The CARRA Registry
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
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|
- Enrolled Subjects [ Time Frame: baseline ] [ Designated as safety issue: No ]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.
|Study Start Date:||August 2009|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2015 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01697254
|United States, North Carolina|
|Duke Clinical Research Institute|
|Durham, North Carolina, United States, 27705|
|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|