REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients
- Conditions
- Recurrent Pericarditis
- Registration Number
- NCT04687358
- Lead Sponsor
- Kiniksa Pharmaceuticals International, plc
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 500
- 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
- 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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Patients using 1 or more RP treatments 5 years Proportion of patients using 1, 2, 3, or more concomitant RP treatments
- Secondary Outcome Measures
Name Time Method Adverse event rate 5 years Rate of adverse events reported by PC treatment
Change in cardiac magnetic resonance imaging (cMRI) 5 years Change from baseline in cMRI
Change in echocardiogram 5 years Change from baseline in echocardiogram
Change in fever 5 years Change from baseline in fever
Change in Multidetector (cardiac) computed tomography (MDCT) 5 years Change from baseline in MDCT
Change in C-reactive protein (CRP) 5 years Change from baseline in CRP
Change in interleukin-1 (IL-1) 5 years Change from baseline in IL-1
Change in chest x-ray 5 years Change from baseline in chest x-ray
Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes 5 years Change from baseline in PGIPS
Change in dyspnea 5 years Change from baseline in dyspnea
Change in interleukin-6 (IL-6) 5 years Change from baseline in IL-6
Change in cardiovascular magnetic resonance (CMR) imaging 5 years Change from baseline in CMR
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
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 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 electrocardiogram (ECG) 5 years Change from baseline in ST-, PR-, QRS- and QT- intervals
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
Trial Locations
- Locations (29)
Houston Methodist Hospital
🇺🇸Houston, Texas, United States
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
Detroit Medical Center
🇺🇸Detroit, Michigan, United States
Minneapolis Heart Institute Foundation
🇺🇸Minneapolis, Minnesota, United States
Mayo Clinic - PPDS
🇺🇸Rochester, Minnesota, United States
Barnes-Jewish Hospital/Washington University
🇺🇸Saint Louis, Missouri, United States
University of Nebraska
🇺🇸Omaha, Nebraska, United States
TKL Research Inc.
🇺🇸Fair Lawn, New Jersey, United States
NYU Langone Health
🇺🇸New York, New York, United States
Northwell Health - Lenox Hill Hospital
🇺🇸New York, New York, United States
The Linder Research Center at The Christ Hospital
🇺🇸Cincinnati, Ohio, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Legacy Medical Group, Cardiology
🇺🇸Portland, Oregon, United States
Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital
🇺🇸Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
🇺🇸Dallas, Texas, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
University of Vermont Medical Center
🇺🇸Burlington, Vermont, United States
Virginia Commonwealth University
🇺🇸Richmond, Virginia, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
Swedish Medical Center - Cherry Hill
🇺🇸Seattle, Washington, United States