Study design
pericarditis
RECURRENCES, PERICARDITIS, PERICARDITIS
The study design and CONSORT diagram of RHAPSODY were reported previously.The run-in period was followed by a randomised-withdrawal period, during which eligible patients were randomised to receive continued rilonacept or placebo. Once the prespecified number of adjudicated pericarditis recurrences had accrued, the randomised-withdrawal phase was closed, and eligible patients had the option to continue open-label rilonacept during a long-term extension.The goal of the run-in period was to prepare patients for randomisation to rilonacept or placebo at week 12. To accomplish this and to ensure clinical stability on rilonacept monotherapy at randomisation, attainment of rilonacept monotherapy was required by week 10. The run-in period included a 1-week stabilisation period of rilonacept administration with standard oral therapies (NSAIDs, colchicine, glucocorticoids), a 9-week phase of transition off oral therapies with continued rilonacept treatment, and 2 weeks of rilonacept monotherapy (Proposed medication tapering scheduleNSAIDs, non-steroidal anti-inflammatory drugs.Study design of Rilonacept inHibition of interleukin-1 Alpha and beta for recurrent Pericarditis: a pivotal Symptomatology and Outcomes study (RHAPSODY) run-in period. NSAID, non-steroidal anti-inflammatory drug; SC, subcutaneous.