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

NCT04687358 | Active Not Recruiting

• 1 other identifier: KPL-914-Reg-001
• Study Type: observational
• Target: 500
• Locations: 1 country
• Sites: 29

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.

Conditions

Recurrent Pericarditis

Outcome Measures

Primary Outcomes (1)

• Patients using 1 or more RP treatments

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

  5 years

Secondary Outcomes (25)

• Most frequently used RP treatments

  5 years

• Reduction in the use of corticosteroids

  5 years

• Change in RP activity

  1 year

• Change in pericardial rub

  5 years

• Change in pericardial effusion

  5 years

Study Arms (2)

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.

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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
• Under the care of a physician for the treatment and management of RP
• Currently prescribed medication for RP

You may not qualify if:

• 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
• 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
• Resolution of RP symptoms confirmed with no further RP treatment for 3 years prior to registry enrollment
• 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

Sponsors & Collaborators

• Kiniksa Pharmaceuticals International, plc: lead
• Kiniksa Pharmaceuticals (UK), Ltd.: collaborator

Study Sites (29)

Alaska Heart & Vascular Institute

Anchorage, Alaska, 99508, United States

Location

Pima Heart and Vascular

Tucson, Arizona, 85718, United States

Location

University of California San Diego Medical Center

La Jolla, California, 92093, United States

Location

Cedars-Sinai Medical Center

Los Angeles, California, 90048, United States

Location

Scripps Health

San Diego, California, 92037, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Midwest Cardiovascular Research Foundation

Davenport, Iowa, 52801, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21218, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Detroit Medical Center

Detroit, Michigan, 48201, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Mayo Clinic - PPDS

Rochester, Minnesota, 55905, United States

Location

Barnes-Jewish Hospital/Washington University

St Louis, Missouri, 63110, United States

Location

University of Nebraska

Omaha, Nebraska, 68198, United States

Location

TKL Research Inc.

Fair Lawn, New Jersey, 07410, United States

Location

NYU Langone Health

New York, New York, 10016, United States

Location

Northwell Health - Lenox Hill Hospital

New York, New York, 10075, United States

Location

The Linder Research Center at The Christ Hospital

Cincinnati, Ohio, 45219, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44106, United States

Location

Legacy Medical Group, Cardiology

Portland, Oregon, 97227, United States

Location

Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital

Pittsburgh, Pennsylvania, 15212, United States

Location

University of Texas Southwestern Medical Center

Dallas, Texas, 75390, United States

Location

Houston Methodist Hospital

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84132, United States

Location

University of Vermont Medical Center

Burlington, Vermont, 05405, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Seattle Children's Hospital

Seattle, Washington, 98105, United States

Location

Swedish Medical Center - Cherry Hill

Seattle, Washington, 98122, United States

Location

MeSH Terms

Conditions

Pericarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• John F Paolini, MD, PhD

  Kiniksa Pharmaceuticals Corp

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Target Duration: 5 Years
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2020
• First Posted: December 29, 2020
• Study Start: March 16, 2021
• Primary Completion (Estimated): March 1, 2029
• Study Completion (Estimated): March 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Locations

US (29)