<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/NCT01697254</url>
  </required_header>
  <id_info>
    <org_study_id>Pro00018979</org_study_id>
    <secondary_id>1RC2AE058934-01</secondary_id>
    <nct_id>NCT01697254</nct_id>
  </id_info>
  <brief_title>The CARRA Registry</brief_title>
  <acronym>CARRA Registry</acronym>
  <official_title>The CARRA Registry</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Duke University</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>
    <collaborator>
      <agency>Arthritis Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Lupus Foundation of America</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Cure JM Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Duke University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This CARRA Registry study will create a foundational database for rheumatic diseases of&#xD;
      childhood using a novel informatics infrastructure developed as part of the larger clinical&#xD;
      project. The creation of a CARRA-wide informatics infrastructure will enable efficient,&#xD;
      observational, disease-related data capture across all CARRA sites for pediatric rheumatic&#xD;
      diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more data&#xD;
      intensive registries for observational studies, comparative effectiveness research,&#xD;
      pharmaceutical clinical trials and translational research.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This protocol represents one aim of a larger clinical project that will advance the&#xD;
      infrastructure of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) network,&#xD;
      facilitate expanded clinical and translational pediatric research, and rapidly transform the&#xD;
      culture of pediatric rheumatology toward universal participation in research. Through the&#xD;
      creation of sophisticated informatics infrastructure, provision of comprehensive site support&#xD;
      and the engagement of families, patients, and communities, CARRA will provide the opportunity&#xD;
      for affected children at every CARRA site to participate in high quality clinical and&#xD;
      translational research.&#xD;
&#xD;
      The larger clinical project includes development of a CARRA-wide informatics platform with&#xD;
      capabilities for capture, storage, visualization, and secure HIPAA-compliant sharing of&#xD;
      validated disease metrics and relevant subject demographics, utilizing centralized Electronic&#xD;
      Data Capture (EDC) and phone interviews where appropriate, and ontology-based data storage&#xD;
      using a distributed database structure based on the NIH-supported i2b2 (Informatics&#xD;
      Integrating Biology and the Bedside) framework. This will enable efficient, observational,&#xD;
      disease-related data capture across CARRA sites. The CARRA Registry described in this&#xD;
      protocol will form the foundational database and will involve the capture of data including&#xD;
      pediatric rheumatic diseases as described in Appendix A.&#xD;
&#xD;
      The CARRA Registry will support data collection from the use of consensus treatment plans&#xD;
      (CTPs), clinical trials, observational disease registries, comparative effectiveness&#xD;
      research, and other research on patients with pediatric rheumatic disease. The CARRA Registry&#xD;
      will form the basis for future CARRA studies and the Duke Clinical Research Institute (DCRI)&#xD;
      is serving as the CARRA Data Coordinating Center (DCC) for this protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2009</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">October 2015</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>10 Years</target_duration>
  <primary_outcome>
    <measure>Enrolled Subjects</measure>
    <time_frame>baseline</time_frame>
    <description>This is an observational registry. The primary outcome is the # of subjects enrolled with pediatric rheumatic disease.</description>
  </primary_outcome>
  <enrollment type="Actual">9587</enrollment>
  <condition>Juvenile Idiopathic Arthritis</condition>
  <condition>Systemic Lupus Erythematosus</condition>
  <condition>Mixed Connective Tissue Disease</condition>
  <condition>Juvenile Ankylosing Spondylitis</condition>
  <condition>Juvenile Dermatomyositis</condition>
  <condition>Localized Scleroderma</condition>
  <condition>Systemic Sclerosis</condition>
  <condition>Vasculitis</condition>
  <condition>Sarcoid</condition>
