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

Kiniksa Pharmaceuticals International, plc

Status: Active, not recruiting

Conditions: Recurrent Pericarditis

Study type: Observational

Funder types: Industry

Identifiers

NCT04687358

KPL-914-Reg-001

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 7+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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

Trial design

500 participants in 2 patient groups

Active RP

Description:

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

Description:

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.