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

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ClinicalTrials.gov Identifier: NCT04687358
Recruitment Status : Recruiting
First Posted : December 29, 2020
Last Update Posted : December 1, 2021
Sponsor:
Information provided by (Responsible Party):
Kiniksa Pharmaceuticals, Ltd. ( Kiniksa Pharmaceuticals (UK), Ltd. )

Brief 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.

Condition or disease
Recurrent Pericarditis

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 500 participants
Observational Model: Cohort
Time Perspective: Other
Target Follow-Up Duration: 5 Years
Official Title: Registry of the Natural History of Recurrent Pericarditis in Pediatric and Adult Patients
Actual Study Start Date : March 16, 2021
Estimated Primary Completion Date : February 2026
Estimated Study Completion Date : February 2026

Resource links provided by the National Library of Medicine


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.



Primary Outcome Measures :
  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 Outcome Measures :
  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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   7 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
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.
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 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04687358


Contacts
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Contact: Alison Reid 7814319100 areid@kiniksa.com

Locations
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United States, Alaska
Alaska Heart & Vascular Institute Recruiting
Anchorage, Alaska, United States, 99508
Contact: Amanda Chriswell    907-550-2247    achriswell@alaskaheart.com   
Principal Investigator: Suneet Purohit, MD         
United States, Arizona
Pima Heart and Vascular Recruiting
Tucson, Arizona, United States, 85718
Contact: Aleksander Herber    520-576-4133    aleksander.herber@pimaheartandvascular.com   
Principal Investigator: Thomas Waggoner, MD         
United States, California
University of California San Diego Medical Center Recruiting
La Jolla, California, United States, 92093
Contact: Study Coordinator    858-246-2413      
Principal Investigator: Ajit Raisinghani, MD         
United States, Iowa
Midwest Cardiovascular Research Foundation Recruiting
Davenport, Iowa, United States, 52803
Contact: Lori Christensen    563-324-2828    christensenl@mcrfmd.com   
Principal Investigator: Nicholas Shammas, MD         
United States, Minnesota
Minneapolis Heart Institute Foundation Recruiting
Minneapolis, Minnesota, United States, 55407
Contact: Stephanie Ebnet    612-863-3833      
Principal Investigator: David Lin         
Mayo Clinic - PPDS Recruiting
Rochester, Minnesota, United States, 55905
Contact    507-422-6246    davison.halley@mayo.edu   
Principal Investigator: Luis, MD         
United States, Missouri
Barnes-Jewish Hospital/Washington University Recruiting
Saint Louis, Missouri, United States, 63110
Contact    314-286-1767    Karen.bult@wustl.edu   
Principal Investigator: Amanda Verma, MD         
United States, New Jersey
TKL Research Inc. Recruiting
Fair Lawn, New Jersey, United States, 07410
Contact: Uzoma Okamgba-Nwoke    201-587-0500 ext 2548    unwoke@tklresearch.com   
Principal Investigator: Steven Schreiber, MD         
United States, New York
NYU Langone Health Recruiting
New York, New York, United States, 10016
Contact    212-263-0855    Alexander.Auchus@nyulangone.org   
Principal Investigator: Michael Garshick, MD         
Northwell Health - Lenox Hill Hospital Recruiting
New York, New York, United States, 10075
Contact    212-434-4174    estrober@northwell.edu   
Principal Investigator: Finkielstein, MD         
United States, Ohio
Cleveland Clinic Recruiting
Cleveland, Ohio, United States, 44106
Contact    216-445-9007    MIHALUS@ccf.org   
Principal Investigator: Paul Cremer, MD         
United States, Oregon
Legacy Hospital and Health Center DBA Legacy Research Institute Recruiting
Portland, Oregon, United States, 97232
Contact    503-413-1612    kkummer@lhs.org   
Principal Investigator: Desai, MD         
United States, Pennsylvania
Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital Recruiting
Pittsburgh, Pennsylvania, United States, 15212
Contact: Geetha Rayarao    412-359-4076      
Principal Investigator: Robert Biederman         
United States, Virginia
Virginia Commonwealth University Recruiting
Richmond, Virginia, United States, 23298
Contact    804-828-2775    Emily.Federmann@vcuhealth.org   
Principal Investigator: Georgia Thomas, MD         
United States, Washington
Seattle Children's Hospital Recruiting
Seattle, Washington, United States, 98105
Contact    206-987-1014    Deepthi.Nair@seattlechildrens.org   
Contact       Hademi.kajimoto@seattlechildrens.org   
Principal Investigator: Michael Portman, MD         
Sponsors and Collaborators
Kiniksa Pharmaceuticals (UK), Ltd.
Investigators
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Study Director: John F Paolini, MD, PhD, FACC Kiniksa Pharmaceuticals Corp
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Responsible Party: Kiniksa Pharmaceuticals (UK), Ltd.
ClinicalTrials.gov Identifier: NCT04687358    
Other Study ID Numbers: KPL-914-Reg-001
First Posted: December 29, 2020    Key Record Dates
Last Update Posted: December 1, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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
Additional relevant MeSH terms:
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Pericarditis
Heart Diseases
Cardiovascular Diseases