<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/NCT04474392</url>
  </required_header>
  <id_info>
    <org_study_id>20-0206</org_study_id>
    <secondary_id>1R01AR076450-01</secondary_id>
    <nct_id>NCT04474392</nct_id>
  </id_info>
  <brief_title>Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins</brief_title>
  <acronym>SPARO</acronym>
  <official_title>Sputum Studies of Anti-Citrullinated Protein Antibodies (ACPA) and Rheumatoid Arthritis (RA) Origins</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institutes of Health (NIH)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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>
      The study is designed to learn more about the causes of rheumatoid arthritis (RA). People who&#xD;
      get RA have elevated protein markers called autoantibodies in their blood years before&#xD;
      initial symptoms of arthritis. The goal of this study is to learn more about how&#xD;
      autoantibodies in RA might be related to inflammation in the lungs.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The Specific Aims of This Study Are As Follows:&#xD;
&#xD;
        1. Identify whether sputum anti-CCP predicts incident RA&#xD;
&#xD;
        2. Determine the effect of inflammatory cytokines on the induction of NETosis in sputum&#xD;
           neutrophils&#xD;
&#xD;
        3. Determine the role of sputum macrophage phagocytosis in NET clearance &lt;br&gt; The knowledge&#xD;
           gained from this study will improve the overall understanding of the development of RA.&#xD;
           It is anticipated that these findings will improve the field's understanding of how best&#xD;
           to screen for RA risk and target RA prevention. This study could support future&#xD;
           lung-targeted prevention strategies for RA that could avoid the administration of&#xD;
           systemic toxic therapies. Such potential prevention interventions could be implemented&#xD;
           in subjects at risk for RA in order to prevent the irreversible joint damage that can&#xD;
           occur in the later stages of clinically-apparent RA.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Anticipated">July 14, 2025</completion_date>
  <primary_completion_date type="Anticipated">July 14, 2025</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>Sputum anti-CCP antibodies predicting incident RA</measure>
    <time_frame>1-3 years per participant (depending on group); study visits x1 per year, with option for 3 additional visits over 1 year for a subgroup of participants.</time_frame>
    <description>*Sputum anti-CCP antibodies every year for 3 years (subjects At-Risk for RA); to identify whether sputum anti-CCP predicts incident RA</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils</measure>
    <time_frame>1-3 yrs / participant; At-Risk Group: Baseline Visit &amp; 2 Follow-up Annual Visits (w/ potential to have 3 additional visits in 1 year); Healthy Controls &amp; RA Diagnosed: Baseline Visit &amp; 1 Follow-up Visit, approximately 1 year later</time_frame>
    <description>*Determine the effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The role of sputum macrophage phagocytosis in NET clearance</measure>
    <time_frame>1-3 years / participant; At-Risk Group: Baseline Visit &amp; 2 Follow-up Annual Visits (w/ potential to have 3 additional visits in 1 year); Healthy Controls &amp; RA Diagnosed: Baseline Visit &amp; 1 Follow-up Visit, approximately 1 year later</time_frame>
    <description>*Determine the role of sputum macrophage phagocytosis in NET clearance among At-Risk, healthy, &amp; RA subjects</description>
  </secondary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Anticipated">340</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <arm_group>
    <arm_group_label>At-Risk (N=180)</arm_group_label>
    <description>No evidence of inflammatory arthritis on clinical examination AND&#xD;
At elevated risk for RA based on familial or serologic risk&#xD;
Familial risk includes having a first degree relatives (FDRs) with RA&#xD;
Serologic risk includes asymptomatic serum ACPA positivity&#xD;
There will be 1 study visit per year for 3 years; for a subset of 30 of these participants, there will be an additional 3 quarterly visits in one year.&#xD;
Study Procedures (Baseline &amp; Follow-up):&#xD;
Questionnaires&#xD;
Physical and joint exam&#xD;
Measurement of participants' height, weight&#xD;
Blood and sputum collection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Healthy Controls (N=120)</arm_group_label>
    <description>No history of RA&#xD;
No FDRs with RA&#xD;
No systemic use of immunosuppressants for autoimmune disease&#xD;
Participants will return for 1 follow-up visit, approximately 1 year after their baseline visit.&#xD;
Study Procedures (Baseline &amp; Follow-up):&#xD;
Questionnaires&#xD;
Physical and joint exam&#xD;
Measurement of participants' height, weight&#xD;
Blood and sputum collection</description>
  </arm_group>
  <arm_group>
    <arm_group_label>RA Diagnosis (N=40)</arm_group_label>
    <description>Classified RA by 1987 ACR and/or 2010 ACR/EULAR RA classification criteria (confirmed by medical chart review) OR&#xD;
Diagnosed with RA by a board-certified rheumatologist (confirmed by medical chart review)&#xD;
Participants will return for 1 follow-up visit, approximately 1 year after their baseline visit.&#xD;
Study Procedures (Baseline &amp; Follow-up):&#xD;
Questionnaires&#xD;
