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

Recurrent Pericarditis Clinical Trial

— RESONANCE  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04687358
• Other study ID #: KPL-914-Reg-001
• Status: Recruiting
• Start date: March 16, 2021
• Est. completion date: February 2026

Study information

• Verified date: April 2024
• Source: Kiniksa Pharmaceuticals, Ltd.
• Contact: JoAnn Clair, PhD
• Phone: 781-431-9100
• Email: jclair[@]kiniksa.com
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. completion date: February 2026
• Est. primary completion date: February 2026
• Gender: All
• Age group: 7 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pericarditis
• Recurrence
• Recurrent Pericarditis

Locations

Country	Name	City	State
United States	Alaska Heart & Vascular Institute	Anchorage	Alaska
United States	Johns Hopkins University	Baltimore	Maryland
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	University of Vermont Medical Center	Burlington	Vermont
United States	Northwestern University	Chicago	Illinois
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio
United States	The Linder Research Center at The Christ Hospital	Cincinnati	Ohio
United States	Cleveland Clinic	Cleveland	Ohio
United States	University of Texas Southwestern Medical Center	Dallas	Texas
United States	Midwest Cardiovascular Research Foundation	Davenport	Iowa
United States	Detroit Medical Center	Detroit	Michigan
United States	TKL Research Inc.	Fair Lawn	New Jersey
United States	Houston Methodist Hospital	Houston	Texas
United States	University of California San Diego Medical Center	La Jolla	California
United States	Cedars Sinai Medical Center	Los Angeles	California
United States	Cedars-Sinai Medical Center	Los Angeles	California
United States	Minneapolis Heart Institute Foundation	Minneapolis	Minnesota
United States	Northwell Health - Lenox Hill Hospital	New York	New York
United States	NYU Langone Health	New York	New York
United States	University of Nebraska	Omaha	Nebraska
United States	Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital	Pittsburgh	Pennsylvania
United States	Legacy Medical Group, Cardiology	Portland	Oregon
United States	Virginia Commonwealth University	Richmond	Virginia
United States	Mayo Clinic - PPDS	Rochester	Minnesota
United States	Barnes-Jewish Hospital/Washington University	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	Scripps Health	San Diego	California
United States	Seattle Children's Hospital	Seattle	Washington
United States	Swedish Medical Center - Cherry Hill	Seattle	Washington
United States	Pima Heart and Vascular	Tucson	Arizona
United States	Children's National Hospital	Washington	District of Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Kiniksa Pharmaceuticals (UK), Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patients using 1 or more RP treatments	Proportion of patients using 1, 2, 3, or more concomitant RP treatments	5 years
Secondary	Most frequently used RP treatments	Number of subjects who used each treatment recorded during the study	5 years
Secondary	Reduction in the use of corticosteroids	Change from baseline through end of observation in corticosteroid use	5 years
Secondary	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
Secondary	Change in pericardial rub	Change from baseline in pericardial rub	5 years
Secondary	Change in pericardial effusion	Change from baseline in pericardial effusion	5 years
Secondary	Change in fever	Change from baseline in fever	5 years
Secondary	Change in dyspnea	Change from baseline in dyspnea	5 years
Secondary	Change in C-reactive protein (CRP)	Change from baseline in CRP	5 years
Secondary	Change in erythrocyte sedimentation rate (ESR)	Change from baseline in ESR	5 years
Secondary	Change in white blood count (WBC)	Change from baseline in WBC	5 years
Secondary	Change in interleukin-1 (IL-1)	Change from baseline in IL-1	5 years
Secondary	Change in interleukin-6 (IL-6)	Change from baseline in IL-6	5 years
Secondary	Change in electrocardiogram (ECG)	Change from baseline in ST-, PR-, QRS- and QT- intervals	5 years
Secondary	Change in echocardiogram	Change from baseline in echocardiogram	5 years
Secondary	Change in chest x-ray	Change from baseline in chest x-ray	5 years
Secondary	Change in cardiac magnetic resonance imaging (cMRI)	Change from baseline in cMRI	5 years
Secondary	Change in cardiovascular magnetic resonance (CMR) imaging	Change from baseline in CMR	5 years
Secondary	Change in Multidetector (cardiac) computed tomography (MDCT)	Change from baseline in MDCT	5 years
Secondary	Adverse event rate	Rate of adverse events reported by PC treatment	5 years
Secondary	Changes in PROMIS-29 patient-reported outcomes	Change from baseline in PROMIS-29	5 years
Secondary	Changes in PROMIS Pediatric/Parent 25 patient-reported outcomes	Change from baseline in PROMIS Pediatric/Parent 25	5 years
Secondary	Changes in insomnia severity index (ISI) patient-reported outcomes	Change from baseline in ISI	5 years
Secondary	Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes	Change from baseline in PGIPS	5 years
Secondary	Changes in persistent pericarditis numerical rating scale (PPNRS) patient-reported outcomes	Change from baseline in PPNRS	5 years
Secondary	Changes in D12 patient-reported outcomes	Change from baseline in D12 outcome measures	5 years