<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/NCT03276923</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00084014</org_study_id>
    <nct_id>NCT03276923</nct_id>
  </id_info>
  <brief_title>Maternal Autoimmune Disease Research Alliance (MADRA) Registry</brief_title>
  <acronym>MADRA</acronym>
  <official_title>Maternal Autoimmune Disease Research Alliance (MADRA) Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Duke 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>
      This multi-site registry, centered at Duke University, will enroll pregnant women with&#xD;
      autoimmune and rheumatologic diseases.&#xD;
&#xD;
      The main goal of MADRA is to identify ways to improve the health of women with rheumatic&#xD;
      diseases and their babies during pregnancy.&#xD;
&#xD;
      Prior studies demonstrate the importance of increase inflammation prior to and during&#xD;
      pregnancy on these outcomes. The future research will seek to better define these risk&#xD;
      factors and to identify ways to may improve them.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      At each site, the patients will be under the care of the participating rheumatologist and&#xD;
      their local obstetrician during the pregnancy. This is a natural-history study and will not&#xD;
      include medications, laboratory testing, or procedures outside of the standard of care.&#xD;
&#xD;
      Management of the rheumatologic disease will be directed based on patient needs by the local&#xD;
      rheumatologist and obstetrician. Enrollment in the registry will not dictate specific&#xD;
      therapy. The Registry will include data from each office visit during pregnancy and up to 12&#xD;
      months after delivery.&#xD;
&#xD;
      The registry will be ongoing, with periodic analysis of clinical data samples as specific&#xD;
      studies are approved.&#xD;
&#xD;
      Enrollment in the registry does not significantly increase risks for a patient.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Anticipated">January 1, 2027</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2027</primary_completion_date>
  <study_type>Observational [Patient Registry]</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>
  <target_duration>100 Years</target_duration>
  <primary_outcome>
    <measure>Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire.</measure>
    <time_frame>up to 10 years</time_frame>
    <description>The investigators will ask the participants questions from the MADRA-DAP questionnaire to determine poor pregnancy outcomes.</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Autoimmune Diseases</condition>
  <condition>Pregnancy Related</condition>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Cutaneous Lupus</condition>
  <condition>Rheumatoid Arthritis</condition>
  <condition>Sjogren's Syndrome</condition>
  <condition>Scleroderma</condition>
  <arm_group>
    <arm_group_label>Maternal Autoimmune Disease ReseArch (MADRA) Registry</arm_group_label>
    <description>Women with autoimmune diseases who are pregnant</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Blood and urine samples will be collected.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Women who have been diagnosed with an autoimmune disease or a rheumatic condition.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Desire for pregnancy within 6 months or currently pregnant&#xD;
&#xD;
          -  Women with systemic autoimmune disease, including:&#xD;
&#xD;
          -  Lupus (systemic lupus erythematosus or cutaneous lupus)&#xD;
&#xD;
          -  Antiphospholipid Syndrome or positive antiphospholipid antibodies&#xD;
&#xD;
          -  Rheumatoid Arthritis&#xD;
&#xD;
          -  Scleroderma (systemic sclerosis)&#xD;
&#xD;
          -  Sjogren's Syndrome&#xD;
&#xD;
          -  Inflammatory Arthritis (including Psoriatic Arthritis and Ankylosing Spondylitis)&#xD;
&#xD;
          -  Undifferentiated Connective Tissue Disease (UCTD)&#xD;
&#xD;
          -  Vasculitis&#xD;
&#xD;
          -  Myositis (Polymyositis or Dermatomyositis)&#xD;
&#xD;
          -  Positive Ro/SSA or La/SSB antibodies&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Unable to speak English&#xD;
&#xD;
          -  Unable to provide informed consent&#xD;
&#xD;
          -  Unable to travel to Duke University for follow-up visits&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Megan EB Clowse, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke Health</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Laura Neil</last_name>
    <phone>919 684 8936</phone>
    <email>laura.k.neil@duke.edu</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Edna Scarlett</last_name>
    <phone>919-684-6150</phone>
    <email>edna.scarlett@duke.edu</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Duke University</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Megan Clowse, MD</last_name>
      <phone>919-681-2045</phone>
      <email>megan.clowse@duke.edu</email>
    </contact>
    <contact_backup>
      <last_name>Laura Neil</last_name>
      <phone>919 684 8936</phone>
      <email>laura.k.neil@duke.edu</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>August 29, 2017</study_first_submitted>
  <study_first_submitted_qc>September 7, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 8, 2017</study_first_posted>
  <last_update_submitted>February 14, 2023</last_update_submitted>
  <last_update_submitted_qc>February 14, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 16, 2023</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>Sjogren's Syndrome</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    <mesh_term>Autoimmune Diseases</mesh_term>
  </condition_browse>
  <!-- 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/NCT03276923
org study id: Pro00084014
nct id: NCT03276923
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This multi-site registry, centered at Duke University, will enroll pregnant women with
      autoimmune and rheumatologic diseases.

      The main goal of MADRA is to identify ways to improve the health of women with rheumatic
      diseases and their babies during pregnancy.

      Prior studies demonstrate the importance of increase inflammation prior to and during
      pregnancy on these outcomes. The future research will seek to better define these risk
      factors and to identify ways to may improve them.
At each site, the patients will be under the care of the participating rheumatologist and
      their local obstetrician during the pregnancy. This is a natural-history study and will not
      include medications, laboratory testing, or procedures outside of the standard of care.

      Management of the rheumatologic disease will be directed based on patient needs by the local
      rheumatologist and obstetrician. Enrollment in the registry will not dictate specific
      therapy. The Registry will include data from each office visit during pregnancy and up to 12
      months after delivery.

      The registry will be ongoing, with periodic analysis of clinical data samples as specific
      studies are approved.

      Enrollment in the registry does not significantly increase risks for a patient.
observational model: Cohort
time perspective: Prospective
measure: Risk factors associated with poor pregnancy outcomes as measured by the MADRA-DAP questionnaire.
time frame: up to 10 years
description: The investigators will ask the participants questions from the MADRA-DAP questionnaire to determine poor pregnancy outcomes.
arm group label: Maternal Autoimmune Disease ReseArch (MADRA) Registry
description: Women with autoimmune diseases who are pregnant
Blood and urine samples will be collected.
study pop: 
sampling method: Probability Sample
criteria: 
gender: Female
gender based: Yes
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Megan EB Clowse, MD, MPH
role: Principal Investigator
affiliation: Duke Health
last name: Laura Neil
phone: 919 684 8936
email: laura.k.neil@duke.edu
last name: Edna Scarlett
phone: 919-684-6150
email: edna.scarlett@duke.edu
facility: 
status: Recruiting
contact: 
contact backup: 
country: United States
responsible party type: Sponsor
mesh term: Sjogren's Syndrome
mesh term: Lupus Erythematosus, Systemic
mesh term: Autoimmune Diseases