NCT04687358Active, not recruitingNot Applicable
Registry of the Natural History of Recurrent Pericarditis in Pediatric and Adult Patients
Kiniksa Pharmaceuticals International, plc29 sites in 1 country500 target enrollmentStarted: March 16, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 500
- Locations
- 29
- Primary Endpoint
- Patients using 1 or more RP treatments
Study Overview
Brief Summary
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Other
Eligibility Criteria
- Ages
- 7 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion 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
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
Arms & Interventions
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.
Outcomes
Primary Outcomes
Patients using 1 or more RP treatments
Time Frame: 5 years
Proportion of patients using 1, 2, 3, or more concomitant RP treatments
Secondary Outcomes
- Adverse event rate(5 years)
- Change in cardiovascular magnetic resonance (CMR) imaging(5 years)
- Changes in PROMIS-29 patient-reported outcomes(5 years)
- Changes in PROMIS Pediatric/Parent 25 patient-reported outcomes(5 years)
- Changes in insomnia severity index (ISI) patient-reported outcomes(5 years)
- Change in cardiac magnetic resonance imaging (cMRI)(5 years)
- Change in dyspnea(5 years)
- Change in echocardiogram(5 years)
- Change in fever(5 years)
- Change in Multidetector (cardiac) computed tomography (MDCT)(5 years)
- Change in C-reactive protein (CRP)(5 years)
- Change in interleukin-1 (IL-1)(5 years)
- Change in chest x-ray(5 years)
- Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes(5 years)
- Change in interleukin-6 (IL-6)(5 years)
- Most frequently used RP treatments(5 years)
- Reduction in the use of corticosteroids(5 years)
- Change in RP activity(1 year)
- Change in pericardial rub(5 years)
- Change in pericardial effusion(5 years)
- Change in erythrocyte sedimentation rate (ESR)(5 years)
- Change in white blood count (WBC)(5 years)
- Change in electrocardiogram (ECG)(5 years)
- Changes in persistent pericarditis numerical rating scale (PPNRS) patient-reported outcomes(5 years)
- Changes in D12 patient-reported outcomes(5 years)
Investigators
Study Sites (29)
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