Physical and joint exam&#xD;
Measurement of participants' height, weight&#xD;
Blood and sputum collection</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>N/A (Observational Study)</intervention_name>
    <description>Observational study, no intervention will be administered.</description>
    <arm_group_label>At-Risk (N=180)</arm_group_label>
    <arm_group_label>Healthy Controls (N=120)</arm_group_label>
    <arm_group_label>RA Diagnosis (N=40)</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood, saliva, and sputum samples are collected for this study. The blood, saliva, and sputum&#xD;
      samples are stored in -80 freezers at the Barbara Davis Center.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        We will recruit subjects from 1) the Denver site of the SERA project (COMIRB #01-0675); 2)&#xD;
        local rheumatology clinics, including the University of Colorado Hospital (UCH), Denver&#xD;
        Health, National Jewish Health (NJH), and the Denver Arthritis Clinic; 3) local health&#xD;
        clinics at UCH; and 4) local advertisements.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adults between 18 and 100 years;&#xD;
&#xD;
          -  At-Risk for RA, RA diagnosed, and Healthy Control subjects will be included in the&#xD;
             study until recruitment goals are met for each group.&#xD;
&#xD;
        At-Risk:&#xD;
&#xD;
          1. No evidence of inflammatory arthritis on clinical examination AND&#xD;
&#xD;
          2. At elevated risk for RA based on familial or serologic risk&#xD;
&#xD;
               -  Familial risk includes having a first degree relatives (FDRs) with RA&#xD;
&#xD;
               -  Serologic risk includes asymptomatic serum ACPA positivity&#xD;
&#xD;
        Healthy Controls :&#xD;
&#xD;
          1. No history of RA&#xD;
&#xD;
          2. No FDRs with RA&#xD;
&#xD;
          3. No systemic use of immunosuppressants for autoimmune disease&#xD;
&#xD;
        RA Diagnosis:&#xD;
&#xD;
          1. Classified RA by 1987 ACR and/or 2010 ACR/EULAR RA classification criteria (confirmed&#xD;
             by medical chart review) OR&#xD;
&#xD;
          2. Diagnosed with RA by a board-certified rheumatologist (confirmed by medical chart&#xD;
             review)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Currently pregnant or planning to become pregnant during the sample collection period&#xD;
             of the study&#xD;
&#xD;
          2. Exacerbation of underlying obstructive lung disease within the past 1 month&#xD;
&#xD;
          3. Known FEV1 &lt;1 liter&#xD;
&#xD;
          4. Oxygen requirement &gt;2 liters at rest&#xD;
&#xD;
          5. Participants with health acuity or behavioral health concerns leaving them unable to&#xD;
             participate in the current research&#xD;
&#xD;
        Note: If a subject temporarily does not meet inclusion criteria but is interested in&#xD;
        participating, he/she may participate once inclusion criteria have been met.&#xD;
&#xD;
        If interested, please take a few minutes to complete the screening questionnaire for this&#xD;
        study opportunity. You may open the survey in your web browser by clicking the link below:&#xD;
&#xD;
        https://is.gd/SPAROscreen&#xD;
&#xD;
        If the link above does not work, try copying the link below into your web browser:&#xD;
&#xD;
        https://redcap.ucdenver.edu/surveys/?s=3WM8WH3WKK&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kristen Demoruelle, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Colorado, Denver</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Kasey Bales</last_name>
    <phone>303-724-0071</phone>
    <email>KASEY.BALES@CUANSCHUTZ.EDU</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Kristin Sturm, MA</last_name>
    <phone>303-724-5658</phone>
    <email>KRISTIN.STURM@CUANSCHUTZ.EDU</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>University of Colorado Denver (Anschutz Medical Campus)</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Kasey Bales</last_name>
      <phone>303-724-0071</phone>
      <email>KASEY.BALES@CUANSCHUTZ.EDU</email>
    </contact>
    <contact_backup>
      <last_name>Kristin Sturm, MA</last_name>
      <phone>303-724-5658</phone>
      <email>KRISTIN.STURM@CUANSCHUTZ.EDU</email>
    </contact_backup>
    <investigator>
      <last_name>Kristen Demoruelle, MD, PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
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  <verification_date>June 2022</verification_date>
  <study_first_submitted>June 29, 2020</study_first_submitted>
  <study_first_submitted_qc>July 15, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 16, 2020</study_first_posted>
  <last_update_submitted>June 13, 2022</last_update_submitted>
  <last_update_submitted_qc>June 13, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">June 14, 2022</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>
  </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/NCT04474392
org study id: 20-0206
secondary id: 1R01AR076450-01
nct id: NCT04474392
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study is designed to learn more about the causes of rheumatoid arthritis (RA). People who
      get RA have elevated protein markers called autoantibodies in their blood years before
      initial symptoms of arthritis. The goal of this study is to learn more about how
      autoantibodies in RA might be related to inflammation in the lungs.
