Ignite Creation Date:
2025-12-25 @ 12:24 AM
Ignite Modification Date:
2025-12-28 @ 11:52 PM
Study NCT ID:
NCT04687358
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-04-29
First Post:
2020-12-17
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010493', 'term': 'Pericarditis'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-03-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-25', 'studyFirstSubmitDate': '2020-12-17', 'studyFirstSubmitQcDate': '2020-12-23', 'lastUpdatePostDateStruct': {'date': '2025-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Patients using 1 or more RP treatments', 'timeFrame': '5 years', 'description': 'Proportion of patients using 1, 2, 3, or more concomitant RP treatments'}], 'secondaryOutcomes': [{'measure': 'Most frequently used RP treatments', 'timeFrame': '5 years', 'description': 'Number of subjects who used each treatment recorded during the study'}, {'measure': 'Reduction in the use of corticosteroids', 'timeFrame': '5 years', 'description': 'Change from baseline through end of observation in corticosteroid use'}, {'measure': 'Change in RP activity', 'timeFrame': '1 year', 'description': 'Change from baseline in RP disease recurrences within 1 year (from 1 year prior to baseline to 1 year after baseline'}, {'measure': 'Change in pericardial rub', 'timeFrame': '5 years', 'description': 'Change from baseline in pericardial rub'}, {'measure': 'Change in pericardial effusion', 'timeFrame': '5 years', 'description': 'Change from baseline in pericardial effusion'}, {'measure': 'Change in fever', 'timeFrame': '5 years', 'description': 'Change from baseline in fever'}, {'measure': 'Change in dyspnea', 'timeFrame': '5 years', 'description': 'Change from baseline in dyspnea'}, {'measure': 'Change in C-reactive protein (CRP)', 'timeFrame': '5 years', 'description': 'Change from baseline in CRP'}, {'measure': 'Change in erythrocyte sedimentation rate (ESR)', 'timeFrame': '5 years', 'description': 'Change from baseline in ESR'}, {'measure': 'Change in white blood count (WBC)', 'timeFrame': '5 years', 'description': 'Change from baseline in WBC'}, {'measure': 'Change in interleukin-1 (IL-1)', 'timeFrame': '5 years', 'description': 'Change from baseline in IL-1'}, {'measure': 'Change in interleukin-6 (IL-6)', 'timeFrame': '5 years', 'description': 'Change from baseline in IL-6'}, {'measure': 'Change in electrocardiogram (ECG)', 'timeFrame': '5 years', 'description': 'Change from baseline in ST-, PR-, QRS- and QT- intervals'}, {'measure': 'Change in echocardiogram', 'timeFrame': '5 years', 'description': 'Change from baseline in echocardiogram'}, {'measure': 'Change in chest x-ray', 'timeFrame': '5 years', 'description': 'Change from baseline in chest x-ray'}, {'measure': 'Change in cardiac magnetic resonance imaging (cMRI)', 'timeFrame': '5 years', 'description': 'Change from baseline in cMRI'}, {'measure': 'Change in cardiovascular magnetic resonance (CMR) imaging', 'timeFrame': '5 years', 'description': 'Change from baseline in CMR'}, {'measure': 'Change in Multidetector (cardiac) computed tomography (MDCT)', 'timeFrame': '5 years', 'description': 'Change from baseline in MDCT'}, {'measure': 'Adverse event rate', 'timeFrame': '5 years', 'description': 'Rate of adverse events reported by PC treatment'}, {'measure': 'Changes in PROMIS-29 patient-reported outcomes', 'timeFrame': '5 years', 'description': 'Change from baseline in PROMIS-29'}, {'measure': 'Changes in PROMIS Pediatric/Parent 25 patient-reported outcomes', 'timeFrame': '5 years', 'description': 'Change from baseline in PROMIS Pediatric/Parent 25'}, {'measure': 'Changes in insomnia severity index (ISI) patient-reported outcomes', 'timeFrame': '5 years', 'description': 'Change from baseline in ISI'}, {'measure': 'Changes in Patient Global Impression of Pericarditis Severity (PGIPS) patient-reported outcomes', 'timeFrame': '5 years', 'description': 'Change from baseline in PGIPS'}, {'measure': 'Changes in persistent pericarditis numerical rating scale (PPNRS) patient-reported outcomes', 'timeFrame': '5 years', 'description': 'Change from baseline in PPNRS'}, {'measure': 'Changes in D12 patient-reported outcomes', 'timeFrame': '5 years', 'description': 'Change from baseline in D12 outcome measures'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Recurrent Pericarditis']}, 'descriptionModule': {'briefSummary': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '7 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with active or inactive recurrent pericarditis who have participated in the RHAPSODY (KPL-914-C002) Phase 3 clinical study of rilonacept and patients from sites who have expressed an interest in the registry will be included. In addition, RESONANCE will also include decentralized sites for remote patients who wish to participate in the registry but are not near a registry site.', 'eligibilityCriteria': "ACTIVE RP PATIENTS\n\nSelect Inclusion Criteria:\n\n* 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\n* Experienced at least one pericarditis episode in the 3 years prior to inclusion\n* Under the care of a physician for the treatment and management of RP\n* Currently prescribed medication for RP\n\nSelect Exclusion Criteria:\n\n* 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\n* 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\n* Currently enrolled in a therapeutic investigational drug or device study\n\nINACTIVE