The new Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry

Design, rationale, and characteristics of patients enrolled in the first 12months

For the CARRA Registry Investigators

Research output: Contribution to journalArticle

13 Citations (Scopus)

Abstract

Background: Herein we describe the history, design, and rationale of the new Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry and present the characteristics of patients with juvenile idiopathic arthritis (JIA) enrolled in the first 12months of operation. Methods: The CARRA Registry began prospectively collecting data in the United States and Canada in July 2015 to evaluate the safety of therapeutic agents in persons with childhood-onset rheumatic disease, initially restricted to JIA. Secondary objectives include the evaluation of disease outcomes and their associations with medication use and other factors. Data are collected every 6months and include clinical assessments, detailed medication use, patient-reported outcomes, and safety events. Follow-up is planned for at least 10years for each participant and is facilitated by a telephone call center. Results: As of July 2016, 1192 patients with JIA were enrolled in the CARRA Registry at 49 clinical sites. At enrollment, their median age was 12.4years old and median disease duration was 2.6years. Owing to preferential enrollment, patients with systemic JIA (13%) and with a polyarticular course (75%) were over-represented compared to patients in typical clinical practice. Approximately 49% were currently using biologic agents and ever use of oral glucocorticoids was common (47%). The CARRA Registry provides safety surveillance data to pharmaceutical companies to satisfy their regulatory requirements, and several independently-funded sub-studies that use the Registry infrastructure are underway. Conclusion: The new CARRA Registry successfully enrolled nearly 1200 participants with JIA in the first 12months of its operation. Sustainable funding has been secured from multiple sources. The CARRA Registry may serve as a model for the study of other uncommon diseases.

Original languageEnglish (US)
Article number30
JournalPediatric Rheumatology
Volume15
Issue number1
DOIs
StatePublished - Apr 17 2017

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Rheumatology
Arthritis
Registries
Juvenile Arthritis
Research
Safety
Biological Factors
Rheumatic Diseases
Telephone
Glucocorticoids
Canada
History
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Pediatrics, Perinatology, and Child Health
  • Immunology and Allergy
  • Rheumatology

Cite this

The new Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry : Design, rationale, and characteristics of patients enrolled in the first 12months. / For the CARRA Registry Investigators.

In: Pediatric Rheumatology, Vol. 15, No. 1, 30, 17.04.2017.

Research output: Contribution to journalArticle

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title = "The new Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry: Design, rationale, and characteristics of patients enrolled in the first 12months",
abstract = "Background: Herein we describe the history, design, and rationale of the new Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry and present the characteristics of patients with juvenile idiopathic arthritis (JIA) enrolled in the first 12months of operation. Methods: The CARRA Registry began prospectively collecting data in the United States and Canada in July 2015 to evaluate the safety of therapeutic agents in persons with childhood-onset rheumatic disease, initially restricted to JIA. Secondary objectives include the evaluation of disease outcomes and their associations with medication use and other factors. Data are collected every 6months and include clinical assessments, detailed medication use, patient-reported outcomes, and safety events. Follow-up is planned for at least 10years for each participant and is facilitated by a telephone call center. Results: As of July 2016, 1192 patients with JIA were enrolled in the CARRA Registry at 49 clinical sites. At enrollment, their median age was 12.4years old and median disease duration was 2.6years. Owing to preferential enrollment, patients with systemic JIA (13{\%}) and with a polyarticular course (75{\%}) were over-represented compared to patients in typical clinical practice. Approximately 49{\%} were currently using biologic agents and ever use of oral glucocorticoids was common (47{\%}). The CARRA Registry provides safety surveillance data to pharmaceutical companies to satisfy their regulatory requirements, and several independently-funded sub-studies that use the Registry infrastructure are underway. Conclusion: The new CARRA Registry successfully enrolled nearly 1200 participants with JIA in the first 12months of its operation. Sustainable funding has been secured from multiple sources. The CARRA Registry may serve as a model for the study of other uncommon diseases.",
author = "{For the CARRA Registry Investigators} and Timothy Beukelman and Yukiko Kimura and Ilowite, {Norman Todd} and Kelly Mieszkalski and Natter, {Marc D.} and Grendel Burrell and Brian Best and Jason Jones and Schanberg, {Laura E.} and Leslie Abramson and Shoghik Akoghlanian and Edwin Anderson and Margaret Andrew and Kevin Baszis and Mara Becker and Heather Bell-Brunson and Heather Benham and James Birmingham and Peter Blier and Hermine Brunner and Elizabeth Chalom and Johanna Chang and Paula Charpentier and Nazma Chowdhury and Joni Dean and Fatma Dedeoglu and Marija Dionizovik-Dimanovski and Brian Feldman and Polly Ferguson and Marie Fox and Kimberly Francis and Lourdes Franco and Mary Gervasini and Ingrid Goh and Donald Goldsmith and {Brent Graham}, T. and Thomas Griffin and Dawn Helfrich and Kristin Hickey and Mark Hoeltzel and Sarah Holtschlag and Joyce Hsu and Adam Huber and Anna Huttenlocher and Lisa Imundo and Christi Inman and Jane Jaquith and Rita Jerath and Suzy Jones and Philip Kahn",
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AU - Beukelman, Timothy

AU - Kimura, Yukiko

AU - Ilowite, Norman Todd

AU - Mieszkalski, Kelly

AU - Natter, Marc D.

