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

February 13, 2026 updated by: Kiniksa Pharmaceuticals International, plc

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Alaska Heart & Vascular Institute
    • Arizona
      • Tucson, Arizona, United States, 85718
        • PIMA Heart and Vascular
    • California
      • La Jolla, California, United States, 92093
        • University of California San Diego Medical Center
      • Los Angeles, California, United States, 90048
        • Cedars-Sinai Medical Center
      • San Diego, California, United States, 92037
        • Scripps Health
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern University
    • Iowa
      • Davenport, Iowa, United States, 52801
        • Midwest Cardiovascular Research Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Johns Hopkins University
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Detroit Medical Center
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Minneapolis Heart Institute Foundation
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic - PPDS
    • Missouri
      • St Louis, Missouri, United States, 63110
        • Barnes-Jewish Hospital/Washington University
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • University of Nebraska
    • New Jersey
      • Fair Lawn, New Jersey, United States, 07410
        • TKL Research Inc.
    • New York
      • New York, New York, United States, 10016
        • NYU Langone Health
      • New York, New York, United States, 10075
        • Northwell Health - Lenox Hill Hospital
    • Ohio
      • Cincinnati, Ohio, United States, 45219
        • The Linder Research Center at The Christ Hospital
      • Cleveland, Ohio, United States, 44106
        • Cleveland Clinic
    • Oregon
      • Portland, Oregon, United States, 97227
        • Legacy Medical Group, Cardiology
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital
    • Texas
      • Dallas, Texas, United States, 75390
        • University of Texas Southwestern Medical Center
      • Houston, Texas, United States, 77030
        • Houston Methodist Hospital
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • University of Utah
    • Vermont
      • Burlington, Vermont, United States, 05405
        • University of Vermont Medical Center
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Virginia Commonwealth University
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital
      • Seattle, Washington, United States, 98122
        • Swedish Medical Center - Cherry Hill

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

7 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Active RP
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
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?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Patients using 1 or more RP treatments
Time Frame: 5 years
Proportion of patients using 1, 2, 3, or more concomitant RP treatments
5 years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Most frequently used RP treatments
Time Frame: 5 years
Number of subjects who used each treatment recorded during the study
5 years
Reduction in the use of corticosteroids
Time Frame: 5 years
Change from baseline through end of observation in corticosteroid use
5 years
Change in RP activity
Time Frame: 1 year
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
Time Frame: 5 years
Change from baseline in pericardial rub
5 years
Change in pericardial effusion
Time Frame: 5 years
Change from baseline in pericardial effusion
5 years
Change in fever
Time Frame: 5 years
Change from baseline in fever
5 years
Change in dyspnea
Time Frame: 5 years
Change from baseline in dyspnea
5 years
Change in C-reactive protein (CRP)
Time Frame: 5 years
Change from baseline in CRP
5 years
Change in erythrocyte sedimentation rate (ESR)
Time Frame: 5 years
Change from baseline in ESR
5 years
Change in white blood count (WBC)
Time Frame: 5 years
Change from baseline in WBC
5 years
Change in interleukin-1 (IL-1)
Time Frame: 5 years
Change from baseline in IL-1
5 years
Change in interleukin-6 (IL-6)
Time Frame: 5 years
Change from baseline in IL-6
5 years
Change in electrocardiogram (ECG)
Time Frame: 5 years
Change from baseline in ST-, PR-, QRS- and QT- intervals
5 years
Change in echocardiogram
Time Frame: 5 years
Change from baseline in echocardiogram
5 years
Change in chest x-ray
Time Frame: 5 years
Change from baseline in chest x-ray
5 years
Change in cardiac magnetic resonance imaging (cMRI)
Time Frame: 5 years
Change from baseline in cMRI
5 years
Change in cardiovascular magnetic resonance (CMR) imaging
Time Frame: 5 years
Change from baseline in CMR
5 years
Change in Multidetector (cardiac) computed tomography (MDCT)
Time Frame: 5 years
Change from baseline in MDCT
5 years
Adverse event rate
Time Frame: 5 years
Rate of adverse events reported by PC treatment
5 years
Changes in PROMIS-29 patient-reported outcomes
Time Frame: 5 years
Change from baseline in PROMIS-29
5 years
Changes in PROMIS Pediatric/Parent 25 patient-reported outcomes
Time Frame: 5 years
Change from baseline in PROMIS Pediatric/Parent 25
5 years
Changes in insomnia severity index (ISI) patient-reported outcomes
Time Frame: 5 years
Change from baseline in ISI
5 years
Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes
Time Frame: 5 years
Change from baseline in PGIPS
5 years
Changes in persistent pericarditis numerical rating scale (PPNRS) patient-reported outcomes
Time Frame: 5 years
Change from baseline in PPNRS
5 years
Changes in D12 patient-reported outcomes
Time Frame: 5 years
Change from baseline in D12 outcome measures
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Kiniksa Pharmaceuticals International, plc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Kiniksa Pharmaceuticals (UK), Ltd.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: John F Paolini, MD, PhD, Kiniksa Pharmaceuticals Corp

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 16, 2021

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2029

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2029

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
December 17, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 23, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 29, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KPL-914-Reg-001

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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