<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/NCT03841279</url>
  </required_header>
  <id_info>
    <org_study_id>18-005455</org_study_id>
    <nct_id>NCT03841279</nct_id>
  </id_info>
  <brief_title>Utilizing MRI for Earlier Diagnosis of Rheumatoid Arthritis</brief_title>
  <official_title>Utilizing MRI for Earlier Diagnosis of Rheumatoid Arthritis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Mayo Clinic</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Mayo Clinic</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      MRI has been shown to be helpful in identifying patients who present with undifferentiated&#xD;
      inflammatory arthritis who will develop RA within a one year follow up period. The absence of&#xD;
      other clinically apparent symptoms often causes delays in diagnosis of RA. The use of the MRI&#xD;
      in conjunction with the physical examination has the potential to reduce diagnostic delay.&#xD;
      Earlier diagnosis would allow for earlier treatment implementation for better patient&#xD;
      outcomes.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">January 1, 2019</start_date>
  <completion_date type="Anticipated">December 2023</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Earlier Diagnosis of RA if MRI is utilized</measure>
    <time_frame>1 year</time_frame>
    <description>To determine if MRI is predictive of later development of RA in patients with undifferentiated inflammatory arthritis; patients with inflammatory arthritis who receive an MRI will have earlier initiation of treatment</description>
  </primary_outcome>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Rheumatoid Arthritis</condition>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>MRI</intervention_name>
    <description>Magnetic resonance imaging (MRI) produces detailed images of the body's internal structures without relying on radiation. It is used to diagnose and also gauge efficacy of treatment.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        The target population for this study will be patients with undifferentiated inflammatory&#xD;
        arthritis or seronegative rheumatoid arthritis from the outpatient practice of the Division&#xD;
        of Rheumatology in Rochester, MN.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        ≥ 18 years old&#xD;
&#xD;
        Undifferentiated inflammatory arthritis suspected to be early RA (≥1 joint with synovitis&#xD;
        and ≥1 other tender joint)&#xD;
&#xD;
        Symptom duration ≤1 year&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Unwillingness or inability to return to Mayo Clinic Rochester for research follow-up visits&#xD;
&#xD;
        Current or previous use of DMARDS&#xD;
&#xD;
        Taking ≥10 mg of prednisone a day&#xD;
&#xD;
        Contraindications to contract enhanced MRI&#xD;
&#xD;
        History of another definite autoimmune or inflammatory rheumatic disease&#xD;
&#xD;
        History of psoriasis&#xD;
&#xD;
        History of inflammatory bowel disease&#xD;
&#xD;
        Unsuitably as deemed by the principal investigator&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Kerry Wright, MBBS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Mayo Clinic</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Mayo Clinic</name>
      <address>
        <city>Rochester</city>
        <state>Minnesota</state>
        <zip>55905</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <link>
    <url>https://www.mayo.edu/research/clinical-trials</url>
    <description>Mayo Clinic Clinical Trials</description>
  </link>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>February 12, 2019</study_first_submitted>
  <study_first_submitted_qc>February 12, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>August 1, 2023</last_update_submitted>
  <last_update_submitted_qc>August 1, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Mayo Clinic</investigator_affiliation>
    <investigator_full_name>Kerry Wright</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </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>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/NCT03841279
org study id: 18-005455
nct id: NCT03841279
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
MRI has been shown to be helpful in identifying patients who present with undifferentiated
      inflammatory arthritis who will develop RA within a one year follow up period. The absence of
      other clinically apparent symptoms often causes delays in diagnosis of RA. The use of the MRI
      in conjunction with the physical examination has the potential to reduce diagnostic delay.
      Earlier diagnosis would allow for earlier treatment implementation for better patient
      outcomes.
observational model: Cohort
time perspective: Prospective
measure: Earlier Diagnosis of RA if MRI is utilized
time frame: 1 year
description: To determine if MRI is predictive of later development of RA in patients with undifferentiated inflammatory arthritis; patients with inflammatory arthritis who receive an MRI will have earlier initiation of treatment
intervention type: Diagnostic Test
intervention name: MRI
description: Magnetic resonance imaging (MRI) produces detailed images of the body's internal structures without relying on radiation. It is used to diagnose and also gauge efficacy of treatment.
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Kerry Wright, MBBS
role: Principal Investigator
affiliation: Mayo Clinic
facility: 
country: United States
url: https://www.mayo.edu/research/clinical-trials
description: Mayo Clinic Clinical Trials
responsible party type: Principal Investigator
investigator affiliation: Mayo Clinic
investigator full name: Kerry Wright
investigator title: Principal Investigator
mesh term: Arthritis
mesh term: Arthritis, Rheumatoid
sharing ipd: No