Complement SC5b9 count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Complement SC5b9 count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Fibrinogen count</measure>
    <time_frame>5 minutes</time_frame>
    <description>Fibrinogen count</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymphocyte B count: memory cells</measure>
    <time_frame>5 minutes</time_frame>
    <description>Lymphocyte B count: memory cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymphocyte B count: transitional cells</measure>
    <time_frame>5 minutes</time_frame>
    <description>Lymphocyte B count: transitional cells</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Lymphocyte B count: plasmablast cells</measure>
    <time_frame>5 minutes</time_frame>
    <description>Lymphocyte B count: plasmablast cells</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Rheumatoid Polyarthritis</condition>
  <arm_group>
    <arm_group_label>Tocilizumab intravenous</arm_group_label>
    <description>Patients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with tocilizumab, intravenous</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tocilizumab subcutaneous</arm_group_label>
    <description>Patients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with tocilizumab, subcutaneous</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Sarilumab subcutaneous</arm_group_label>
    <description>Patients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with sarilumab, subcutaneous</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Data extraction from medical files</intervention_name>
    <description>Data extraction from medical files</description>
    <arm_group_label>Sarilumab subcutaneous</arm_group_label>
    <arm_group_label>Tocilizumab intravenous</arm_group_label>
    <arm_group_label>Tocilizumab subcutaneous</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Patients followed in the CHU Brugmann Hospital for a rhumatoid polyarthiritis and treated&#xD;
        according to standard of care with tocilizumab / sarilumab or for which this treatment is&#xD;
        about to be initiated, in intravenous or subcutaneous form&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient ≥ 18 years old&#xD;
&#xD;
          -  Regular follow-up at CHU Brugmann Hospital for confirmed rheumatoid arthritis and&#xD;
             meeting the ACR 2010 criteria&#xD;
&#xD;
          -  On tocilizumab / sarilumab or for which this treatment is about to be initiated, in&#xD;
             intravenous or subcutaneous form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with a known complement deficiency before their rheumatic pathology&#xD;
&#xD;
          -  Patient with hepatic impairment&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
  </eligibility>
  <overall_official>
    <last_name>Tracy Vandergraesen, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>CHU Brugmann</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Tracy Vandergraesen, MD</last_name>
    <phone>003224754508</phone>
    <email>Tracy.VANDERGRAESEN@chu-brugmann.be</email>
  </overall_contact>
  <location>
    <facility>
      <name>Brugmann University Hospital</name>
      <address>
        <city>Brussels</city>
        <zip>1020</zip>
        <country>Belgium</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Tracy Vandergraesen, MD</last_name>
      <email>Tracy.VANDERGRAESEN@chu-brugmann.be</email>
    </contact>
    <investigator>
      <last_name>Tracy Vandergraesen, MD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>August 2020</verification_date>
  <study_first_submitted>August 6, 2020</study_first_submitted>
  <study_first_submitted_qc>August 7, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>August 7, 2020</last_update_submitted>
  <last_update_submitted_qc>August 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Brugmann University Hospital</investigator_affiliation>
    <investigator_full_name>BADOT, Valerie</investigator_full_name>
    <investigator_title>Head of rhumatology department</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Arthritis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT04505982
org study id: CHUB-IL6
nct id: NCT04505982
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Interleukin 6 is identified as a cytokine with pro and anti-inflammatory effects, depending
      on the context to which it is exposed, exerting a role in the expansion and activation of T
      lymphocytes, in the survival, expansion and the maturation of B lymphocytes and plasmablasts
      as well as in the regulation of the acute phase response. The IL-6 receptor complex is a
      dimer in which each monomer is composed of an 80 kD subunit, IL-6R or CD126, expressed in
      hepatocytes, leukocytes and in megakaryocytes, which binds IL- 6 and a 130 kD subunit, gp130
      or CD130, which is expressed ubiquitously. Its effects are mediated mainly by the way of
      tyrosine kinases of the Jaks family, and transcription factors of the STATs family.

      The complement system is made up of a set of plasma proteins, cascading through three
      activation pathways (classical, alternate and lectin pathway). This system is considered part
      of innate immunity. It is also part of the acute phase response.The complement has several
      functions: cell lysis by formation of the membrane attack complex; opsonization and
      activation of phagocytosis of foreign particles, elimination of circulating immune complexes,
      and regulation of the adaptive immunity response and inflammation via anaphylatoxins.

