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Abstract Number: 981

New Consensus on an Updated Core Domain Set for Clinical Trials in Juvenile Idiopathic Arthritis

Esi Morgan1, Alessandro Consolaro2, Jane Munro3, Jennifer Horonjeff4, Brian M. Feldman5, Hayyah Clairman6, Clifton O. Bingham III7, Alessandra Alongi8, Vibeke Strand9, Marion A.J. van Rossum10, Richard Veselý11, Hermine I. Brunner12, Daniel Horton13, Daniel J Lovell14, Sarah Ringold15, Nicola Ruperto16, Suzanne Schrandt17, Natalie Jane Shiff18, Karine Toupin-April19 and Beverly Shea20, 1University of Cincinnati, Cincinnati, OH, 2Clinica Pediatrica - Reumatologia, Istituto Giannina Gaslini, Genova, Italy, 3Paediatric Rheumatology, Royal Children's Hospital, Victoria, Australia, 4Columbia University Medical Centre, New York, NY, 5Rheumatology, The Hospital for Sick Children, Toronto, ON, Canada, 6Child Health Evaluative Sciences, Hospital for Sick Children, Toronto, ON, Canada, 7Rheumatology, Johns Hopkins University School of Medicine, Baltimore, MD, 8University of Genova, Genova, Italy, 9Stanford University, Palo Alto, CA, 10Amsterdam Rheumatology and Immunology Center / Reade, Emma Children’s Hospital Amsterdam Medical Center, Amsterdam, Netherlands, 11Scientific and Regulatory Management Department, European Medicines Agency, London, United Kingdom, 12Pediatric Rheumatology Collaborative Study Group (PRCSG), Cincinnati Children’s Hospital Medical Center, Cincinnati, OH, 13Rutgers Robert Wood Johnson Medical School, New Brunswick, NJ, 14Cincinnati Children's Hospital Medical Center, Cincinnati, OH, 15Pediatric Rheumatology, Seattle Children's Hospital, Seattle, WA, 16Universita di Genova Pediatria II, Genova, Italy, 17Arthritis Foundation, Saint Paul, MN, 18Pediatrics, University of Florida, Gainesville, FL, 19Children’s Hospital of Eastern Ontario Research Institute, Ottawa, ON, Canada, 20Bruyere Research Institute, Ottawa, ON, Canada

Meeting: 2018 ACR/ARHP Annual Meeting

Keywords: clinical trials, juvenile idiopathic arthritis-enthesitis (ERA) and outcome measures

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Session Information

Date: Sunday, October 21, 2018

Session Title: 3S115 ACR/ARHP Abstract: Pediatric Rheum (976–981)

Session Type: ACR/ARHP Combined Abstract Session

Session Time: 4:30PM-6:00PM

Background/Purpose: The current JIA Core Set (ACR Pediatric 30) to assess efficacy of medications in randomized controlled trials (RCTs) was published in 1997 and developed without input from patients or caregivers. The current core set includes 6 variables: physician global assessment, parent/patient global assessment of overall wellbeing, physical functional ability, count of joints with active arthritis, count of joints with restricted motion, an acute phase reactant and – for systemic JIA – fever in past week. Outcome Measures in Rheumatology (OMERACT) recommends four core areas to include in RCTs and longitudinal observational studies (LOS) – 1) life impact, 2) pathophysiologic manifestations, 3) resource use, 4) adverse events – and conceptualizes domains along three levels of requirements for inclusion: inner circle – mandatory for all RCTs and LOS; middle circle – important, but optional; outer circle – research agenda. Since 2015, the OMERACT JIA Core Set working group has obtained global stakeholder input from JIA patients, caregivers, health care providers and researchers to update the JIA core domain set. At the OMERACT 2016 meeting, a special interest group voted to reconsider the entire core set. This abstract reports subsequent work.

Methods: Online discussion boards (ODBs) were held with JIA patients and parents in Australia and Italy, and results compared to USA ODBs to generate candidate domains. Three rounds of a Delphi process to prioritize these domains were held with stakeholders identified by patient advocacy groups, pediatric rheumatology clinical trials organizations and regulators. In the final Delphi round, domains were rated for inclusion in inner, middle or outer circles. Results were presented at the OMERACT conference in May 2018 for consensus among participants, with level of consensus set at ≥70%.

Results: 53 JIA patients (ages 15-24) and 55 parents participated in ODBs. Three rounds of Delphi considering 27 domains were completed by 196 (response rate 80%), 201 (81%) and 182 (77%) stakeholders, respectively, from 42 countries. Result of the final voting at the OMERACT 2018 conference approved the following core domains for JIA RCTs and LOS with 83% endorsement. Inner circle: pain, activity limitation/physical function, joint inflammatory signs (active joints), patient global assessment, adverse events. Middle circle: extra-articular inflammation (including uveitis), joint damage, labs, physician global assessment, stiffness, growth/maturation, participation restriction, imaging signs of inflammation, fatigue, impact on emotional function/mood/cognition, physical activity. Outer circle: coping with illness, healthcare utilization, sleep, social relationships, personal factors.

Conclusion: We have developed an updated JIA Core Domain Set following OMERACT methodology with qualitative input from patients/parents and broad stakeholders through a Delphi process and consensus voting. A notable change is pain is now recommended as a core domain for all JIA RCTs, LOS. Multiple patient reported domains were also voted as important to consider for inclusion in JIA trials, including fatigue, emotional function, and participation restriction.


Disclosure: E. Morgan, None; A. Consolaro, None; J. Munro, None; J. Horonjeff, None; B. M. Feldman, None; H. Clairman, None; C. O. Bingham III, None; A. Alongi, None; V. Strand, AbbVie, Amgen, AstraZeneca, BMS, Boehringer Ingelheim, Celltrion, EMD Serono, Genentech/Roche, GSK, Janssen, Lilly, Novartis, Pfizer, Regeneron, Sanofi, and UCB, 5; M. A. J. van Rossum, None; R. Veselý, None; H. I. Brunner, None; D. Horton, None; D. J. Lovell, AstraZeneca, Amgen, Abbott, Pfizer, 5,Wyeth, 8; S. Ringold, None; N. Ruperto, full-time employee of the GASLINI Hospital, which has received contributions to support the research activities of the network of PRINTO from AbbVie Inc., AstraZeneca, Bristol-Myers Squibb, Janssen Biologics B.V., Eli Lilly and Co., “Francesco Angelini”,, 9,Astellas, AstraZeneca, Bristol-Myers Squibb, Italfarmaco, Janssen Biologics B.V., MedImmune, Roche, and Wyeth/Pfizer, 8; S. Schrandt, None; N. J. Shiff, None; K. Toupin-April, None; B. Shea, None.

To cite this abstract in AMA style:

Morgan E, Consolaro A, Munro J, Horonjeff J, Feldman BM, Clairman H, Bingham III CO, Alongi A, Strand V, van Rossum MAJ, Veselý R, Brunner HI, Horton D, Lovell DJ, Ringold S, Ruperto N, Schrandt S, Shiff NJ, Toupin-April K, Shea B. New Consensus on an Updated Core Domain Set for Clinical Trials in Juvenile Idiopathic Arthritis [abstract]. Arthritis Rheumatol. 2018; 70 (suppl 9). https://acrabstracts.org/abstract/new-consensus-on-an-updated-core-domain-set-for-clinical-trials-in-juvenile-idiopathic-arthritis/. Accessed January 27, 2023.
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