REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients
Purpose
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.
Condition
- Recurrent Pericarditis
Eligibility
- Eligible Ages
- Over 7 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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
Study Design
- Phase
- Study Type
- Observational [Patient Registry]
- Observational Model
- Cohort
- Time Perspective
- Other
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
| 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). | |
| 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. |
Recruiting Locations
Children's National and nearby locations
Children's National Hospital
Washington, District of Columbia 20010
Washington, District of Columbia 20010
More Details
- NCT ID
- NCT04687358
- Status
- Recruiting
- Sponsor
- Kiniksa Pharmaceuticals International, plc