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Phase 3, Double-Blind, Placebo-Controlled, Randomized Withdrawal Study With Open-label Extension, to Assess the Efficacy and Safety of Rilonacept Treatment in Subjects With Recurrent Pericarditis
The primary objective of this study was to assess the efficacy of rilonacept treatment in participants with recurrent pericarditis.
In the single-blind run-in (RI) period, rilonacept 320 mg (or 4.4 mg/kg in pediatric participants ≥12 and \<18 years old) subcutaneous (SC), followed by 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and \<18 years old) injections once weekly. During the Randomized-Withdrawal (RW) period, eligible participants are randomized 1:1 to double-blinded administration of study drug: * Rilonacept 160 mg (or 2.2 mg/kg in pediatric participants ≥12 and \<18 years old) SC injections once weekly * Matching placebo SC injections once weekly. Participants with pericarditis recurrence who meet the protocol criteria for bailout rilonacept (report at least 1 day with pericarditis pain ≥4 on the 11-point numerical rating scale (NRS) and have 1 C-reactive protein (CRP) value ≥ 1 mg/dL \[either on the same day or separated by no more than 7 days\]) receive bailout rilonacept (2 open-label injections of 160 mg rilonacept \[or 4.4 mg/kg for pediatric subjects\]) irrespective of randomized treatment assignment and as soon as at least 5 days have passed since the last study drug injection. Upon completion of the RW period (i.e., when the prespecified number of primary efficacy endpoints \[clinical events committee-confirmed pericarditis recurrence\] events have occurred), all participants who did not discontinue study drug have an option to continue treatment with open-label rilonacept in the Long-Term Extension (LTE) or to withdraw from the study. Participants still in the RI period at the time that the RW period has ended and the LTE is opened will have the option to enter the LTE directly when they have completed the RI period and have met the definition of clinical response or to withdraw from the study.
Age
12 - No limit years
Sex
ALL
Healthy Volunteers
No
Cedars-Sinai Medical Institute
Los Angeles, California, United States
Arthritis and Rheumatology of Georgia
Atlanta, Georgia, United States
The Loretto Hospital
Chicago, Illinois, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic - PPDS
Rochester, Minnesota, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Cardiology Consultants of Philadelphia
Yardley, Pennsylvania, United States
Intermountain Healthcare
Murray, Utah, United States
University Of Vermont Medical Center
Burlington, Vermont, United States
Start Date
January 7, 2019
Primary Completion Date
May 29, 2020
Completion Date
June 30, 2022
Last Updated
September 6, 2023
86
ACTUAL participants
Rilonacept
DRUG
Placebo
DRUG
Lead Sponsor
Kiniksa Pharmaceuticals (UK), Ltd.
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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