The CARRA Registry

NCT01697254 | Completed

• 2 other identifiers: Pro000189791RC2AE058934-01
• Study Type: observational
• Target: 9,587
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Outcome Measures

Primary Outcomes (1)

• Enrolled Subjects

  This is an observational registry. The primary outcome is the # of subjects enrolled with pediatric rheumatic disease.

  baseline

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Subjects will be recruited from the patient population of a CARRA Registry site.

You may qualify if:

• 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.

You may not qualify if:

• \- None

Sponsors & Collaborators

• Duke University: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS): collaborator
• Arthritis Foundation: collaborator
• Lupus Foundation of America: collaborator
• Cure JM Foundation: collaborator

Study Sites (1)

Duke Clinical Research Institute

Durham, North Carolina, 27705, United States

Location

Related Publications (7)

• 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.

  PMID: 23983017 BACKGROUND

• 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 Assoc. 2013 Jan 1;20(1):172-9. doi: 10.1136/amiajnl-2012-001042. Epub 2012 Jun 25.

  PMID: 22733975 RESULT

• 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 Rheumatol. 2012 Sep;39(9):1867-74. doi: 10.3899/jrheum.120110. Epub 2012 Aug 1.

  PMID: 22859354 RESULT

• 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 (CARRA) Registry. J Rheumatol. 2013 Jun;40(6):936-42. doi: 10.3899/jrheum.121147. Epub 2013 Apr 15.

  PMID: 23588937 RESULT

• 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: the Childhood Arthritis and Rheumatology Research Alliance Registry. J Rheumatol. 2012 Dec;39(12):2341-51. doi: 10.3899/jrheum.120642. Epub 2012 Oct 15.

  PMID: 23070991 RESULT

• Kimura Y, Weiss JE, Haroldson KL, Lee T, Punaro M, Oliveira S, Rabinovich E, Riebschleger M, Anton 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 Alliance Carra Net Investigators. Pulmonary hypertension and other potentially fatal pulmonary complications in systemic juvenile idiopathic arthritis. Arthritis Care Res (Hoboken). 2013 May;65(5):745-52. doi: 10.1002/acr.21889.

  PMID: 23139240 RESULT

• Kimura Y, Grevich S, Beukelman T, Morgan E, Nigrovic PA, Mieszkalski K, Graham TB, Ibarra M, Ilowite N, Klein-Gitelman M, Onel K, Prahalad S, Punaro M, Ringold S, Toib D, Van Mater H, Weiss JE, Weiss PF, Schanberg LE; CARRA Registry Investigators. Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans. Pediatr Rheumatol Online J. 2017 Apr 11;15(1):23. doi: 10.1186/s12969-017-0157-1.

  PMID: 28399931 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Specimens currently being collected from subjects with juvenile dermatomyositis JDM), systemic juvenile idiopathic arthritis (sJIA), and localized scleroderma.

MeSH Terms

Conditions

Arthritis, Juvenile; Lupus Erythematosus, Systemic; Mixed Connective Tissue Disease; Dermatomyositis; Scleroderma, Localized; Scleroderma, Systemic; Vasculitis; Sarcoidosis; Fibromyalgia

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Polymyositis; Myositis; Muscular Diseases; Neuromuscular Diseases; Nervous System Diseases; Skin Diseases; Vascular Diseases; Cardiovascular Diseases; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Hypersensitivity, Delayed; Hypersensitivity

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2012
• First Posted: October 2, 2012
• Study Start: August 1, 2009
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: November 17, 2015

Record last verified: 2015-11

Locations

US (1)