  <condition>Fibromyalgia, Primary</condition>
  <condition>Auto-inflammatory Disease</condition>
  <condition>Idiopathic Uveitis Idiopathic</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Specimens currently being collected from subjects with juvenile dermatomyositis JDM),&#xD;
      systemic juvenile idiopathic arthritis (sJIA), and localized scleroderma.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects will be recruited from the patient population of a CARRA Registry site.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 18&#xD;
             years for all other rheumatic diseases&#xD;
&#xD;
          -  Subject has been diagnosed with a defined pediatric rheumatic disease including: Mixed&#xD;
             Connective Tissue Disease (MCTD), Systemic Lupus Erythematosus (SLE), Primary&#xD;
             Sjögren's Syndrome (pSS), Systemic Sclerosis (SS), Juvenile Dermatomyositis (JDM),&#xD;
             Localized Scleroderma (LS), Juvenile Idiopathic Arthritis (JIA), Vasculitis, Sarcoid,&#xD;
             Auto-inflammatory Diseases, Idiopathic Uveitis (IU), and Juvenile Primary Fibromyalgia&#xD;
             Syndrome (JPFS).&#xD;
&#xD;
          -  Subject (and/or parent/legal guardian when required) is able to provide written&#xD;
             informed consent and willing to comply with study procedures.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        - None&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Laura Schanberg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Norman T Illowite, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Children's Hospital at Montefiore</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Christy Sandborg, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Lucile Salter Packard Children's Hospital/Stanford University School of Medicine</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Carol Wallace, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Seattle Children's Hospital/ University of Washington School of Medicine</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke Clinical Research Institute</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27705</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Robinson AB, Hoeltzel MF, Wahezi DM, Becker ML, Kessler EA, Schmeling H, Carrasco R, Huber AM, Feldman BM, Reed AM; Juvenile Myositis CARRA Subgroup, for the CARRA Registry Investigators. Clinical characteristics of children with juvenile dermatomyositis: the Childhood Arthritis and Rheumatology Research Alliance Registry. Arthritis Care Res (Hoboken). 2014 Mar;66(3):404-10. doi: 10.1002/acr.22142.</citation>
    <PMID>23983017</PMID>
  </reference>
  <results_reference>
    <citation>Natter MD, Quan J, Ortiz DM, Bousvaros A, Ilowite NT, Inman CJ, Marsolo K, McMurry AJ, Sandborg CI, Schanberg LE, Wallace CA, Warren RW, Weber GM, Mandl KD. An i2b2-based, generalizable, open source, self-scaling chronic disease registry. J Am Med Inform Assoc. 2013 Jan 1;20(1):172-9. doi: 10.1136/amiajnl-2012-001042. Epub 2012 Jun 25.</citation>
    <PMID>22733975</PMID>
  </results_reference>
  <results_reference>
    <citation>Beukelman T, Ringold S, Davis TE, DeWitt EM, Pelajo CF, Weiss PF, Kimura Y; CARRA Registry Investigators. Disease-modifying antirheumatic drug use in the treatment of juvenile idiopathic arthritis: a cross-sectional analysis of the CARRA Registry. J Rheumatol. 2012 Sep;39(9):1867-74. doi: 10.3899/jrheum.120110. Epub 2012 Aug 1.</citation>
    <PMID>22859354</PMID>
  </results_reference>
  <results_reference>
    <citation>Ringold S, Beukelman T, Nigrovic PA, Kimura Y; CARRA Registry Site Principal Investigators. Race, ethnicity, and disease outcomes in juvenile idiopathic arthritis: a cross-sectional analysis of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. J Rheumatol. 2013 Jun;40(6):936-42. doi: 10.3899/jrheum.121147. Epub 2013 Apr 15.</citation>
    <PMID>23588937</PMID>
  </results_reference>
  <results_reference>
    <citation>Weiss PF, Beukelman T, Schanberg LE, Kimura Y, Colbert RA; CARRA Registry Investigators. Enthesitis-related arthritis is associated with higher pain intensity and poorer health status in comparison with other categories of juvenile idiopathic arthritis: the Childhood Arthritis and Rheumatology Research Alliance Registry. J Rheumatol. 2012 Dec;39(12):2341-51. doi: 10.3899/jrheum.120642. Epub 2012 Oct 15.</citation>
    <PMID>23070991</PMID>
  </results_reference>
  <results_reference>
