Background: The management of background corticosteroid therapy in rheumatology clinical trials poses a major challenge. We describe the consensus methodology used to design an algorithm to standardize changes in corticosteroid dosing during the Randomized Placebo Phase Study of Rilonacept in Systemic Juvenile Idiopathic Arthritis Trial (RAPPORT).Methods: The 20 RAPPORT site principal investigators (PIs) and 4 topic specialists constituted an expert panel that participated in the consensus process. The panel used a modified Delphi Method consisting of an on-line questionnaire, followed by a one day face-to-face consensus conference. Consensus was defined as ≥ 75% agreement. For items deemed essential but when consensus on critical values was not achieved, simple majority vote drove the final decision.Results: The panel identified criteria for initiating or increasing corticosteroids. These included the presence or development of anemia, myocarditis, pericarditis, pleuritis, peritonitis, and either complete or incomplete macrophage activation syndrome (MAS). The panel also identified criteria for tapering corticosteroids which included absence of fever for ≥ 3 days in the previous week, absence of poor physical functioning, and seven laboratory criteria. A tapering schedule was also defined.Conclusion: The expert panel established consensus regarding corticosteroid management and an algorithm for steroid dosing that was well accepted and used by RAPPORT investigators. Developed specifically for the RAPPORT trial, further study of the algorithm is needed before recommendation for more general clinical use.
Bibliographical noteFunding Information:
Supported by a grant from the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NO1 AR 700015) (ClinicalTrials.gov identifier NCT00534495) and by the Arthritis Foundation. B Feldman declares that he is on the Data Safety and Monitoring Boards for drugs from Novartis, Pfizer, and Bristol Myers Squibb, and has research support from Baxter Labs and Bayer.
standardize changes in corticosteroid dosing during the study. RAPPORT is a study of the efficacy and short-term safety of the IL-1 inhibitor rilonacept in systemic JIA (SJIA), which utilized 20 sites from the Childhood Arthritis and Rheumatology Research Alliance (CARRA), and was funded by the National Institute of Arthritis, Musculoskeletal and Skin Diseases (NO1 AR 700015).