The CARRA Registry

Systemic Lupus Erythematosus Clinical Trial

— CARRA Registry  

Official title:

The CARRA Registry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01697254
• Other study ID #: Pro00018979
• Secondary ID: 1RC2AE058934-01
• Status: Completed
• Phase: N/A
• First received: September 28, 2012
• Last updated: November 16, 2015
• Start date: August 2009
• Est. completion date: October 2015

Study information

• Verified date: November 2015
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal GovernmentUnited States: Food and Drug AdministrationUnited States: Institutional Review Board
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 9587
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Duke Clinical Research Institute	Durham	North Carolina

Sponsors (6)

Lead Sponsor	Collaborator
Duke University	Arthritis Foundation, Cure JM Foundation, Lupus Foundation of America, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (6)

Beukelman T, Ringold S, Davis TE, DeWitt EM, Pelajo CF, Weiss PF, Kimura Y; CARRA Registry Investigators. Disease-modifying antirheumatic drug use in the treatment of juvenile idiopathic arthritis: a cross-sectional analysis of the CARRA Registry. J Rheum — View Citation

Kimura Y, Weiss JE, Haroldson KL, Lee T, Punaro M, Oliveira S, Rabinovich E, Riebschleger M, Antón J, Blier PR, Gerloni V, Hazen MM, Kessler E, Onel K, Passo MH, Rennebohm RM, Wallace CA, Woo P, Wulffraat N; Childhood Arthritis Rheumatology Research Allia — View Citation

Natter MD, Quan J, Ortiz DM, Bousvaros A, Ilowite NT, Inman CJ, Marsolo K, McMurry AJ, Sandborg CI, Schanberg LE, Wallace CA, Warren RW, Weber GM, Mandl KD. An i2b2-based, generalizable, open source, self-scaling chronic disease registry. J Am Med Inform — View Citation

Ringold S, Beukelman T, Nigrovic PA, Kimura Y; CARRA Registry Site Principal Investigators. Race, ethnicity, and disease outcomes in juvenile idiopathic arthritis: a cross-sectional analysis of the Childhood Arthritis and Rheumatology Research Alliance (C — View Citation

Robinson AB, Hoeltzel MF, Wahezi DM, Becker ML, Kessler EA, Schmeling H, Carrasco R, Huber AM, Feldman BM, Reed AM; Juvenile Myositis CARRA Subgroup, for the CARRA Registry Investigators. Clinical characteristics of children with juvenile dermatomyositis: the Childhood Arthritis and Rheumatology Research Alliance Registry. Arthritis Care Res (Hoboken). 2014 Mar;66(3):404-10. doi: 10.1002/acr.22142. — View Citation

Weiss PF, Beukelman T, Schanberg LE, Kimura Y, Colbert RA; CARRA Registry Investigators. Enthesitis-related arthritis is associated with higher pain intensity and poorer health status in comparison with other categories of juvenile idiopathic arthritis: t — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Enrolled Subjects	This is an observational registry. The primary outcome is the # of subjects enrolled with pediatric rheumatic disease.	baseline	No