title: Pilot study comparing the Childhood Arthritis & Rheumatology Research Alliance (CARRA) systemic Juvenile Idiopathic Arthritis Consensus Treatment Plans.
abstract: OBJECTIVE
  To assess the feasibility of studying the comparative effectiveness of the Childhood Arthritis and Rheumatology Research Alliance (CARRA) consensus treatment plans (CTPs) for systemic Juvenile Idiopathic Arthritis (JIA) using an observational registry.
  
  
  METHODS
  Untreated systemic JIA patients enrolled in the CARRA Registry were begun on one of 4 CTPs chosen by the treating physician and patient/family (glucocorticoid [GC] alone; methotrexate [MTX] ± GC; IL1 inhibitor [IL1i] ± GC; IL6 inhibitor [IL6i] ± GC). The primary outcome of clinical inactive disease (CID) without current GC use was assessed at 9 months.
  
  
  BACKGROUND
  clinicaltrials.gov NCT01697254; first registered 9/28/12 (retrospectively enrolled).
  
  
  RESULTS
  Thirty patients were enrolled at 13 sites; eight patients were started on a non-biologic CTP (2 GC, 6 MTX) and 22 patients on a biologic CTP (12 IL1i, 10 IL6i) at disease onset. Demographic and disease features were similar between CTP groups. CTP choice appeared to segregate by site preference. CID off GC was achieved by 37% (11 of 30) including 11/22 (50%) starting a biologic CTP compared to 0/8 starting a non-biologic CTP (p = 0.014). There were four serious adverse events: two infections, one appendicitis and one macrophage activation syndrome.
  
  
  CONCLUSIONS
  The CARRA systemic JIA CTP pilot study demonstrated successful implementation of CTPs using the CARRA registry infrastructure. Having demonstrated feasibility, a larger study using CTP response to better determine the relative effectiveness of treatments for new-onset systemic JIA is now underway.
authors.affiliation: Pediatric rheumatology, Joseph M. Sanzari Children's Hospital, Hackensack University Medical Center, 30 Prospect Ave, Hackensack, NJ, 07601, USA. Yukiko.Kimura@HackensackMeridian.org.
authors.forename: Yukiko
authors.identifier: http://orcid.org/0000-0001-7132-3390
authors.initials: Y
authors.lastname: Kimura
authors.affiliation: Pediatric rheumatology, Seattle Children's Hospital, Seattle, USA.
authors.forename: Sriharsha
authors.initials: S
authors.lastname: Grevich
authors.affiliation: Pediatric rheumatology, University of Alabama at Birmingham, Birmingham, USA.
authors.forename: Timothy
authors.initials: T
authors.lastname: Beukelman
authors.affiliation: Rheumatology, Cincinnati Children's Hospital Medical Center, Cincinnati, USA.
authors.forename: Esi
authors.initials: E
authors.lastname: Morgan
authors.affiliation: Rheumatology, Immunology and Allergy, Brigham and Women's Hospital, Boston, USA.
authors.forename: Peter A
authors.initials: PA
authors.lastname: Nigrovic
authors.affiliation: Childhood Arthritis & Rheumatology Research Alliance, Milwaukee, USA.
authors.forename: Kelly
authors.initials: K
authors.lastname: Mieszkalski
authors.affiliation: Pediatric rheumatology, Vanderbilt University, Nashville, USA.
authors.forename: T Brent
authors.initials: TB
authors.lastname: Graham
authors.affiliation: Pediatric rheumatology, Children's Mercy Hospital, Kansas City, USA.
authors.forename: Maria
authors.initials: M
authors.lastname: Ibarra
authors.affiliation: Pediatric rheumatology, Children's Hospital at Montefiore, Bronx, NY, USA.
authors.forename: Norman
authors.initials: N
authors.lastname: Ilowite
authors.affiliation: Pediatric rheumatology, Ann & Robert H. Lurie Children's Hospital of Chicago, Chicago, USA.
authors.forename: Marisa
authors.initials: M
authors.lastname: Klein-Gitelman
authors.affiliation: Pediatric rheumatology, University of Chicago, Chicago, USA.
authors.forename: Karen
authors.initials: K
authors.lastname: Onel
authors.affiliation: Pediatric rheumatology, Emory University School of Medicine, Atlanta, USA.
authors.forename: Sampath
authors.initials: S
authors.lastname: Prahalad
authors.affiliation: Pediatric rheumatology, Texas Scottish Rite Hospital, Dallas, USA.
authors.forename: Marilynn
authors.initials: M
authors.lastname: Punaro
authors.affiliation: Pediatric rheumatology, Seattle Children's Hospital, Seattle, USA.
authors.forename: Sarah
authors.initials: S
authors.lastname: Ringold
authors.affiliation: Pediatric rheumatology, St. Christopher's Hospital, Philadelphia, USA.
authors.forename: Dana
authors.initials: D
authors.lastname: Toib
authors.affiliation: Pediatric rheumatology, Duke University, Durham, NC, USA.
authors.forename: Heather
authors.initials: H
authors.lastname: Van Mater
authors.affiliation: Pediatric rheumatology, Joseph M. Sanzari Children's Hospital, Hackensack University Medical Center, 30 Prospect Ave, Hackensack, NJ, 07601, USA.
authors.forename: Jennifer E
authors.initials: JE
authors.lastname: Weiss
authors.affiliation: Pediatric rheumatology, Children's Hospital of Philadelphia, Philadelphia, USA.
authors.forename: Pamela F
authors.initials: PF
authors.lastname: Weiss
authors.affiliation: Pediatric rheumatology, Duke University, Durham, NC, USA.
authors.forename: Laura E
authors.initials: LE
authors.lastname: Schanberg
mesh_terms: D000293:Adolescent; D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized / Q000627:therapeutic use*; D018501:Antirheumatic Agents / Q000627:therapeutic use*; D001171:Arthritis, Juvenile / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D032921:Consensus; D004359:Drug Therapy, Combination; D005240:Feasibility Studies; D005260:Female; D005938:Glucocorticoids / Q000627:therapeutic use*; D006801:Humans; D053590:Interleukin 1 Receptor Antagonist Protein / Q000627:therapeutic use*; D008297:Male; D008727:Methotrexate / Q000627:therapeutic use*; D010865:Pilot Projects; D017410:Practice Guidelines as Topic; D011446:Prospective Studies; D012042:Registries; D012219:Rheumatology; D016896:Treatment Outcome
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018501:Antirheumatic Agents; D005938:Glucocorticoids; D053590:Interleukin 1 Receptor Antagonist Protein; C541220:canakinumab; C502936:tocilizumab; D008727:Methotrexate
keywords: Biologic response modifiers; Comparative effectiveness; Pediatric rheumatology; Registries; Still’s disease; Systemic Juvenile Idiopathic Arthritis