Observational Study of Pediatric Rheumatic Diseases: The CARRA Registry
Study Purpose
Continuation of the CARRA Registry as described in the 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 safety questions.
Recruitment Criteria
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Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms |
No |
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Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies. |
Observational [Patient Registry] |
| Eligible Ages | N/A - 21 Years |
| Gender | All |
Inclusion Criteria:
1. Onset of rheumatic disease prior to age 16 years for JIA and onset prior to age 19 years for all other rheumatic diseases (see appendix A). 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:
1. Greater than 21 years of age at the time of enrollment.Trial Details
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Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries. |
NCT02418442 |
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Phase
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use. |
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Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data. |
Duke University |
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Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study. |
Mara L Becker, MD, MSCEMary Beth Son, MDTimothy Beukelman, MD, MSCE |
| Principal Investigator Affiliation | Duke Clinical Research InsituteBoston Children's HospitalUniversity of Alabama at Birmingham |
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Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial. |
Other |
| Overall Status | Recruiting |
| Countries | Canada, Israel, Italy, Puerto Rico, United States |
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Conditions
The disease, disorder, syndrome, illness, or injury that is being studied. |
Rheumatic Joint Disease |
The original Childhood Arthritis & Rheumatology Research Alliance (CARRA) Registry (Protocol Number: CRNT_REGST01) was first established in 2010 to advance alliance infrastructure, facilitate expanded clinical and translational pediatric research, and transform the culture of pediatric rheumatology toward universal participation in research. This original CARRA Registry will be referred to throughout the protocol as the CARRA Legacy Registry. Through the creation of a sophisticated informatics infrastructure, provision of comprehensive site support and the engagement of families, patients, and communities, the CARRA Registry will provide the opportunity for affected children at every CARRA Registry site to participate in high-quality clinical and translational research. 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.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.
Status
Recruiting
Address
University of Alabama at Birmingham
Birmingham, Alabama, 35233
Status
Recruiting
Address
Phoenix Children's Hospital
Phoenix, Arizona, 85254
Status
Not yet recruiting
Address
Children's Hospital of Los Angeles
Los Angeles, California, 90027
Status
Recruiting
Address
Mattel Children's Hospital at University of California Los Angeles
Los Angeles, California, 90095
Status
Recruiting
Address
Stanford University Medical Center
Palo Alto, California, 94304
Status
Recruiting
Address
Rady Children's Hospital San Diego
San Diego, California, 92123
Status
Recruiting
Address
University of California at San Francisco Medical Center
San Francisco, California, 94143
Status
Recruiting
Address
The Children's Hospital of Colorado
Aurora, Colorado, 80045
Status
Recruiting
Address
Connecticut Children's Medical Center
Hartford, Connecticut, 06106
Status
Recruiting
Address
Yale University
New Haven, Connecticut, 06519
Status
Recruiting
Address
Childrens National Medical Center
Washington, District of Columbia, 20010
Status
Recruiting
Address
University of Florida - Shand's Children's Hospital
Gainesville, Florida, 32608
Status
Recruiting
Address
Nicklaus Children's Hospital
Miami, Florida, 33155
Status
Recruiting
Address
Nemours Children's Hospital
Orlando, Florida, 32827
Status
Recruiting
Address
Johns Hopkins All Children's Hospital
Saint Petersburg, Florida, 33701
Status
Recruiting
Address
Emory Children's Center
Atlanta, Georgia, 30322
Status
Recruiting
Address
Georgia Regents University Medical Center
Augusta, Georgia, 30912
Status
Withdrawn
Address
University of Illinois at Chicago
Chicago, Illinois, 60607
Status
Recruiting
Address
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60614
Status
Recruiting
Address
University of Chicago Medical Center
Chicago, Illinois, 60637
Status
Recruiting
Address
Indiana University School of Medicine
Indianapolis, Indiana, 46202
Status
Recruiting
Address
The University of Iowa Hospitals and Clinics (University of Iowa Children's Hospital)
Iowa City, Iowa, 52242
Status
Terminated
Address
University of Kansas Medical Center
Kansas City, Kansas, 66160
Status
Recruiting
Address
University of Louisville Schoole of Medicine
Louisville, Kentucky, 40202
Status
Recruiting
Address
Tufts Medical Center
Boston, Massachusetts, 02111
Status
Recruiting
