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

April 8, 2024 updated by: Kiniksa Pharmaceuticals (UK), Ltd.

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

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

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 Locations

  • United States
    • Alaska
      • Anchorage, Alaska, United States, 99508
        • Recruiting
        • Alaska Heart & Vascular Institute
        • Contact:
        • Principal Investigator:
          • Suneet Purohit, MD
    • Arizona
      • Tucson, Arizona, United States, 85718
    • California
      • La Jolla, California, United States, 92093
        • Recruiting
        • University of California San Diego Medical Center
        • Principal Investigator:
          • Nicholas Phreaner, MD
        • Contact:
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars Sinai Medical Center
        • Principal Investigator:
          • Robert J Siegel, MD
        • Contact:
      • Los Angeles, California, United States, 90048
        • Recruiting
        • Cedars-Sinai Medical Center
        • Contact:
        • Contact:
          • Karen Yanes
        • Principal Investigator:
          • Robert J Siegel, MD
      • San Diego, California, United States, 92037
        • Recruiting
        • Scripps Health
        • Contact:
        • Principal Investigator:
          • Austin Robinson, MD
    • District of Columbia
      • Washington, District of Columbia, United States, 20010
        • Recruiting
        • Children's National Hospital
        • Contact:
        • Principal Investigator:
          • Ashraf Harahsheh, MD
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Recruiting
        • Northwestern University
        • Contact:
        • Principal Investigator:
          • Mohammed Al-Kazaz, MD
    • Iowa
      • Davenport, Iowa, United States, 52801
        • Active, not recruiting
        • Midwest Cardiovascular Research Foundation
    • Maryland
      • Baltimore, Maryland, United States, 21218
        • Recruiting
        • Johns Hopkins University
        • Contact:
        • Principal Investigator:
          • Luigi Adamo, MD, PHD
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Recruiting
        • Brigham and Women's Hospital
        • Principal Investigator:
          • Brittany N Weber, MD, PhD
        • Contact:
      • Boston, Massachusetts, United States, 02114
        • Recruiting
        • Massachusetts General Hospital
        • Principal Investigator:
          • Jonathan Salik, MD
        • Contact:
    • Michigan
      • Detroit, Michigan, United States, 48201
        • Recruiting
        • Detroit Medical Center
        • Contact:
        • Principal Investigator:
          • Chadi Alrais, MD
    • Minnesota
      • Minneapolis, Minnesota, United States, 55407
        • Recruiting
        • Minneapolis Heart Institute Foundation
        • Principal Investigator:
          • David Lin, MD
        • Contact:
      • Rochester, Minnesota, United States, 55905
        • Recruiting
        • Mayo Clinic - PPDS
        • Contact:
        • Principal Investigator:
          • S. Allen Luis, MD
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Recruiting
        • Barnes-Jewish Hospital/Washington University
        • Contact:
        • Principal Investigator:
          • Amanda Verma, MD
    • Nebraska
      • Omaha, Nebraska, United States, 68198
        • Active, not recruiting
        • University of Nebraska
    • New Jersey
      • Fair Lawn, New Jersey, United States, 07410
        • Recruiting
        • TKL Research Inc.
        • Principal Investigator:
          • Jesson Yeh, MD
        • Contact:
    • New York
      • New York, New York, United States, 10016
      • New York, New York, United States, 10075
        • Recruiting
        • Northwell Health - Lenox Hill Hospital
        • Contact:
        • Principal Investigator:
          • Finkielstein, MD
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
        • Contact:
        • Principal Investigator:
          • Sarosh P. Batlivala, MD
      • Cincinnati, Ohio, United States, 45219
      • Cleveland, Ohio, United States, 44106
        • Recruiting
        • Cleveland Clinic
        • Contact:
        • Principal Investigator:
          • Allan Klein, MD
    • Oregon
      • Portland, Oregon, United States, 97227
        • Active, not recruiting
        • Legacy Medical Group, Cardiology
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15212
        • Recruiting
        • Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital
        • Contact:
        • Principal Investigator:
          • Moneal Shah, MD
    • Texas
      • Dallas, Texas, United States, 75390
        • Recruiting
        • University of Texas Southwestern Medical Center
        • Contact:
        • Principal Investigator:
          • Kathleen Zhang, MD
      • Houston, Texas, United States, 77030
        • Recruiting
        • Houston Methodist Hospital
        • Contact:
        • Principal Investigator:
          • Dipan Shah, MD
    • Utah
      • Salt Lake City, Utah, United States, 84132
        • Recruiting
        • University of Utah
        • Contact:
        • Principal Investigator:
          • John Ryan, MD
    • Vermont
      • Burlington, Vermont, United States, 05405
        • Recruiting
        • University of Vermont Medical Center
        • Contact:
        • Principal Investigator:
          • Tracy Hagerty, MD
    • Virginia
      • Richmond, Virginia, United States, 23298
        • Recruiting
        • Virginia Commonwealth University
        • Contact:
        • Principal Investigator:
          • Georgia Thomas, MD
    • Washington

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

Ages Eligible for Study

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

Accepts Healthy Volunteers

N/A

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
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

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

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

Kiniksa Pharmaceuticals (UK), Ltd.

Investigators

  • 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)

March 16, 2021

Primary Completion (Estimated)

February 1, 2026

Study Completion (Estimated)

February 1, 2026

Study Registration Dates

First Submitted

December 17, 2020

First Submitted That Met QC Criteria

December 23, 2020

First Posted (Actual)

December 29, 2020

Study Record Updates

Last Update Posted (Actual)

April 9, 2024

Last Update Submitted That Met QC Criteria

April 8, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID 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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