The Specific Aims of This Study Are As Follows:

        1. Identify whether sputum anti-CCP predicts incident RA

        2. Determine the effect of inflammatory cytokines on the induction of NETosis in sputum
           neutrophils

        3. Determine the role of sputum macrophage phagocytosis in NET clearance <br> The knowledge
           gained from this study will improve the overall understanding of the development of RA.
           It is anticipated that these findings will improve the field's understanding of how best
           to screen for RA risk and target RA prevention. This study could support future
           lung-targeted prevention strategies for RA that could avoid the administration of
           systemic toxic therapies. Such potential prevention interventions could be implemented
           in subjects at risk for RA in order to prevent the irreversible joint damage that can
           occur in the later stages of clinically-apparent RA.
observational model: Cohort
time perspective: Prospective
measure: Sputum anti-CCP antibodies predicting incident RA
time frame: 1-3 years per participant (depending on group); study visits x1 per year, with option for 3 additional visits over 1 year for a subgroup of participants.
description: *Sputum anti-CCP antibodies every year for 3 years (subjects At-Risk for RA); to identify whether sputum anti-CCP predicts incident RA
measure: Effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils
time frame: 1-3 yrs / participant; At-Risk Group: Baseline Visit & 2 Follow-up Annual Visits (w/ potential to have 3 additional visits in 1 year); Healthy Controls & RA Diagnosed: Baseline Visit & 1 Follow-up Visit, approximately 1 year later
description: *Determine the effect of inflammatory cytokines on the induction of NETosis in sputum neutrophils
measure: The role of sputum macrophage phagocytosis in NET clearance
time frame: 1-3 years / participant; At-Risk Group: Baseline Visit & 2 Follow-up Annual Visits (w/ potential to have 3 additional visits in 1 year); Healthy Controls & RA Diagnosed: Baseline Visit & 1 Follow-up Visit, approximately 1 year later
description: *Determine the role of sputum macrophage phagocytosis in NET clearance among At-Risk, healthy, & RA subjects
arm group label: At-Risk (N=180)
description: No evidence of inflammatory arthritis on clinical examination AND
At elevated risk for RA based on familial or serologic risk
Familial risk includes having a first degree relatives (FDRs) with RA
Serologic risk includes asymptomatic serum ACPA positivity
There will be 1 study visit per year for 3 years; for a subset of 30 of these participants, there will be an additional 3 quarterly visits in one year.
Study Procedures (Baseline & Follow-up):
Questionnaires
Physical and joint exam
Measurement of participants' height, weight
Blood and sputum collection
arm group label: Healthy Controls (N=120)
description: No history of RA
No FDRs with RA
No systemic use of immunosuppressants for autoimmune disease
Participants will return for 1 follow-up visit, approximately 1 year after their baseline visit.
Study Procedures (Baseline & Follow-up):
Questionnaires
Physical and joint exam
Measurement of participants' height, weight
Blood and sputum collection
arm group label: RA Diagnosis (N=40)
description: Classified RA by 1987 ACR and/or 2010 ACR/EULAR RA classification criteria (confirmed by medical chart review) OR
Diagnosed with RA by a board-certified rheumatologist (confirmed by medical chart review)
Participants will return for 1 follow-up visit, approximately 1 year after their baseline visit.
Study Procedures (Baseline & Follow-up):
Questionnaires
Physical and joint exam
Measurement of participants' height, weight
Blood and sputum collection
intervention type: Other
intervention name: N/A (Observational Study)
description: Observational study, no intervention will be administered.
arm group label: At-Risk (N=180)
arm group label: Healthy Controls (N=120)
arm group label: RA Diagnosis (N=40)
Blood, saliva, and sputum samples are collected for this study. The blood, saliva, and sputum
      samples are stored in -80 freezers at the Barbara Davis Center.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Kristen Demoruelle, MD, PhD
role: Principal Investigator
affiliation: University of Colorado, Denver
last name: Kasey Bales
phone: 303-724-0071
email: KASEY.BALES@CUANSCHUTZ.EDU
last name: Kristin Sturm, MA
phone: 303-724-5658
email: KRISTIN.STURM@CUANSCHUTZ.EDU
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
country: United States
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responsible party type: Sponsor
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: Undecided