The registry will focus on furthering the understanding of the natural history of recurrent pericarditis (RP), as well as document RP-related clinical, health-related quality of life (HRQoL), and economic burden and will assist the medical community to refine or develop data-driven recommendations for clinical management of RP patients to optimize clinical outcomes. It also aims to generate data in support of the impact of rilonacept on clinical outcomes in a real-world population.
Study Type
OBSERVATIONAL
Enrollment
500
Patients using 1 or more RP treatments
Proportion of patients using 1, 2, 3, or more concomitant RP treatments
Time frame: 5 years
Most frequently used RP treatments
Number of subjects who used each treatment recorded during the study
Time frame: 5 years
Reduction in the use of corticosteroids
Change from baseline through end of observation in corticosteroid use
Time frame: 5 years
Change in RP activity
Change from baseline in RP disease recurrences within 1 year (from 1 year prior to baseline to 1 year after baseline
Time frame: 1 year
Change in pericardial rub
Change from baseline in pericardial rub
Time frame: 5 years
Change in pericardial effusion
Change from baseline in pericardial effusion
Time frame: 5 years
Change in fever
Change from baseline in fever
Time frame: 5 years
Change in dyspnea
Change from baseline in dyspnea
Time frame: 5 years
Change in C-reactive protein (CRP)
Change from baseline in CRP
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Alaska Heart & Vascular Institute
Anchorage, Alaska, United States
Pima Heart and Vascular
Tucson, Arizona, United States
University of California San Diego Medical Center
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Scripps Health
San Diego, California, United States
Northwestern University
Chicago, Illinois, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
...and 19 more locations
Time frame: 5 years
Change in erythrocyte sedimentation rate (ESR)
Change from baseline in ESR
Time frame: 5 years
Change in white blood count (WBC)
Change from baseline in WBC
Time frame: 5 years
Change in interleukin-1 (IL-1)
Change from baseline in IL-1
Time frame: 5 years
Change in interleukin-6 (IL-6)
Change from baseline in IL-6
Time frame: 5 years
Change in electrocardiogram (ECG)
Change from baseline in ST-, PR-, QRS- and QT- intervals
Time frame: 5 years
Change in echocardiogram
Change from baseline in echocardiogram
Time frame: 5 years
Change in chest x-ray
Change from baseline in chest x-ray
Time frame: 5 years
Change in cardiac magnetic resonance imaging (cMRI)
Change from baseline in cMRI
Time frame: 5 years
Change in cardiovascular magnetic resonance (CMR) imaging
Change from baseline in CMR
Time frame: 5 years
Change in Multidetector (cardiac) computed tomography (MDCT)
Change from baseline in MDCT
Time frame: 5 years
Adverse event rate
Rate of adverse events reported by PC treatment
Time frame: 5 years
Changes in PROMIS-29 patient-reported outcomes
Change from baseline in PROMIS-29
Time frame: 5 years
Changes in PROMIS Pediatric/Parent 25 patient-reported outcomes
Change from baseline in PROMIS Pediatric/Parent 25
Time frame: 5 years
Changes in insomnia severity index (ISI) patient-reported outcomes
Change from baseline in ISI
Time frame: 5 years
Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes
Change from baseline in PGIPS
Time frame: 5 years
Changes in persistent pericarditis numerical rating scale (PPNRS) patient-reported outcomes
Change from baseline in PPNRS
Time frame: 5 years
Changes in D12 patient-reported outcomes
Change from baseline in D12 outcome measures
Time frame: 5 years