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Active, not recruitingNCT04687358RESONANCEUpdated Feb 17, 2026

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

An observational study in Recurrent Pericarditis, sponsored by Kiniksa Pharmaceuticals International, plc. Active, not recruiting at 29 sites in United States. Open to participants aged 7 Years and older. Per ClinicalTrials.gov, last updated 2026-02-17.

Sponsored by Kiniksa Pharmaceuticals International, plc · Observational

Study type
Observational
Model
Cohort
Time perspective
Other
Enrollment
500
Ages
7 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Recurrent Pericarditis

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03

In context

Pericarditis

54 studies on the registry are indexed under Pericarditis; 23 are open to participants now.

This study's planned enrollment of 500 is above the median of 300 across 25 observational studies indexed under Pericarditis.

Browse Pericarditis studies →

Lead sponsor

Kiniksa Pharmaceuticals International, plc is the lead sponsor of 5 studies on the registry; 2 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
7 Years and older
Sexes eligible
All
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.

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 diseases, except SJIA and adult Still's disease,
  • 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 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
Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

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Study design

Observational model
Cohort
Time perspective
Other
Enrollment
500 participants (estimated)
Target follow-up
5 Years
Patient registry
Yes

Groups and cohorts

  • 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.

06

What researchers measure

Primary outcomes

  1. Patients using 1 or more RP treatments

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

    Time frame: 5 years

Secondary outcomes

  1. Most frequently used RP treatments

    Number of subjects who used each treatment recorded during the study

    Time frame: 5 years

  2. Reduction in the use of corticosteroids

    Change from baseline through end of observation in corticosteroid use

    Time frame: 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

    Time frame: 1 year

  4. Change in pericardial rub

    Change from baseline in pericardial rub

    Time frame: 5 years

  5. Change in pericardial effusion

    Change from baseline in pericardial effusion

    Time frame: 5 years

  6. Change in fever

    Change from baseline in fever

    Time frame: 5 years

  7. Change in dyspnea

    Change from baseline in dyspnea

    Time frame: 5 years

  8. Change in C-reactive protein (CRP)

    Change from baseline in CRP

    Time frame: 5 years

  9. Change in erythrocyte sedimentation rate (ESR)

    Change from baseline in ESR

    Time frame: 5 years

  10. Change in white blood count (WBC)

    Change from baseline in WBC

    Time frame: 5 years

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

    Change from baseline in IL-1

    Time frame: 5 years

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

    Change from baseline in IL-6

    Time frame: 5 years

  13. Change in electrocardiogram (ECG)

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

    Time frame: 5 years

  14. Change in echocardiogram

    Change from baseline in echocardiogram

    Time frame: 5 years

  15. Change in chest x-ray

    Change from baseline in chest x-ray

    Time frame: 5 years

  16. Change in cardiac magnetic resonance imaging (cMRI)

    Change from baseline in cMRI

    Time frame: 5 years

  17. Change in cardiovascular magnetic resonance (CMR) imaging

    Change from baseline in CMR

    Time frame: 5 years

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

    Change from baseline in MDCT

    Time frame: 5 years

  19. Adverse event rate

    Rate of adverse events reported by PC treatment

    Time frame: 5 years

  20. Changes in PROMIS-29 patient-reported outcomes

    Change from baseline in PROMIS-29

    Time frame: 5 years

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

    Change from baseline in PROMIS Pediatric/Parent 25

    Time frame: 5 years

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

    Change from baseline in ISI

    Time frame: 5 years

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

    Change from baseline in PGIPS

    Time frame: 5 years

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

    Change from baseline in PPNRS

    Time frame: 5 years

  25. Changes in D12 patient-reported outcomes

    Change from baseline in D12 outcome measures

    Time frame: 5 years

07

Study locations

29 sites
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04687358
Lead sponsor
Kiniksa Pharmaceuticals International, plc
Collaborators
Kiniksa Pharmaceuticals (UK), Ltd.
Responsible party
Sponsor
First posted
Dec 29, 2020
Start date
Mar 16, 2021
Primary completion
Mar 2029 (estimated)
Completion
Mar 2029 (estimated)
Last update
Feb 17, 2026

Study contacts

John F Paolini, MD, PhD
study director · Kiniksa Pharmaceuticals Corp

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Feb 2026. You cannot join it, but the record below documents what was studied.

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