      After reviewing the literature, the link between IL6 and the complement system can be
      summarized as an induction of factor C3 and factor B, but also probably CD55 (DAF or Decay
      acceleration factor) and CD59 (MAC-IP or MAC-Inhibitory Protein) by interleukin-6. The
      effects of IL-6 on the lectin pathway, on the other hand, seem contradictory: inhibition or
      induction of the synthesis of MASP1 / 3 and 2 depending on the experimental model.

      It has become common knowledge that anti-IL6 receptor monoclonal antibodies, used in the
      treatment of patients with rheumatoid arthritis and other inflammatory conditions, reduce the
      serum levels of acute phase proteins and in particular the levels of CRP. But what about
      other acute phase proteins and in particular the complement ?

      A recent study showed that the serum levels of the complement components C3 and C4 were also
      reduced after the use of tocilizumab and this as early as 4 weeks after the first
      administration. To the investigator's knowledge, this is the only study reporting a decrease
      in complement during treatment with anti-IL6R.

      This study would allow the evaluation of complement parameters in the population of patients
      under treatment with antiIL6R (tocilizumab or sarilumab) within the CHU Brugmann Hospital in
      order to

        -  confirm or not this observation

        -  look for a possible secondary clinical consequence

        -  compare this decrease with the activity of the disease in order to see if it could be a
           marker of effectiveness

        -  put this decrease in parallel with the side effects / tolerance of the treatment in
           order to see if it could be a marker of toxicity / safety

      This study will also investigate the subpopulations of B lymphocytes (memory B, transitional
      B, and plasmablasts) in order to assess whether the evolution of one of these lines would be
      predictive of a therapeutic response.

      Secondly, this study would eventually allow

        -  to improve the understanding of the mechanisms of action of the treatment on
           inflammatory markers by evaluating the activity of the residual complement