RP PATIENTS\n\nSelect Inclusion Criteria:\n\n* 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\n* Patient had a last episode occurring at least 3 years and up to 5 years before registry inclusion\n* Resolution of RP symptoms confirmed with no further RP treatment for 3 years prior to registry enrollment\n\nSelect Exclusion Criteria:\n\n* Experienced a pericarditis episode within 3 years from enrolling in the registry\n* Currently receiving RP treatment prescribed by a treating physician (e.g., CS, colchicine)\n* 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\n* Enrolled in a therapeutic investigational clinical trial during the observation period"}, 'identificationModule': {'nctId': 'NCT04687358', 'acronym': 'RESONANCE', 'briefTitle': 'REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'Kiniksa Pharmaceuticals International, plc'}, 'officialTitle': 'Registry of the Natural History of Recurrent Pericarditis in Pediatric and Adult Patients', 'orgStudyIdInfo': {'id': 'KPL-914-Reg-001'}}, 'armsInterventionsModule': {'armGroups': [{'label': '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).'}, {'label': '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.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '99508', 'city': 'Anchorage', 'state': 'Alaska', 'country': 'United States', 'facility': 'Alaska Heart & Vascular Institute', 'geoPoint': {'lat': 61.21806, 'lon': -149.90028}}, {'zip': '85718', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Pima Heart and Vascular', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego Medical Center', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90048', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Cedars-Sinai Medical Center', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92037', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'Scripps Health', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52801', 'city': 'Davenport', 'state': 'Iowa', 'country': 'United States', 'facility': 'Midwest Cardiovascular Research Foundation', 'geoPoint': {'lat': 41.52364, 'lon': -90.57764}}, {'zip': '21218', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Massachusetts General Hospital', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02115', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': "Brigham and Women's Hospital", 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Detroit Medical Center', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '55407', 'city': 'Minneapolis', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Minneapolis Heart Institute Foundation', 'geoPoint': {'lat': 44.97997, 'lon': -93.26384}}, {'zip': '55905', 'city': 'Rochester', 'state': 'Minnesota', 'country': 'United States', 'facility': 'Mayo Clinic - PPDS', 'geoPoint': {'lat': 44.02163, 'lon': -92.4699}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Barnes-Jewish Hospital/Washington University', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '68198', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'University of Nebraska', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '07410', 'city': 'Fair Lawn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'TKL Research Inc.', 'geoPoint': {'lat': 40.94038, 'lon': -74.13181}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NYU Langone Health', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '10075', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Northwell Health - Lenox Hill Hospital', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '45219', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Linder Research Center at The Christ Hospital', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44106', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '97227', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Legacy Medical Group, Cardiology', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '15212', 'city': 'Pittsburgh', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Carnegie Mellon University, Allegheny Health Network, Allegheny General Hospital', 'geoPoint': {'lat': 40.44062, 'lon': -79.99589}}, {'zip': '75390', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Houston Methodist Hospital', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '84132', 'city': 'Salt Lake City', 'state': 'Utah', 'country': 'United States', 'facility': 'University of Utah', 'geoPoint': {'lat': 40.76078, 'lon': -111.89105}}, {'zip': '05405', 'city': 'Burlington', 'state': 'Vermont', 'country': 'United States', 'facility': 'University of Vermont Medical Center', 'geoPoint': {'lat': 44.47588, 'lon': -73.21207}}, {'zip': '23298', 'city': 'Richmond', 'state': 'Virginia', 'country': 'United States', 'facility': 'Virginia Commonwealth University', 'geoPoint': {'lat': 37.55376, 'lon': -77.46026}}, {'zip': '98105', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': "Seattle Children's Hospital", 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98122', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Medical Center - Cherry Hill', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'John F Paolini, MD, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Kiniksa Pharmaceuticals Corp'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kiniksa Pharmaceuticals International, plc', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Kiniksa Pharmaceuticals (UK), Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}