Address
Massachusetts General Hospital for Children
Boston, Massachusetts, 02114
Status
Recruiting
Address
Boston Children's Hospital
Boston, Massachusetts, 02115
Status
Terminated
Address
Bay State Medical Center
Springfield, Massachusetts, 01105
Status
Recruiting
Address
University of Michigan
Ann Arbor, Michigan, 48109
Status
Recruiting
Address
Helen Devos Children's Hospital
Grand Rapids, Michigan, 49503
Status
Terminated
Address
West Michigan Rheumatology
Grand Rapids, Michigan, 49546
Status
Recruiting
Address
University of Minnesota
Minneapolis, Minnesota, 55454
Status
Recruiting
Address
Mayo Clinic
Rochester, Minnesota, 55905
Status
Recruiting
Address
University of Mississippi Medical Center
Jackson, Mississippi, 39216
Status
Recruiting
Address
Children's Mercy Hospital
Kansas City, Missouri, 64108
Status
Recruiting
Address
Saint Louis University School of Medicine
Saint Louis, Missouri, 63104
Status
Recruiting
Address
Saint Louis Children's Hospital
Saint Louis, Missouri, 63110
Status
Recruiting
Address
Hackensack University Medical Center
Hackensack, New Jersey, 07601
Status
Recruiting
Address
Goryeb Children's Hospital
Morristown, New Jersey, 07960
Status
Recruiting
Address
Robert Wood Johnson Medical School
New Brunswick, New Jersey, 08901
Status
Recruiting
Address
The Pediatric Specialty Center at Saint Barnabas
West Orange, New Jersey, 07052
Status
Recruiting
Address
Albany Medical College
Albany, New York, 122089
Status
Recruiting
Address
Cohen Children's Medical Center of New York
Lake Success, New York, 11042
Status
Terminated
Address
New York University Langone Medical Center
New York, New York, 10016
Status
Recruiting
Address
Hospital for Special Surgery
New York, New York, 10021
Status
Recruiting
Address
Columbia University Medical Center
New York, New York, 10032
Status
Recruiting
Address
Children's Hospital at Montefiore
New York, New York, 10467
Status
Recruiting
Address
University of Rochester
Rochester, New York, 14642
Status
Recruiting
Address
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Status
Recruiting
Address
Levine Children's Hospital / Carolinas Medical Center
Charlotte, North Carolina, 28203
Status
Recruiting
Address
Duke Children's Hospital & Health Center
Durham, North Carolina, 27710
Status
Recruiting
Address
Wake Forest Baptist Brenner Children's Hospital
Winston-Salem, North Carolina, 27012
Status
Recruiting
Address
Sanford Health
Fargo, North Dakota, 58122
Status
Recruiting
Address
Akron Children's Hospital
Akron, Ohio, 44308
Status
Recruiting
Address
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229
Status
Terminated
Address
UH Rainbox Babies and Children's Hospital
Cleveland, Ohio, 44106
Status
Recruiting
Address
Metrohealth Medical Center
Cleveland, Ohio, 44109
Status
Recruiting
Address
Cleveland Clinic Foundation
Cleveland, Ohio, 44195
Status
Recruiting
Address
Nationwide Children's Hospital
Columbus, Ohio, 43205
Status
Recruiting
Address
Randall Children's Hospital at Legacy Emanuel
Portland, Oregon, 97227
Status
Recruiting
Address
Penn State Children's Hospital
Hershey, Pennsylvania, 17033
Status
Recruiting
Address
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Status
Recruiting
Address
Saint Christopher's Hospital for Children
Philadelphia, Pennsylvania, 19134
Status
Recruiting
Address
Children's Hospital of Pittsburgh UPMC
Pittsburgh, Pennsylvania, 15224
Status
Recruiting
Address
Hasbro Children's Hospital
Providence, Rhode Island, 02903
Status
Recruiting
Address
Medical University of South Carolina Children's Hospital
Charleston, South Carolina, 29425
Status
Recruiting
Address
Monroe Carrell Jr. Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232
Status
Recruiting
Address
University of Texas Southwestern Medical Center Dallas
Dallas, Texas, 75219
Status
Recruiting
Address
Baylor College of Medicine Pediatric Immunology Allergy Rheumatology
Houston, Texas, 77030
Status
Recruiting
Address
University of Utah Hospitals and Clinics (Primary Children's Hospital)
Salt Lake City, Utah, 84113
Status
Recruiting
Address
University of Vermont Medical Center
Burlington, Vermont, 05401
Status
Recruiting
Address
Children's Hospital of the King's Daughters
Norfolk, Virginia, 23507
Status
Recruiting
Address
Seattle Children's Hospital
Seattle, Washington, 98105
Status
Recruiting
Address
University of Wisconsin, American Family Children's Hospital
Madison, Wisconsin, 53792
Status
Recruiting
Address
Children's Hospital Of Wisconsin
Wauwatosa, Wisconsin, 53226
International Sites
Status
Recruiting
Address
University of Calgary - Alberta Children's Hospital
Calgary, Alberta, AB T38 6A8
Status
Recruiting
Address
University of Manitoba - Children's Hospital of Manitoba
Winnipeg, Manitoba, R3E 3P4
Status
Recruiting
Address
IWK Health Center
Halifax, Nova Scotia, NS B3K 6R8
Status
Recruiting
Address
The Hospital for Sick Children
Toronto, Ontario,
Status
Recruiting
Address
Schneider Children's Medical Center of Israel
Petach Tikva, , 49202-35
Status
Not yet recruiting
Address
IRCCS Ospedale Pediatrico Bambino Gesu (OPBG)
Rome, ,
Status
Withdrawn
Address
San Jorge Children's Hospital
San Juan, , 00912
