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

Overview

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

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.

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

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

Closed-enrolling by invitation

What is this? (?)
"Close"
Not open to everyone who meets the eligibility criteria, but only those invited to participate by the study team.

Contact information:

Halley Davison

(507) 422-6246

davison.halley@mayo.edu

More information

Publications

Publications are currently not available