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The CARRA Registry (CARRA Registry)

This study has been completed.
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 Identifier:
First received: September 28, 2012
Last updated: November 16, 2015
Last verified: November 2015
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.

Juvenile Idiopathic Arthritis
Systemic Lupus Erythematosus
Mixed Connective Tissue Disease
Juvenile Ankylosing Spondylitis
Juvenile Dermatomyositis
Localized Scleroderma
Systemic Sclerosis
Fibromyalgia, Primary
Auto-inflammatory Disease
Idiopathic Uveitis Idiopathic

Study Type: Observational [Patient Registry]
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 10 Years
Official Title: The CARRA Registry

Resource links provided by NLM:

Further study details as provided by Duke University:

Primary Outcome Measures:
  • 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.

Enrollment: 9587
Study Start Date: August 2009
Study Completion Date: October 2015
Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
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.


Ages Eligible for Study:   Child, Adult, Senior
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

  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01697254

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
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
  More Information


Responsible Party: Duke University Identifier: NCT01697254     History of Changes
Other Study ID Numbers: Pro00018979
Study First Received: September 28, 2012
Last Updated: November 16, 2015

Additional relevant MeSH terms:
Lupus Erythematosus, Systemic
Spondylitis, Ankylosing
Scleroderma, Systemic
Scleroderma, Diffuse
Connective Tissue Diseases
Arthritis, Juvenile
Mixed Connective Tissue Disease
Scleroderma, Localized
Muscular Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Neuromuscular Diseases
Nervous System Diseases
Autoimmune Diseases
Immune System Diseases
Spinal Diseases
Bone Diseases
Joint Diseases
Skin Diseases
Uveal Diseases
Eye Diseases processed this record on April 21, 2017