Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
NCT ID: NCT02418442
Last Updated: 2025-10-14
Study Results
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Basic Information
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RECRUITING
20000 participants
OBSERVATIONAL
2015-07-31
2028-12-31
Brief Summary
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Detailed Description
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Continuation of the CARRA Registry as described in this protocol will support data collection on patients with pediatric-onset rheumatic diseases. The CARRA Registry will form the basis for future CARRA studies. In particular, this observational registry will be used to answer pressing questions about therapeutics used to treat pediatric rheumatic diseases, including examining safety questions. The Duke Clinical Research Institute (DCRI) is serving as the CARRA Clinical and Data Coordinating Center (CDCC) for the protocol.
Traditional exposure-based post-marketing registries of individual therapeutic agents for juvenile idiopathic arthritis (JIA), systemic lupus erythematosus, and other rheumatic diseases are inadequate for answering important safety questions for many reasons:
* Sample sizes are too small to detect uncommon but important events
* No unexposed comparators exist to evaluate risk attributable to underlying disease
* Duration of follow-up of individual patients is too short to evaluate many potential delayed adverse events (AEs)
* Sample sizes are inadequate to assess myriad complex and dynamic concurrent medication regimens common to treatment of rheumatic diseases
* Selective patient enrollment limits evaluation of co-morbid conditions and other patient factors
These limitations prevent patients, families, and providers from understanding the true risks and benefits of therapy in order to make appropriate and informed decisions. They also prevent drug manufacturers and regulatory agencies from conducting an informed review of marketed products for these diseases.
A registry based on disease diagnosis rather than specific therapeutic agents overcomes many of the limitations of exposure-based single-agent registries in the assessment of delayed or uncommon safety events. Indeed, data from a consolidated disease-based registry "...could provide the information necessary for individual companies to satisfy post-marketing requirements and commitments and obviate the need for an individual product registry" (letters from the United States (US) Food and Drug Administration (FDA) to CARRA, 21 December 2010 and 9 December 2011). This protocol details the foundation of a registry to meet these objectives.
The CARRA Registry aims to detect and understand the epidemiology of important AEs, including those that are delayed or uncommon. Subjects followed at active CARRA Registry sites are eligible for enrollment, regardless of past or current treatment. Each subject will be followed prospectively for a goal of 10 years duration; the study will continue indefinitely as resources allow and continued need exists. Data will be systematically collected, including important patient factors, therapies, serious adverse events (SAEs), and protocol-defined events of special interest. Selected safety events (e.g., malignancies) will be adjudicated by a panel of experts via a review of medical records. The CARRA Registry, a disease-based prospective observational registry, enables both detection of potential safety signals and hypothesis-driven, rigorous, and adequately-controlled pharmacoepidemiologic studies of important AEs and their associations with therapeutic agents.
In addition to answering questions about the safety of therapeutics, the data collected in the CARRA Registry are anticipated to serve many other valuable uses. Within the confines of observational study design, the effectiveness of therapeutic agents may be examined for short- and long-term clinical and patient-centered outcomes.
The Registry is the data collection platform for Consensus Treatment Plan (CTP) comparative effectiveness research in pediatric rheumatic disease. Patients enrolled in the Registry may also be eligible to be followed as part of a CTP subset. Examples of CTP projects include:
FiRst line Options for Systemic JIA Treatment (FROST). The purpose of FROST was to compare the effectiveness of CARRA systemic JIA (sJIA) treatment strategies (biologic vs. non-biologic) in achieving clinically inactive disease in patients with new-onset sJIA. Additionally, FROST aimed to compare patient/caregiver reported outcomes between treatment strategies. FROST enrolled new-onset, previously untreated sJIA patients who are starting treatment with one of the 4 sJIA CTPs (glucocorticoid (GC) only; Methotrexate + GC; IL-1 inhibitor + GC; IL-6 + GC). Enrollment will occur over 3 years at all CARRA Registry sites. In addition to routine Registry data collection, patients followed as part of the FROST CTP completed additional questionnaires about their disease status and quality of life.
Medication use for pediatric rheumatic diseases is dynamic and not well characterized. The CARRA Registry represents a powerful data source to follow drug use patterns and provides the opportunity to study predictors of medication use. Important outcomes are likely to be influenced by other factors in addition to therapy (e.g., disease severity) and the CARRA Registry is positioned to help answer these types of questions. Patient-reported outcomes (PROs) generated by patients outside the context of clinical encounters may be collected in the Registry to provide a rich, additional dimension of data to better understand rheumatic diseases. Practitioners may review clinical data from their sites as part of a quality improvement approach to better outcomes.
Analyses of CARRA Registry data aim to provide results to guide the therapeutic decisions made by affected children, families, and providers while improving regulatory efficiency and reducing cost. Ultimately, this approach might serve as a model for successful collaboration between research community networks, industry, and public agencies to promote the effective and efficient evaluation of drugs and devices across the regulatory continuum.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Eligibility Criteria
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Inclusion Criteria
2. Subject (and/or parent/legal guardian when required) is able to provide written informed consent and willing to comply with study procedures.
