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

• ClinicalTrials.gov Identifier: NCT04687358
• Recruitment Status: Recruiting
• First Posted: December 29, 2020
• Last Update Posted: February 3, 2022
• Sponsor: Kiniksa Pharmaceuticals (UK), Ltd.
• Information provided by (Responsible Party): Kiniksa Pharmaceuticals, Ltd. ( Kiniksa Pharmaceuticals (UK), Ltd. )

Study Description

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

Study Design

• 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

Groups and Cohorts

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.

Outcome Measures

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

Eligibility Criteria

• 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

Contacts and Locations

Contacts

Contact: JoAnn Clair, PhD; 7814319100; jclair@kiniksa.com

Locations

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

Cincinnati Children's Hospital Medical Center; Recruiting

Cincinnati, Ohio, United States, 45229

Contact: Mary Banks 513-636-2147 mary.banks@cchmc.org

Principal Investigator: Samuel Wittekind, MD

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

• Study Director: John F Paolini, MD, PhD, FACC; Kiniksa Pharmaceuticals Corp

More Information

• Responsible Party: Kiniksa Pharmaceuticals (UK), Ltd.
• ClinicalTrials.gov Identifier: NCT04687358
• Other Study ID Numbers: KPL-914-Reg-001
• First Posted: December 29, 2020
• Last Update Posted: February 3, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Undecided

• 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:

Pericarditis; Heart Diseases; Cardiovascular Diseases