The CARRA Registry (CARRA Registry)

November 16, 2015 updated by: Duke University
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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

9587

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27705
        • Duke Clinical Research Institute

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Enrolled Subjects
Time Frame: baseline
This is an observational registry. The primary outcome is the # of subjects enrolled with pediatric rheumatic disease.
baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
National Institutes of Health (NIH)
Arthritis Foundation
Lupus Foundation of America
Cure JM Foundation

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

September 28, 2012

First Submitted That Met QC Criteria

September 28, 2012

First Posted (ESTIMATE)

October 2, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

November 17, 2015

Last Update Submitted That Met QC Criteria

November 16, 2015

Last Verified

November 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00018979
  • 1RC2AE058934-01

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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