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The CARRA Registry

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by Duke University
Sponsor:
Collaborators:
Information provided by (Responsible Party):
Duke University
ClinicalTrials.gov Identifier:
NCT01697254
First received: September 28, 2012
Last updated: March 17, 2014
Last verified: March 2014
  Purpose

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.


Condition
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

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 ] [ 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.


Estimated Enrollment: 10000
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)
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

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 ClinicalTrials.gov identifier: NCT01697254

Locations
United States, North Carolina
Duke Clinical Research Institute Recruiting
Durham, North Carolina, United States, 27705
Contact: Laura Schanberg, MD    919-684-6575      
Principal Investigator: Laura Schanberg, MD         
Sponsors and Collaborators
Duke University
Investigators
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

Publications:

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT01697254     History of Changes
Other Study ID Numbers: Pro00018979, 1RC2AE058934-01
Study First Received: September 28, 2012
Last Updated: March 17, 2014
Health Authority: United States: Federal Government
United States: Food and Drug Administration
United States: Institutional Review Board

Additional relevant MeSH terms:
Dermatomyositis
Arthritis, Juvenile
Connective Tissue Diseases
Fibromyalgia
Lupus Erythematosus, Systemic
Mixed Connective Tissue Disease
Myofascial Pain Syndromes
Scleroderma, Diffuse
Scleroderma, Localized
Scleroderma, Systemic
Spondylitis
Spondylitis, Ankylosing
Vasculitis
Ankylosis
Arthritis
Autoimmune Diseases
Bone Diseases
Bone Diseases, Infectious
Cardiovascular Diseases
Immune System Diseases
Infection
Joint Diseases
Muscular Diseases
Musculoskeletal Diseases
Myositis
Nervous System Diseases
Neuromuscular Diseases
Polymyositis
Rheumatic Diseases
Skin Diseases

ClinicalTrials.gov processed this record on November 23, 2014