AU - Burrell, Grendel

AU - Best, Brian

AU - Jones, Jason

AU - Schanberg, Laura E.

AU - Abramson, Leslie

AU - Akoghlanian, Shoghik

AU - Anderson, Edwin

AU - Andrew, Margaret

AU - Baszis, Kevin

AU - Becker, Mara

AU - Bell-Brunson, Heather

AU - Benham, Heather

AU - Birmingham, James

AU - Blier, Peter

AU - Brunner, Hermine

AU - Chalom, Elizabeth

AU - Chang, Johanna

AU - Charpentier, Paula

AU - Chowdhury, Nazma

AU - Dean, Joni

AU - Dedeoglu, Fatma

AU - Dionizovik-Dimanovski, Marija

AU - Feldman, Brian

AU - Ferguson, Polly

AU - Fox, Marie

AU - Francis, Kimberly

AU - Franco, Lourdes

AU - Gervasini, Mary

AU - Goh, Ingrid

AU - Goldsmith, Donald

AU - Brent Graham, T.

AU - Griffin, Thomas

AU - Helfrich, Dawn

AU - Hickey, Kristin

AU - Hoeltzel, Mark

AU - Holtschlag, Sarah

AU - Hsu, Joyce

AU - Huber, Adam

AU - Huttenlocher, Anna

AU - Imundo, Lisa

AU - Inman, Christi

AU - Jaquith, Jane

AU - Jerath, Rita

AU - Jones, Suzy

AU - Kahn, Philip

PY - 2017/4/17

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N2 - Background: Herein we describe the history, design, and rationale of the new Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry and present the characteristics of patients with juvenile idiopathic arthritis (JIA) enrolled in the first 12months of operation. Methods: The CARRA Registry began prospectively collecting data in the United States and Canada in July 2015 to evaluate the safety of therapeutic agents in persons with childhood-onset rheumatic disease, initially restricted to JIA. Secondary objectives include the evaluation of disease outcomes and their associations with medication use and other factors. Data are collected every 6months and include clinical assessments, detailed medication use, patient-reported outcomes, and safety events. Follow-up is planned for at least 10years for each participant and is facilitated by a telephone call center. Results: As of July 2016, 1192 patients with JIA were enrolled in the CARRA Registry at 49 clinical sites. At enrollment, their median age was 12.4years old and median disease duration was 2.6years. Owing to preferential enrollment, patients with systemic JIA (13%) and with a polyarticular course (75%) were over-represented compared to patients in typical clinical practice. Approximately 49% were currently using biologic agents and ever use of oral glucocorticoids was common (47%). The CARRA Registry provides safety surveillance data to pharmaceutical companies to satisfy their regulatory requirements, and several independently-funded sub-studies that use the Registry infrastructure are underway. Conclusion: The new CARRA Registry successfully enrolled nearly 1200 participants with JIA in the first 12months of its operation. Sustainable funding has been secured from multiple sources. The CARRA Registry may serve as a model for the study of other uncommon diseases.

AB - Background: Herein we describe the history, design, and rationale of the new Childhood Arthritis and Rheumatology Research Alliance (CARRA) Registry and present the characteristics of patients with juvenile idiopathic arthritis (JIA) enrolled in the first 12months of operation. Methods: The CARRA Registry began prospectively collecting data in the United States and Canada in July 2015 to evaluate the safety of therapeutic agents in persons with childhood-onset rheumatic disease, initially restricted to JIA. Secondary objectives include the evaluation of disease outcomes and their associations with medication use and other factors. Data are collected every 6months and include clinical assessments, detailed medication use, patient-reported outcomes, and safety events. Follow-up is planned for at least 10years for each participant and is facilitated by a telephone call center. Results: As of July 2016, 1192 patients with JIA were enrolled in the CARRA Registry at 49 clinical sites. At enrollment, their median age was 12.4years old and median disease duration was 2.6years. Owing to preferential enrollment, patients with systemic JIA (13%) and with a polyarticular course (75%) were over-represented compared to patients in typical clinical practice. Approximately 49% were currently using biologic agents and ever use of oral glucocorticoids was common (47%). The CARRA Registry provides safety surveillance data to pharmaceutical companies to satisfy their regulatory requirements, and several independently-funded sub-studies that use the Registry infrastructure are underway. Conclusion: The new CARRA Registry successfully enrolled nearly 1200 participants with JIA in the first 12months of its operation. Sustainable funding has been secured from multiple sources. The CARRA Registry may serve as a model for the study of other uncommon diseases.

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U2 - 10.1186/s12969-017-0160-6

DO - 10.1186/s12969-017-0160-6

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JO - Pediatric Rheumatology

JF - Pediatric Rheumatology

SN - 1546-0096

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