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Active, Not Recruiting

NCT Number: NCT04687358

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

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Key information

Age range

7 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Alaska Heart & Vascular Institute, Anchorage, Alaska, United States

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Patients using 1 or more RP treatments

    Time frame: 5 years

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

Secondary outcomes

  1. Most frequently used RP treatments

    Time frame: 5 years

    Number of subjects who used each treatment recorded during the study

  2. Reduction in the use of corticosteroids

    Time frame: 5 years

    Change from baseline through end of observation in corticosteroid use

  3. 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

  4. Change in pericardial rub

    Time frame: 5 years

    Change from baseline in pericardial rub

  5. Change in pericardial effusion

    Time frame: 5 years

    Change from baseline in pericardial effusion

  6. Change in fever

    Time frame: 5 years

    Change from baseline in fever

  7. Change in dyspnea

    Time frame: 5 years

    Change from baseline in dyspnea

  8. Change in C-reactive protein (CRP)

    Time frame: 5 years

    Change from baseline in CRP

  9. Change in erythrocyte sedimentation rate (ESR)

    Time frame: 5 years

    Change from baseline in ESR

  10. Change in white blood count (WBC)

    Time frame: 5 years

    Change from baseline in WBC

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

    Time frame: 5 years

    Change from baseline in IL-1

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

    Time frame: 5 years

    Change from baseline in IL-6

  13. Change in electrocardiogram (ECG)

    Time frame: 5 years

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

  14. Change in echocardiogram

    Time frame: 5 years

    Change from baseline in echocardiogram

  15. Change in chest x-ray

    Time frame: 5 years

    Change from baseline in chest x-ray

  16. Change in cardiac magnetic resonance imaging (cMRI)

    Time frame: 5 years

    Change from baseline in cMRI

  17. Change in cardiovascular magnetic resonance (CMR) imaging

    Time frame: 5 years

    Change from baseline in CMR

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

    Time frame: 5 years

    Change from baseline in MDCT

  19. Adverse event rate

    Time frame: 5 years

    Rate of adverse events reported by PC treatment

  20. Changes in PROMIS-29 patient-reported outcomes

    Time frame: 5 years

    Change from baseline in PROMIS-29

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

    Time frame: 5 years

    Change from baseline in PROMIS Pediatric/Parent 25

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

    Time frame: 5 years

    Change from baseline in ISI

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

    Time frame: 5 years

    Change from baseline in PGIPS

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

    Time frame: 5 years

    Change from baseline in PPNRS

  25. Changes in D12 patient-reported outcomes

    Time frame: 5 years

    Change from baseline in D12 outcome measures

Sponsors and collaborators

Lead sponsor

Kiniksa Pharmaceuticals International, plc

Industry

Collaborators

  • Kiniksa Pharmaceuticals (UK), Ltd.

Registry information

Acronym: RESONANCE

Important dates

Study start
2021
Primary completion
2029
Study completion
2029
First posted
Dec 29, 2020
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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