    <citation>Kimura Y, Weiss JE, Haroldson KL, Lee T, Punaro M, Oliveira S, Rabinovich E, Riebschleger M, Anton J, Blier PR, Gerloni V, Hazen MM, Kessler E, Onel K, Passo MH, Rennebohm RM, Wallace CA, Woo P, Wulffraat N; Childhood Arthritis Rheumatology Research Alliance Carra Net Investigators. Pulmonary hypertension and other potentially fatal pulmonary complications in systemic juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2013 May;65(5):745-52. doi: 10.1002/acr.21889.</citation>
    <PMID>23139240</PMID>
  </results_reference>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>September 28, 2012</study_first_submitted>
  <study_first_submitted_qc>September 28, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 2, 2012</study_first_posted>
  <last_update_submitted>November 16, 2015</last_update_submitted>
  <last_update_submitted_qc>November 16, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">November 17, 2015</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>Spondylitis</mesh_term>
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Spondylitis, Ankylosing</mesh_term>
    <mesh_term>Arthritis, Juvenile</mesh_term>
    <mesh_term>Dermatomyositis</mesh_term>
    <mesh_term>Uveitis</mesh_term>
    <mesh_term>Vasculitis</mesh_term>
    <mesh_term>Lupus Erythematosus, Systemic</mesh_term>
    <mesh_term>Scleroderma, Systemic</mesh_term>
    <mesh_term>Connective Tissue Diseases</mesh_term>
    <mesh_term>Mixed Connective Tissue Disease</mesh_term>
    <mesh_term>Scleroderma, Localized</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/NCT01697254
org study id: Pro00018979
secondary id: 1RC2AE058934-01
nct id: NCT01697254
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
collaborator: 
has dmc: No
This CARRA Registry study will create a foundational database for rheumatic diseases of
      childhood using a novel informatics infrastructure developed as part of the larger clinical
      project. The creation of a CARRA-wide informatics infrastructure will enable efficient,
      observational, disease-related data capture across all CARRA sites for pediatric rheumatic
      diseases. The CARRA Registry study will demonstrate the feasibility of expanding to more data
      intensive registries for observational studies, comparative effectiveness research,
      pharmaceutical clinical trials and translational research.
This protocol represents one aim of a larger clinical project that will advance the
      infrastructure of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) network,
      facilitate expanded clinical and translational pediatric research, and rapidly transform the
      culture of pediatric rheumatology toward universal participation in research. Through the
      creation of sophisticated informatics infrastructure, provision of comprehensive site support
      and the engagement of families, patients, and communities, CARRA will provide the opportunity
      for affected children at every CARRA site to participate in high quality clinical and
      translational research.

      The larger clinical project includes development of a CARRA-wide informatics platform with
      capabilities for capture, storage, visualization, and secure HIPAA-compliant sharing of
      validated disease metrics and relevant subject demographics, utilizing centralized Electronic
      Data Capture (EDC) and phone interviews where appropriate, and ontology-based data storage
      using a distributed database structure based on the NIH-supported i2b2 (Informatics
      Integrating Biology and the Bedside) framework. This will enable efficient, observational,
      disease-related data capture across CARRA sites. The CARRA Registry described in this
      protocol will form the foundational database and will involve the capture of data including
      pediatric rheumatic diseases as described in Appendix A.

      The CARRA Registry will support data collection from the use of consensus treatment plans
      (CTPs), clinical trials, observational disease registries, comparative effectiveness
      research, and other research on patients with pediatric rheumatic disease. The CARRA Registry
      will form the basis for future CARRA studies and the Duke Clinical Research Institute (DCRI)
      is serving as the CARRA Data Coordinating Center (DCC) for this protocol.
observational model: Cohort
time perspective: Prospective
measure: Enrolled Subjects
time frame: baseline
description: This is an observational registry. The primary outcome is the # of subjects enrolled with pediatric rheumatic disease.
