Clinical trial NCT04687358: REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients
Official title: Registry of the Natural History of Recurrent Pericarditis in Pediatric and Adult Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Recurrent Pericarditis
Lead sponsor: Kiniksa Pharmaceuticals International, plc
Sponsor class: INDUSTRY
Collaborators: name: Kiniksa Pharmaceuticals (UK), Ltd.
First posted: 2020-12-29
Enrollment: 500
Sex: ALL
Minimum age (years): 7
Standard ages: CHILD
ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with active or inactive recurrent pericarditis who have participated in the RHAPSODY (KPL-914-C002) Phase 3 clinical study of rilonacept and patients from sites who have expressed an interest in the registry will be included. In addition, RESONANCE will also include decentralized sites for remote patients who wish to participate in the registry but are not near a registry site.

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.


Eligibility 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 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

Primary outcomes:
measure: Patients using 1 or more RP treatments
timeFrame: 5 years
Secondary outcomes:
measure: Most frequently used RP treatments
timeFrame: 5 years
measure: Reduction in the use of corticosteroids
timeFrame: 5 years
measure: Change in RP activity
timeFrame: 1 year
measure: Change in pericardial rub
timeFrame: 5 years
measure: Change in pericardial effusion
timeFrame: 5 years
measure: Change in fever
timeFrame: 5 years
measure: Change in dyspnea
timeFrame: 5 years
measure: Change in C-reactive protein (CRP)
timeFrame: 5 years
measure: Change in erythrocyte sedimentation rate (ESR)
timeFrame: 5 years
measure: Change in white blood count (WBC)
timeFrame: 5 years
measure: Change in interleukin-1 (IL-1)
timeFrame: 5 years
measure: Change in interleukin-6 (IL-6)
timeFrame: 5 years
measure: Change in electrocardiogram (ECG)
timeFrame: 5 years
measure: Change in echocardiogram
timeFrame: 5 years
measure: Change in chest x-ray
timeFrame: 5 years
measure: Change in cardiac magnetic resonance imaging (cMRI)
timeFrame: 5 years
measure: Change in cardiovascular magnetic resonance (CMR) imaging
timeFrame: 5 years
measure: Change in Multidetector (cardiac) computed tomography (MDCT)
timeFrame: 5 years
measure: Adverse event rate
timeFrame: 5 years
measure: Changes in PROMIS-29 patient-reported outcomes
timeFrame: 5 years
measure: Changes in PROMIS Pediatric/Parent 25 patient-reported outcomes
timeFrame: 5 years
measure: Changes in insomnia severity index (ISI) patient-reported outcomes
timeFrame: 5 years
measure: Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes
timeFrame: 5 years
measure: Changes in persistent pericarditis numerical rating scale (PPNRS) patient-reported outcomes
timeFrame: 5 years
measure: Changes in D12 patient-reported outcomes
timeFrame: 5 years
Other outcomes:
Locations:
city: Anchorage
country: United States
facility: Alaska Heart & Vascular Institute
state: Alaska
city: Tucson
country: United States
facility: Pima Heart and Vascular
state: Arizona
city: La Jolla
country: United States
facility: University of California San Diego Medical Center
state: California
city: Los Angeles
country: United States
facility: Cedars-Sinai Medical Center
state: California
city: San Diego
country: United States
facility: Scripps Health
state: California
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Davenport
country: United States
facility: Midwest Cardiovascular Research Foundation
state: Iowa
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
city: Boston
country: United States
facility: Brigham and Women's Hospital
state: Massachusetts
city: Detroit
country: United States
facility: Detroit Medical Center
state: Michigan
city: Minneapolis
country: United States
facility: Minneapolis Heart Institute Foundation
state: Minnesota
city: Rochester
country: United States
facility: Mayo Clinic - PPDS
state: Minnesota
city: Saint Louis
country: United States
facility: Barnes-Jewish Hospital/Washington University
state: Missouri
city: Omaha
country: United States
facility: University of Nebraska
state: Nebraska
city: Fair Lawn
country: United States
facility: TKL Research Inc.
state: New Jersey
city: New York
country: United States
facility: NYU Langone Health
state: New York
city: New York
country: United States
facility: Northwell Health - Lenox Hill Hospital
state: New York
city: Cincinnati
country: United States
facility: The Linder Research Center at The Christ Hospital
state: Ohio
city: Cleveland
country: United States
facility: Cleveland Clinic
state: Ohio
city: Portland
country: United States
facility: Legacy Medical Group, Cardiology
state: Oregon
city: Pittsburgh
country: United States
facility: Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital
state: Pennsylvania
city: Dallas
country: United States
facility: University of Texas Southwestern Medical Center
state: Texas
city: Houston
country: United States
facility: Houston Methodist Hospital
state: Texas
city: Salt Lake City
country: United States
facility: University of Utah
state: Utah
city: Burlington
country: United States
facility: University of Vermont Medical Center
state: Vermont
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
city: Seattle
country: United States
facility: Seattle Children's Hospital
state: Washington
city: Seattle
country: United States
facility: Swedish Medical Center - Cherry Hill
state: Washington
Study officials:
affiliation: Kiniksa Pharmaceuticals Corp
name: John F Paolini, MD, PhD
role: STUDY_DIRECTOR
References: