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

NCT ID: NCT04687358

Last Updated: 2025-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-03-16

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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Conditions

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Recurrent Pericarditis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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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).

No interventions assigned to this group

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.

No interventions assigned to this group

Eligibility Criteria

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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


* 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

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


* 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
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Kiniksa Pharmaceuticals (UK), Ltd.

INDUSTRY

Sponsor Role collaborator

Kiniksa Pharmaceuticals International, plc

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John F Paolini, MD, PhD

Role: STUDY_DIRECTOR

Kiniksa Pharmaceuticals Corp

Locations

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Alaska Heart & Vascular Institute

Anchorage, Alaska, United States

Site Status

Pima Heart and Vascular

Tucson, Arizona, United States

Site Status

University of California San Diego Medical Center

La Jolla, California, United States

Site Status

Cedars-Sinai Medical Center

Los Angeles, California, United States

Site Status

Scripps Health

San Diego, California, United States

Site Status

Northwestern University

Chicago, Illinois, United States

Site Status

Midwest Cardiovascular Research Foundation

Davenport, Iowa, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Massachusetts General Hospital

Boston, Massachusetts, United States

Site Status

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Detroit Medical Center

Detroit, Michigan, United States

Site Status

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, United States

Site Status

Mayo Clinic - PPDS

Rochester, Minnesota, United States

Site Status

Barnes-Jewish Hospital/Washington University

St Louis, Missouri, United States

Site Status

University of Nebraska

Omaha, Nebraska, United States

Site Status

TKL Research Inc.

Fair Lawn, New Jersey, United States

Site Status

NYU Langone Health

New York, New York, United States

Site Status

Northwell Health - Lenox Hill Hospital

New York, New York, United States

Site Status

The Linder Research Center at The Christ Hospital

Cincinnati, Ohio, United States

Site Status

Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Legacy Medical Group, Cardiology

Portland, Oregon, United States

Site Status

Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

University of Texas Southwestern Medical Center

Dallas, Texas, United States

Site Status

Houston Methodist Hospital

Houston, Texas, United States

Site Status

University of Utah

Salt Lake City, Utah, United States

Site Status

University of Vermont Medical Center

Burlington, Vermont, United States

Site Status

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status

Seattle Children's Hospital

Seattle, Washington, United States

Site Status

Swedish Medical Center - Cherry Hill

Seattle, Washington, United States

Site Status

Countries

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United States

Other Identifiers

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KPL-914-Reg-001

Identifier Type: -

Identifier Source: org_study_id

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