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

Timothy Beukelman, Yukiko Kimura, Norman T. Ilowite, Kelly Mieszkalski, Marc D. Natter, Grendel Burrell, Brian Best, Jason Jones, Laura E. Schanberg, Leslie Abramson, Shoghik Akoghlanian, Edwin Anderson, Margaret Andrew, Kevin Baszis, Mara Becker, Heather Bell-Brunson, Heather Benham, James Birmingham, Peter Blier, Hermine BrunnerElizabeth Chalom, Johanna Chang, Paula Charpentier, Nazma Chowdhury, Joni Dean, Fatma Dedeoglu, Marija Dionizovik-Dimanovski, Brian Feldman, Polly Ferguson, Marie Fox, Kimberly Francis, Lourdes Franco, Mary Gervasini, Ingrid Goh, Donald Goldsmith, T. Brent Graham, Thomas Griffin, Dawn Helfrich, Kristin Hickey, Mark Hoeltzel, Sarah Holtschlag, Joyce Hsu, Adam Huber, Anna Huttenlocher, Lisa Imundo, Christi Inman, Jane Jaquith, Rita Jerath, Suzy Jones, Marilynn Punaro, For the CARRA Registry Investigators

Research output: Contribution to journalArticle

18 Scopus citations

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

ASJC Scopus subject areas

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

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    Beukelman, T., Kimura, Y., Ilowite, N. T., Mieszkalski, K., Natter, M. D., Burrell, G., Best, B., Jones, J., Schanberg, L. E., Abramson, L., Akoghlanian, S., Anderson, E., Andrew, M., Baszis, K., Becker, M., Bell-Brunson, H., Benham, H., Birmingham, J., Blier, P., ... For the CARRA Registry Investigators (2017). The new Childhood Arthritis and Rheumatology Research Alliance (CARRA) registry: Design, rationale, and characteristics of patients enrolled in the first 12months. Pediatric Rheumatology, 15(1), [30]. https://doi.org/10.1186/s12969-017-0160-6