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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

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.

Condition or disease
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

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.

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Study Type : Observational [Patient Registry]
Actual Enrollment : 9587 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The CARRA Registry
Study Start Date : August 2009
Actual Primary Completion Date : October 2015
Actual Study Completion Date : October 2015

Primary Outcome Measures :
  1. Enrolled Subjects [ Time Frame: baseline ]
    This is an observational registry. The primary outcome is the # of subjects enrolled with pediatric rheumatic disease.

Biospecimen Retention:   Samples With DNA
Specimens currently being collected from subjects with juvenile dermatomyositis JDM), systemic juvenile idiopathic arthritis (sJIA), and localized scleroderma.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects will be recruited from the patient population of a CARRA Registry site.

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01697254

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United States, North Carolina
Duke Clinical Research Institute
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
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
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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
Additional Information:

Publications of Results:

Other Publications:
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Duke University Identifier: NCT01697254    
Other Study ID Numbers: Pro00018979
First Posted: October 2, 2012    Key Record Dates
Last Update Posted: November 17, 2015
Last Verified: November 2015
Additional relevant MeSH terms:
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Spondylitis, Ankylosing
Arthritis, Juvenile
Lupus Erythematosus, Systemic
Scleroderma, Systemic
Connective Tissue Diseases
Scleroderma, Localized
Mixed Connective Tissue Disease
Joint Diseases
Musculoskeletal Diseases
Muscular Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Bone Diseases, Infectious
Bone Diseases
Spinal Diseases
Uveal Diseases
Eye Diseases