Recurrent Pericarditis
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Kiniksa Pharmaceuticals International, plc
Kiniksa Pharmaceuticals (UK), Ltd.
Study design
Observational model
COHORT
Time perspective
OTHER
Eligibility
Sex/Gender
ALL
Age
7 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patients using 1 or more RP treatments | 5 years | Proportion of patients using 1, 2, 3, or more concomitant RP treatments |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Most frequently used RP treatments | 5 years | Number of subjects who used each treatment recorded during the study |
| Reduction in the use of corticosteroids | 5 years | Change from baseline through end of observation in corticosteroid use |
| Change in RP activity | 1 year | Change from baseline in RP disease recurrences within 1 year (from 1 year prior to baseline to 1 year after baseline |
| Change in pericardial rub | 5 years | Change from baseline in pericardial rub |
| Change in pericardial effusion | 5 years | Change from baseline in pericardial effusion |
| Change in fever | 5 years | Change from baseline in fever |
| Change in dyspnea | 5 years | Change from baseline in dyspnea |
| Change in C-reactive protein (CRP) | 5 years | Change from baseline in CRP |
| Change in erythrocyte sedimentation rate (ESR) | 5 years | Change from baseline in ESR |
| Change in white blood count (WBC) | 5 years | Change from baseline in WBC |
| Change in interleukin-1 (IL-1) | 5 years | Change from baseline in IL-1 |
| Change in interleukin-6 (IL-6) | 5 years | Change from baseline in IL-6 |
| Change in electrocardiogram (ECG) | 5 years | Change from baseline in ST-, PR-, QRS- and QT- intervals |
| Change in echocardiogram | 5 years | Change from baseline in echocardiogram |
| Change in chest x-ray | 5 years | Change from baseline in chest x-ray |
| Change in cardiac magnetic resonance imaging (cMRI) | 5 years | Change from baseline in cMRI |
| Change in cardiovascular magnetic resonance (CMR) imaging | 5 years | Change from baseline in CMR |
| Change in Multidetector (cardiac) computed tomography (MDCT) | 5 years | Change from baseline in MDCT |
| Adverse event rate | 5 years | Rate of adverse events reported by PC treatment |
| Changes in PROMIS-29 patient-reported outcomes | 5 years | Change from baseline in PROMIS-29 |
| Changes in PROMIS Pediatric/Parent 25 patient-reported outcomes | 5 years | Change from baseline in PROMIS Pediatric/Parent 25 |
| Changes in insomnia severity index (ISI) patient-reported outcomes | 5 years | Change from baseline in ISI |
| Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes | 5 years | Change from baseline in PGIPS |
| Changes in persistent pericarditis numerical rating scale (PPNRS) patient-reported outcomes | 5 years | Change from baseline in PPNRS |
| Changes in D12 patient-reported outcomes | 5 years | Change from baseline in D12 outcome measures |
Countries
United States
Contacts
STUDY_DIRECTORJohn F Paolini, MD, PhD
Kiniksa Pharmaceuticals Corp
Outcome results
None listed