The CARRA Registry (CARRA Registry)
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ClinicalTrials.gov Identifier: NCT01697254 |
Recruitment Status :
Completed
First Posted : October 2, 2012
Last Update Posted : November 17, 2015
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Condition or disease |
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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 |
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] |
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 |

- 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

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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 |
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

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 ClinicalTrials.gov identifier (NCT number): 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 |
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Duke University |
ClinicalTrials.gov Identifier: | NCT01697254 |
Other Study ID Numbers: |
Pro00018979 1RC2AE058934-01 |
First Posted: | October 2, 2012 Key Record Dates |
Last Update Posted: | November 17, 2015 |
Last Verified: | November 2015 |
Spondylitis Fibromyalgia Spondylitis, Ankylosing Arthritis, Juvenile Dermatomyositis Uveitis Vasculitis Lupus Erythematosus, Systemic Scleroderma, Systemic Connective Tissue Diseases Scleroderma, Localized Mixed Connective Tissue Disease Arthritis Joint Diseases Musculoskeletal Diseases |
Muscular Diseases Rheumatic Diseases Neuromuscular Diseases Nervous System Diseases Autoimmune Diseases Immune System Diseases Bone Diseases, Infectious Infection Bone Diseases Spinal Diseases Uveal Diseases Eye Diseases Spondylarthropathies Spondylarthritis Ankylosis |