Specimens currently being collected from subjects with juvenile dermatomyositis JDM),
      systemic juvenile idiopathic arthritis (sJIA), and localized scleroderma.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Laura Schanberg, MD
role: Principal Investigator
affiliation: Duke University
last name: Norman T Illowite, MD
role: Principal Investigator
affiliation: Children's Hospital at Montefiore
last name: Christy Sandborg, MD
role: Principal Investigator
affiliation: Lucile Salter Packard Children's Hospital/Stanford University School of Medicine
last name: Carol Wallace, MD
role: Principal Investigator
affiliation: Seattle Children's Hospital/ University of Washington School of Medicine
facility: 
country: United States
citation: Robinson AB, Hoeltzel MF, Wahezi DM, Becker ML, Kessler EA, Schmeling H, Carrasco R, Huber AM, Feldman BM, Reed AM; Juvenile Myositis CARRA Subgroup, for the CARRA Registry Investigators. Clinical characteristics of children with juvenile dermatomyositis: the Childhood Arthritis and Rheumatology Research Alliance Registry. Arthritis Care Res (Hoboken). 2014 Mar;66(3):404-10. doi: 10.1002/acr.22142.
PMID: 23983017
citation: Natter MD, Quan J, Ortiz DM, Bousvaros A, Ilowite NT, Inman CJ, Marsolo K, McMurry AJ, Sandborg CI, Schanberg LE, Wallace CA, Warren RW, Weber GM, Mandl KD. An i2b2-based, generalizable, open source, self-scaling chronic disease registry. J Am Med Inform Assoc. 2013 Jan 1;20(1):172-9. doi: 10.1136/amiajnl-2012-001042. Epub 2012 Jun 25.
PMID: 22733975
citation: Beukelman T, Ringold S, Davis TE, DeWitt EM, Pelajo CF, Weiss PF, Kimura Y; CARRA Registry Investigators. Disease-modifying antirheumatic drug use in the treatment of juvenile idiopathic arthritis: a cross-sectional analysis of the CARRA Registry. J Rheumatol. 2012 Sep;39(9):1867-74. doi: 10.3899/jrheum.120110. Epub 2012 Aug 1.
PMID: 22859354
citation: Ringold S, Beukelman T, Nigrovic PA, Kimura Y; CARRA Registry Site Principal Investigators. Race, ethnicity, and disease outcomes in juvenile idiopathic arthritis: a cross-sectional analysis of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry. J Rheumatol. 2013 Jun;40(6):936-42. doi: 10.3899/jrheum.121147. Epub 2013 Apr 15.
PMID: 23588937
citation: Weiss PF, Beukelman T, Schanberg LE, Kimura Y, Colbert RA; CARRA Registry Investigators. Enthesitis-related arthritis is associated with higher pain intensity and poorer health status in comparison with other categories of juvenile idiopathic arthritis: the Childhood Arthritis and Rheumatology Research Alliance Registry. J Rheumatol. 2012 Dec;39(12):2341-51. doi: 10.3899/jrheum.120642. Epub 2012 Oct 15.
PMID: 23070991
citation: Kimura Y, Weiss JE, Haroldson KL, Lee T, Punaro M, Oliveira S, Rabinovich E, Riebschleger M, Anton J, Blier PR, Gerloni V, Hazen MM, Kessler E, Onel K, Passo MH, Rennebohm RM, Wallace CA, Woo P, Wulffraat N; Childhood Arthritis Rheumatology Research Alliance Carra Net Investigators. Pulmonary hypertension and other potentially fatal pulmonary complications in systemic juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2013 May;65(5):745-52. doi: 10.1002/acr.21889.
PMID: 23139240
responsible party type: Sponsor
mesh term: Spondylitis
mesh term: Fibromyalgia
mesh term: Spondylitis, Ankylosing
mesh term: Arthritis, Juvenile
mesh term: Dermatomyositis
mesh term: Uveitis
mesh term: Vasculitis
mesh term: Lupus Erythematosus, Systemic
mesh term: Scleroderma, Systemic
mesh term: Connective Tissue Diseases
mesh term: Mixed Connective Tissue Disease
mesh term: Scleroderma, Localized