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The CARRA Registry (CARRA Registry)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01697254
Recruitment Status : Completed
First Posted : October 2, 2012
Last Update Posted : November 17, 2015
National Institutes of Health (NIH)
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Arthritis Foundation
Lupus Foundation of America
Cure JM Foundation
Information provided by (Responsible Party):
Duke University

Tracking Information
First Submitted Date September 28, 2012
First Posted Date October 2, 2012
Last Update Posted Date November 17, 2015
Study Start Date August 2009
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 29, 2013)
Enrolled Subjects [ Time Frame: baseline ]
This is an observational registry. The primary outcome is the # of subjects enrolled with pediatric rheumatic disease.
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT01697254 on Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title The CARRA Registry
Official Title The CARRA Registry
Brief Summary 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.
Detailed Description

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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration 10 Years
Biospecimen Retention:   Samples With DNA
Specimens currently being collected from subjects with juvenile dermatomyositis JDM), systemic juvenile idiopathic arthritis (sJIA), and localized scleroderma.
Sampling Method Non-Probability Sample
Study Population Subjects will be recruited from the patient population of a CARRA Registry site.
  • Juvenile Idiopathic Arthritis
  • Systemic Lupus Erythematosus
  • Mixed Connective Tissue Disease
  • Juvenile Ankylosing Spondylitis
  • Juvenile Dermatomyositis
  • Localized Scleroderma
  • Systemic Sclerosis
  • Vasculitis
  • Sarcoid
  • Fibromyalgia, Primary
  • Auto-inflammatory Disease
  • Idiopathic Uveitis Idiopathic
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: November 16, 2015)
Original Estimated Enrollment
 (submitted: September 28, 2012)
Actual Study Completion Date October 2015
Actual Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 18 years for all other rheumatic diseases
  • Subject has been diagnosed with a defined pediatric rheumatic disease including: Mixed Connective Tissue Disease (MCTD), Systemic Lupus Erythematosus (SLE), Primary Sjögren's Syndrome (pSS), Systemic Sclerosis (SS), Juvenile Dermatomyositis (JDM), Localized Scleroderma (LS), Juvenile Idiopathic Arthritis (JIA), Vasculitis, Sarcoid, Auto-inflammatory Diseases, Idiopathic Uveitis (IU), and Juvenile Primary Fibromyalgia Syndrome (JPFS).
  • Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.

Exclusion Criteria:

- None

Sexes Eligible for Study: All
Ages Child, Adult, Older Adult
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
Administrative Information
NCT Number NCT01697254
Other Study ID Numbers Pro00018979
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Duke University
Study Sponsor Duke University
  • National Institutes of Health (NIH)
  • National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
  • Arthritis Foundation
  • Lupus Foundation of America
  • Cure JM Foundation
Principal Investigator: Laura Schanberg, MD Duke University
Principal Investigator: Norman T Illowite, MD Children's Hospital at Montefiore
Principal Investigator: Christy Sandborg, MD Lucile Salter Packard Children's Hospital/Stanford University School of Medicine
Principal Investigator: Carol Wallace, MD Seattle Children's Hospital/ University of Washington School of Medicine
PRS Account Duke University
Verification Date November 2015