REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients
NCT ID: NCT04687358
Last Updated: 2025-04-29
Study Results
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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ACTIVE_NOT_RECRUITING
500 participants
OBSERVATIONAL
2021-03-16
2026-02-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
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
* 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
* 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
7 Years
ALL
No
Sponsors
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Kiniksa Pharmaceuticals (UK), Ltd.
INDUSTRY
Kiniksa Pharmaceuticals International, plc
INDUSTRY
Responsible Party
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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
Pima Heart and Vascular
Tucson, Arizona, United States
University of California San Diego Medical Center
La Jolla, California, United States
Cedars-Sinai Medical Center
Los Angeles, California, United States
Scripps Health
San Diego, California, United States
Northwestern University
Chicago, Illinois, United States
Midwest Cardiovascular Research Foundation
Davenport, Iowa, United States
Johns Hopkins University
Baltimore, Maryland, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Detroit Medical Center
Detroit, Michigan, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Mayo Clinic - PPDS
Rochester, Minnesota, United States
Barnes-Jewish Hospital/Washington University
St Louis, Missouri, United States
University of Nebraska
Omaha, Nebraska, United States
TKL Research Inc.
Fair Lawn, New Jersey, United States
NYU Langone Health
New York, New York, United States
Northwell Health - Lenox Hill Hospital
New York, New York, United States
The Linder Research Center at The Christ Hospital
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Legacy Medical Group, Cardiology
Portland, Oregon, United States
Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital
Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center
Dallas, Texas, United States
Houston Methodist Hospital
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
University of Vermont Medical Center
Burlington, Vermont, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Seattle Children's Hospital
Seattle, Washington, United States
Swedish Medical Center - Cherry Hill
Seattle, Washington, United States
Countries
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Other Identifiers
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KPL-914-Reg-001
Identifier Type: -
Identifier Source: org_study_id
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