A Study to Analyze the Natural History of Recurrent Pericarditis in Pediatric and Adult Patients

Overview

Información sobre este estudio

The purpose of this study is to further 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.

Elegibilidad para la participación

Los requisitos de elegibilidad de los participantes incluyen la edad, el sexo, el tipo y el estadio de la enfermedad, y los problemas de salud o tratamientos previos. Las pautas difieren de un estudio a otro e identifican quiénes pueden o no pueden participar. No hay garantía de que cada persona elegible que desee participar en un ensayo se inscribirá. Comunícate con el equipo del estudio para analizar la elegibilidad del estudio y la posible participación.

Inclusion Criteria - Patients with Active Recurrent Pericarditis:

  • Physician-confirmed (or confirmation in medical records) diagnosis of Recurrent Pericarditis (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.
  • Able to read and understand English or Spanish.
  • Have access to technology to complete ePROs.
  • Provided informed consent or assent, as required by local regulations.

Inclusion Criteria - Patients with Inactive Recurrent Pericarditis:

  • 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 - Patients with Active Recurrent Pericarditis:

  • 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.

Exclusion Criteria - Patients with Inactive Recurrent Pericarditis:

  • 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.

Sedes participantes de Mayo Clinic

Los estatus de los estudios cambian con frecuencia. Comunícate con el equipo del estudio para obtener la información más actualizada acerca de la posibilidad de participar.

Sede de Mayo Clinic Estatus Contacto

Rochester, Minn.

Investigador principal de Mayo Clinic

Sushil Luis, M.B.B.S., Ph.D.

Cerrado; inscripción por invitación

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El estudio no está abierto para todos los que cumplen con los criterios de elegibilidad, sino solamente para las personas que el equipo del estudio ha invitado a participar.

Contact information:

Halley Davison

(507) 422-6246

davison.halley@mayo.edu

More information

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CLS-20515236

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