        -  to raise the need to find new parameters for monitoring inflammatory activity in these
           patients, since CRP assays are not very helpful.
observational model: Cohort
time perspective: Prospective
measure: Demographic data
time frame: 5 minutes
description: Age, sex
measure: Body Mass Index
time frame: 5 minutes
description: Body Mass Index
measure: Medical History (descriptive listing)
time frame: 5 minutes
description: Medical History (descriptive listing)
measure: Neoplasia
time frame: 5 minutes
description: Active neoplasia, or neoplasia dated less than 5 years
measure: Disease Activity Score Calculator for Rheumatoid Arthritis- DAS28VS
time frame: 5 minutes
description: The DAS28 is a measure of disease activity in rheumatoid arthritis . DAS stands for 'disease activity score' and the number 28 refers to the 28 joints that are examined in this assessment. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
measure: Disease Activity Score Calculator for Rheumatoid Arthritis- DAS28CRP
time frame: 5 minutes
description: The DAS28 is a measure of disease activity in rheumatoid arthritis . DAS stands for 'disease activity score' and the number 28 refers to the 28 joints that are examined in this assessment. A DAS28 of greater than 5.1 implies active disease, less than 3.2 low disease activity, and less than 2.6 remission.
measure: Health Assessment Questionnaire (HAQ)
time frame: 5 minutes
description: The Health Assessment Questionnaire Disability Index (HAQ) is developed for the assessment of disability in patients with Rheumatoid Arthritis. It focuses on two dimensions of health status, physical disability (eight categories), and pain. The eight categories review a total of 20 specific functions and evaluate patient's difficulty with activities of daily living over the past week.
measure: Concomitant medication (descriptive listing)
time frame: 5 minutes
description: Concomitant medication (descriptive listing)
measure: Adverse events linked to the medication (descriptive listing)
time frame: 5 minutes
description: Adverse events linked to the medication (descriptive listing)
measure: Hemogram: normal (yes/no)
time frame: 5 minutes
description: A hemogram contains all of the pertinent information required for assessment of hematopoiesis as well as a visual assessment of plasma appearance and measurement of total solids (an estimate of total protein) in plasma.
measure: Leukocyte count
time frame: 5 minutes
description: Leukocyte count
measure: Blood Ionogram: normal (yes/no)
time frame: 5 minutes
description: The blood ionogram analyses the ionic composition of the blood
measure: Renal function: normal (yes/no)
time frame: 5 minutes
description: Renal function
measure: Hepatic function: normal (yes/no)
time frame: 5 minutes
description: Hepatic function
measure: Parathyroid hormone count
time frame: 5 minutes
description: Parathyroid hormone count
measure: Vitamin D count
time frame: 5 minutes
description: Vitamin D count
measure: Lipid balance: normal (yes/no)
time frame: 5 minutes
description: Lipid balance allows monitoring of cholesterol (LDL-cholesterol and HDL-cholesterol) and triglycerides
measure: Glucose concentration in the blood
time frame: 5 minutes
description: Glucose concentration in the blood
measure: Rheumatoid factor concentration
time frame: 5 minutes
description: Rheumatoid factor is an autoantibody that induces inflammation and damage to the joints.
measure: AntiCCP antibodies count
time frame: 5 minutes
description: The detection of anti-CCP antibodies is used to help diagnose and prognosticate rheumatoid arthritis and differentiate it from other types of arthritis
measure: FAN count
time frame: 5 minutes
description: FAN are autoantibodies against elements of the nucleus
measure: Sedimentation rate
time frame: 5 minutes
description: Sedimentation rate
measure: CRP count
time frame: 5 minutes
description: CRP count
measure: Complement fraction C1q count
time frame: 5 minutes
description: Complement fraction C1q count
measure: Complement fraction C3 count
time frame: 5 minutes
description: Complement fraction C3 count
measure: Complement fraction C3d count
time frame: 5 minutes
description: Complement fraction C3d count
measure: Complement fraction C3a count
time frame: 5 minutes
description: Complement fraction C3a count
measure: Complement fraction C4 count
time frame: 5 minutes
description: Complement fraction C4 count
measure: Complement fraction C4a count
time frame: 5 minutes
description: Complement fraction C4a count
measure: Complement fraction CH50 count
time frame: 5 minutes
description: Complement fraction CH50 count
measure: Complement fraction FB count
time frame: 5 minutes
description: Complement fraction FB count
measure: Lectin count
time frame: 5 minutes
description: Lectin count
measure: Lectin complement pathway serine protease 2 (MASP-2) count
time frame: 5 minutes
description: Lectin complement pathway serine protease 2 (MASP-2) count
measure: Mannose Binding lectin (MBL) count
time frame: 5 minutes
description: Mannose Binding lectin (MBL) count
measure: Complement SC5b9 count
time frame: 5 minutes
description: Complement SC5b9 count
measure: Fibrinogen count
time frame: 5 minutes
description: Fibrinogen count
measure: Lymphocyte B count: memory cells
time frame: 5 minutes
description: Lymphocyte B count: memory cells
measure: Lymphocyte B count: transitional cells
time frame: 5 minutes
description: Lymphocyte B count: transitional cells
measure: Lymphocyte B count: plasmablast cells
time frame: 5 minutes
description: Lymphocyte B count: plasmablast cells
arm group label: Tocilizumab intravenous
description: Patients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with tocilizumab, intravenous
arm group label: Tocilizumab subcutaneous
description: Patients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with tocilizumab, subcutaneous
arm group label: Sarilumab subcutaneous
description: Patients followed in the CHU Brugmann Hospital for a rheumatoid polyarthritis and treated according to standard of care with sarilumab, subcutaneous
intervention type: Other
intervention name: Data extraction from medical files
description: Data extraction from medical files
arm group label: Sarilumab subcutaneous
arm group label: Tocilizumab intravenous
arm group label: Tocilizumab subcutaneous
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
last name: Tracy Vandergraesen, MD
role: Principal Investigator
affiliation: CHU Brugmann
last name: Tracy Vandergraesen, MD
phone: 003224754508
email: Tracy.VANDERGRAESEN@chu-brugmann.be
facility: 
status: Recruiting
contact: 
investigator: 
country: Belgium
responsible party type: Sponsor-Investigator
investigator affiliation: Brugmann University Hospital
investigator full name: BADOT, Valerie
investigator title: Head of rhumatology department
mesh term: Arthritis
sharing ipd: No