REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients

Study Overview
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Brief Summary
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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.

Official Title
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Registry of the Natural History of Recurrent Pericarditis in Pediatric and Adult Patients

Conditions
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Recurrent Pericarditis

Participation Criteria
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Eligibility Criteria
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ACTIVE RP PATIENTS Select Inclusion Criteria: Physician-confirmed (or confirmation in medical records) diagnosis of RP defined as an initial, acute, episode and at least one pericarditis recurrence after the initial acute episode Experienced at least one pericarditis episode in the 3 years prior to inclusion Under the care of a physician for the treatment and management of RP Currently prescribed medication for RP Select Exclusion Criteria: Diagnosis of pericarditis secondary to tuberculosis (TB), cancer if not in full remission, post thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis, systemic autoimmune diseases, except SJIA and adult Still's disease, HIV Appears to have an impairment (e.g., cognitive, hearing, visual) or insufficient English or Spanish proficiency that could interfere with ability to complete patient-completed assessments Currently enrolled in a therapeutic investigational drug or device study INACTIVE RP PATIENTS Select Inclusion Criteria: Physician-confirmed (or confirmation in medical records) diagnosis of RP defined as an initial, acute, episode and at least one pericarditis recurrence after the initial, acute episode Patient had a last episode occurring at least 3 years and up to 5 years before registry inclusion Resolution of RP symptoms confirmed with no further RP treatment for 3 years prior to registry enrollment Select Exclusion Criteria: Experienced a pericarditis episode within 3 years from enrolling in the registry Currently receiving RP treatment prescribed by a treating physician (e.g., CS, colchicine) Diagnosis of pericarditis secondary to tuberculosis (TB), cancer if not in full remission, post thoracic blunt trauma (e.g., motor-vehicle accidents), myocarditis, systemic autoimmune diseases except SJIA and adult Still's disease, HIV Enrolled in a therapeutic investigational clinical trial during the observation period

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active RP<br>Patients who are currently under the care of a physician for treatment of RP, currently on treatment for RP, and have had an episode (recurrence of typical pericarditis pain associated with supportive objective evidence of pericarditis) in the last 3 years prior to enrollment. Once included in the registry, these patients will have both retrospective and prospective follow-up and data collection (hybrid design). | |
| Inactive RP<br>Patients who have had a diagnosis of RP, have not had an episode for 3 years and have not been prescribed any treatment for RP in the last 3 years, prior to enrolling in the registry. Once included in the registry, data collected from these patients will be retrospective only. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients using 1 or more RP treatments | Proportion of patients using 1, 2, 3, or more concomitant RP treatments | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Most frequently used RP treatments | Number of subjects who used each treatment recorded during the study | 5 years | 
| Reduction in the use of corticosteroids | Change from baseline through end of observation in corticosteroid use | 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 | 1 year | 
| Change in pericardial rub | Change from baseline in pericardial rub | 5 years | 
| Change in pericardial effusion | Change from baseline in pericardial effusion | 5 years | 
| Change in fever | Change from baseline in fever | 5 years | 
| Change in dyspnea | Change from baseline in dyspnea | 5 years | 
| Change in C-reactive protein (CRP) | Change from baseline in CRP | 5 years | 
| Change in erythrocyte sedimentation rate (ESR) | Change from baseline in ESR | 5 years | 
| Change in white blood count (WBC) | Change from baseline in WBC | 5 years | 
| Change in interleukin-1 (IL-1) | Change from baseline in IL-1 | 5 years | 
| Change in interleukin-6 (IL-6) | Change from baseline in IL-6 | 5 years | 
| Change in electrocardiogram (ECG) | Change from baseline in ST-, PR-, QRS- and QT- intervals | 5 years | 
| Change in echocardiogram | Change from baseline in echocardiogram | 5 years | 
| Change in chest x-ray | Change from baseline in chest x-ray | 5 years | 
| Change in cardiac magnetic resonance imaging (cMRI) | Change from baseline in cMRI | 5 years | 
| Change in cardiovascular magnetic resonance (CMR) imaging | Change from baseline in CMR | 5 years | 
| Change in Multidetector (cardiac) computed tomography (MDCT) | Change from baseline in MDCT | 5 years | 
| Adverse event rate | Rate of adverse events reported by PC treatment | 5 years | 
| Changes in PROMIS-29 patient-reported outcomes | Change from baseline in PROMIS-29 | 5 years | 
| Changes in PROMIS Pediatric/Parent 25 patient-reported outcomes | Change from baseline in PROMIS Pediatric/Parent 25 | 5 years | 
| Changes in insomnia severity index (ISI) patient-reported outcomes | Change from baseline in ISI | 5 years | 
| Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes | Change from baseline in PGIPS | 5 years | 
| Changes in persistent pericarditis numerical rating scale (PPNRS) patient-reported outcomes | Change from baseline in PPNRS | 5 years | 
| Changes in D12 patient-reported outcomes | Change from baseline in D12 outcome measures | 5 years |