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Recurrent PericarditisRESONANCENCT04687358

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

An observational study of Recurrent Pericarditis, run by Kiniksa Pharmaceuticals International, plc at 29 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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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… Read more about this study

Who is it for?
Ages 7 years and older
Conditions the study is for
Recurrent Pericarditis
How many people
500 participants
Where
29 sitesUnited States
Study dates
16 Mar 2021to Mar 2029
How long will I take part?
5 Years
Phase
Observational
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 7 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

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.

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

Trial locations and contacts

29 sites in 1 country.

29 sites in 1 country

United States29 sites

  • Alaska Heart & Vascular Institute

    Anchorage, Alaska, 99508

  • Johns Hopkins University

    Baltimore, Maryland, 21218

  • Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • University of Vermont Medical Center

    Burlington, Vermont, 05405

  • Northwestern University

    Chicago, Illinois, 60611

  • The Linder Research Center at The Christ Hospital

    Cincinnati, Ohio, 45219

  • Cleveland Clinic

    Cleveland, Ohio, 44106

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • Midwest Cardiovascular Research Foundation

    Davenport, Iowa, 52801

  • Detroit Medical Center

    Detroit, Michigan, 48201

  • TKL Research Inc.

    Fair Lawn, New Jersey, 07410

  • Houston Methodist Hospital

    Houston, Texas, 77030

  • University of California San Diego Medical Center

    La Jolla, California, 92093

  • Cedars-Sinai Medical Center

    Los Angeles, California, 90048

  • Minneapolis Heart Institute Foundation

    Minneapolis, Minnesota, 55407

  • NYU Langone Health

    New York, New York, 10016

  • Northwell Health - Lenox Hill Hospital

    New York, New York, 10075

  • University of Nebraska

    Omaha, Nebraska, 68198

  • Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital

    Pittsburgh, Pennsylvania, 15212

  • Legacy Medical Group, Cardiology

    Portland, Oregon, 97227

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • Mayo Clinic - PPDS

    Rochester, Minnesota, 55905

  • University of Utah

    Salt Lake City, Utah, 84132

  • Scripps Health

    San Diego, California, 92037

  • Seattle Children's Hospital

    Seattle, Washington, 98105

  • Swedish Medical Center - Cherry Hill

    Seattle, Washington, 98122

  • Barnes-Jewish Hospital/Washington University

    St Louis, Missouri, 63110

  • Pima Heart and Vascular

    Tucson, Arizona, 85718

Other trials in United States

About this study

Official title: 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.

Medical subject headings
Pericarditis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT04687358
Study groupRoleWhat they receive
Active RPPatients 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 RPPatients 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. Patients using 1 or more RP treatments

    Proportion of patients using 1, 2, 3, or more concomitant RP treatments

    Measured: 5 years

Secondary outcomes (25)

  1. Most frequently used RP treatments

    Number of subjects who used each treatment recorded during the study

    Measured: 5 years

  2. Reduction in the use of corticosteroids

    Change from baseline through end of observation in corticosteroid use

    Measured: 5 years

  3. 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

    Measured: 1 year

  4. Change in pericardial rub

    Change from baseline in pericardial rub

    Measured: 5 years

  5. Change in pericardial effusion

    Change from baseline in pericardial effusion

    Measured: 5 years

  6. Change in fever

    Change from baseline in fever

    Measured: 5 years

  7. Change in dyspnea

    Change from baseline in dyspnea

    Measured: 5 years

  8. Change in C-reactive protein (CRP)

    Change from baseline in CRP

    Measured: 5 years

  9. Change in erythrocyte sedimentation rate (ESR)

    Change from baseline in ESR

    Measured: 5 years

  10. Change in white blood count (WBC)

    Change from baseline in WBC

    Measured: 5 years

  11. Change in interleukin-1 (IL-1)

    Change from baseline in IL-1

    Measured: 5 years

  12. Change in interleukin-6 (IL-6)

    Change from baseline in IL-6

    Measured: 5 years

  13. Change in electrocardiogram (ECG)

    Change from baseline in ST-, PR-, QRS- and QT- intervals

    Measured: 5 years

  14. Change in echocardiogram

    Change from baseline in echocardiogram

    Measured: 5 years

  15. Change in chest x-ray

    Change from baseline in chest x-ray

    Measured: 5 years

  16. Change in cardiac magnetic resonance imaging (cMRI)

    Change from baseline in cMRI

    Measured: 5 years

  17. Change in cardiovascular magnetic resonance (CMR) imaging

    Change from baseline in CMR

    Measured: 5 years

  18. Change in Multidetector (cardiac) computed tomography (MDCT)

    Change from baseline in MDCT

    Measured: 5 years

  19. Adverse event rate

    Rate of adverse events reported by PC treatment

    Measured: 5 years

  20. Changes in PROMIS-29 patient-reported outcomes

    Change from baseline in PROMIS-29

    Measured: 5 years

  21. Changes in PROMIS Pediatric/Parent 25 patient-reported outcomes

    Change from baseline in PROMIS Pediatric/Parent 25

    Measured: 5 years

  22. Changes in insomnia severity index (ISI) patient-reported outcomes

    Change from baseline in ISI

    Measured: 5 years

  23. Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes

    Change from baseline in PGIPS

    Measured: 5 years

  24. Changes in persistent pericarditis numerical rating scale (PPNRS) patient-reported outcomes

    Change from baseline in PPNRS

    Measured: 5 years

  25. Changes in D12 patient-reported outcomes

    Change from baseline in D12 outcome measures

    Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Dec 2020
  2. Study start16 Mar 2021
  3. Primary completionMar 2029 (estimated)
  4. Study completionMar 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Other
Enrolment
500 participants (estimated)
Target duration
5 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT04687358
Sponsor's protocol ID
KPL-914-Reg-001
Acronym
RESONANCE
Status last verified
Feb 2026
First submitted
17 Dec 2020
Last updated
17 Feb 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

An observational study of Recurrent Pericarditis, run by Kiniksa Pharmaceuticals International, plc at 29 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 29 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Patients using 1 or more RP treatments (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04687358.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.

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