3. Subject and/or parent/legal guardian is willing to be contacted in the future by study staff.
Exclusion Criteria
21 Years
ALL
No
Sponsors
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Childhood Arthritis and Rheumatology Research Alliance
OTHER
Duke University
OTHER
Responsible Party
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Principal Investigators
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Mara L Becker, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
Duke Clinical Research Insitute
Mary Beth Son, MD
Role: PRINCIPAL_INVESTIGATOR
Boston Children's Hospital
Timothy Beukelman, MD, MSCE
Role: PRINCIPAL_INVESTIGATOR
University of Alabama at Birmingham
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Phoenix Children's Hospital
Phoenix, Arizona, United States
Children's Hospital of Los Angeles
Los Angeles, California, United States
Mattel Children's Hospital at University of California Los Angeles
Los Angeles, California, United States
Stanford University Medical Center
Palo Alto, California, United States
Rady Children's Hospital San Diego
San Diego, California, United States
University of California at San Francisco Medical Center
San Francisco, California, United States
The Children's Hospital of Colorado
Aurora, Colorado, United States
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Yale University
New Haven, Connecticut, United States
Childrens National Medical Center
Washington D.C., District of Columbia, United States
University of Florida - Shand's Children's Hospital
Gainesville, Florida, United States
Nicklaus Children's Hospital
Miami, Florida, United States
Nemours Children's Hospital
Orlando, Florida, United States
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States
Emory Children's Center
Atlanta, Georgia, United States
Georgia Regents University Medical Center
Augusta, Georgia, United States
University of Illinois at Chicago
Chicago, Illinois, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, United States
University of Chicago Medical Center
Chicago, Illinois, United States
Indiana University School of Medicine
Indianapolis, Indiana, United States
The University of Iowa Hospitals and Clinics (University of Iowa Children's Hospital)
Iowa City, Iowa, United States
University of Kansas Medical Center
Kansas City, Kansas, United States
University of Louisville Schoole of Medicine
Louisville, Kentucky, United States
Tufts Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital for Children
Boston, Massachusetts, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Bay State Medical Center
Springfield, Massachusetts, United States
University of Michigan
Ann Arbor, Michigan, United States
Helen Devos Children's Hospital
Grand Rapids, Michigan, United States
West Michigan Rheumatology
Grand Rapids, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Children's Mercy Hospital
Kansas City, Missouri, United States
Saint Louis University School of Medicine
St Louis, Missouri, United States
Saint Louis Children's Hospital
St Louis, Missouri, United States
Hackensack University Medical Center
Hackensack, New Jersey, United States
Goryeb Children's Hospital
Morristown, New Jersey, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
The Pediatric Specialty Center at Saint Barnabas
West Orange, New Jersey, United States
Albany Medical College
Albany, New York, United States
Cohen Children's Medical Center of New York
Lake Success, New York, United States
New York University Langone Medical Center
New York, New York, United States
Hospital for Special Surgery
New York, New York, United States
Columbia University Medical Center
New York, New York, United States
Children's Hospital at Montefiore
New York, New York, United States
University of Rochester
Rochester, New York, United States
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, United States
Levine Children's Hospital / Carolinas Medical Center
Charlotte, North Carolina, United States
Duke Children's Hospital & Health Center
Durham, North Carolina, United States
Wake Forest Baptist Brenner Children's Hospital
Winston-Salem, North Carolina, United States
Sanford Health
Fargo, North Dakota, United States
Akron Children's Hospital
Akron, Ohio, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
UH Rainbox Babies and Children's Hospital
Cleveland, Ohio, United States
Metrohealth Medical Center
Cleveland, Ohio, United States
Cleveland Clinic Foundation
Cleveland, Ohio, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, United States
Penn State Children's Hospital
Hershey, Pennsylvania, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, United States
Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, United States
Hasbro Children's Hospital
Providence, Rhode Island, United States
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, United States
Monroe Carrell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, United States
Baylor College of Medicine Pediatric Immunology Allergy Rheumatology
Houston, Texas, United States
University of Utah Hospitals and Clinics (Primary Children's Hospital)
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Children's Hospital of the King's Daughters
Norfolk, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
University of Wisconsin, American Family Children's Hospital
Madison, Wisconsin, United States
Children's Hospital Of Wisconsin
Wauwatosa, Wisconsin, United States
University of Calgary - Alberta Children's Hospital
Calgary, Alberta, Canada
University of Manitoba - Children's Hospital of Manitoba
Winnipeg, Manitoba, Canada
IWK Health Center
Halifax, Nova Scotia, Canada
The Hospital for Sick Children
Toronto, Ontario, Canada
Schneider Children's Medical Center of Israel
Petah Tikva, , Israel
IRCCS Ospedale Pediatrico Bambino Gesu (OPBG)
Rome, , Italy
San Jorge Children's Hospital
San Juan, , Puerto Rico
Countries
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Central Contacts
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Facility Contacts
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References
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Nigrovic PA, Beukelman T, Tomlinson G, Feldman BM, Schanberg LE, Kimura Y; Childhood Arthritis and Rheumatology Research Alliance Systemic Juvenile Idiopathic Arthritis Consensus Treatment Plan Workgroup. Bayesian comparative effectiveness study of four consensus treatment plans for initial management of systemic juvenile idiopathic arthritis: FiRst-Line Options for Systemic juvenile idiopathic arthritis Treatment (FROST). Clin Trials. 2018 Jun;15(3):268-277. doi: 10.1177/1740774518761367. Epub 2018 Mar 15.
Other Identifiers
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Pro00054616
Identifier Type: -
Identifier Source: org_study_id
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