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CardiolRx in Recurrent Pericarditis Following IL-1 Blocker Cessation (MAVERIC)
Status: Recruiting
Location: Cleveland Clinic, Columbia University Medical Center, Massachusetts General Hospital, Mayo Clinic in Rochester, Northwestern University Medicine, University of Vermont Medical Center, University of Virginia
Conditions: Cleveland Clinic, Columbia University Medical Center, Massachusetts General Hospital, Mayo Clinic in Rochester, Northwestern University Medicine, University of Vermont Medical Center, University of Virginia
City/State:
Chicago, Illinois
Boston, Massachusetts
Rochester, Minnesota
Cleveland, Ohio
Charlottesville, Virginia
New York, New York
Burlington, Vermont
Contact Information:
Name: Andrea B Parker, MSc., PhD
Phone Number: +1 289 910 0862
Email: [email protected]
Name: Heather Dalgleish, MSc.
Phone Number:+1 289 910 0384
Email: [email protected]
Brief Summary: Multi-center, randomized, double-blind, placebo-controlled, phase-3 Trial. Patients with a history of recurrent pericarditis who are being treated with an IL-1 blocker for at least 12 months, scheduled to be discontinued, will be approached for potential trial participation.
Double-blind treatment will be initiated 10 – 14 days prior to the last scheduled dose of the IL-1 blocker and continued for 24 weeks.
The objective is to assess whether patients who discontinue therapy with an IL-1 blocker for recurrent pericarditis remain free of pericarditis recurrence while receiving CardiolRx.
Detailed Description: Double-blind, randomised, placebo-controlled Phase-3 trial. The primary objective is to assess whether patients with IL-1 blocker-dependent recurrent pericarditis can discontinue IL-1 blocker therapy and remain free of recurrence while receiving CardiolRx.
After informed consent is obtained, patients will be screened for eligibility. Baseline assessments will be performed during screening within 7 days of Day 1 (Visit 1) and include the following: Physical examination, vital signs, highest NRS pain score within the past 7 days of Day 1, 12-lead ECG; hematology (CBC with differential) and blood chemistry (including complete metabolic panel: sodium, potassium, calcium, glucose, ALT/AST, bilirubin, alkaline phosphatase, blood urea nitrogen (BUN), creatinine/eGFR), C-SSRS and a pregnancy test for women of childbearing potential.
Eligible patients will be randomized on Day 1 to either CardiolRx or matching placebo. Double-blind trial therapy will be initiated in the evening of Day 1, 10 – 14 days prior to the last scheduled dose of the IL-1 blocker and after all baseline assessments are completed. Trial therapy will be administered for 24 weeks.
Final efficacy assessments will take place 24 weeks after starting trial therapy and include a physical exam, vital signs, pain score NRS, a 12-lead ECG, as well as laboratory assessments (including a pregnancy test in women of childbearing potential) and a C-SSRS.
A safety follow-up visit will be scheduled 4 weeks after the last trial therapy administration.
REgiStry Of the NAtural History of recurreNt periCarditis in pEdiatric and Adult Patients (Resonance)
Status: Active not recruiting
Location: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cedars-Sinai Medical Center, Children's National Hospital- Washington D.C., Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Detroit Medical Center, Houston Methodist Hospital, Johns Hopkins University, Lender Research Center at the Christ Hospital, Massachusetts General Hospital, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Northwestern University Medicine, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, Swedish Medical Center - Cherry Hill, TKL Research Inc., University of California - San Diego, University of Texas Southwestern, University of Utah, University of Vermont Medical Center, Virginia Commonwealth University
Conditions: Alaska Heart & Vascular Institute, Barnes-Jewish Hospital/Washington University, Brigham and Women's Hospital, Carnegie Mellon University, Cedars-Sinai Medical Center, Children's National Hospital- Washington D.C., Cincinnati Children's Hospital Medical Center, Cleveland Clinic, Detroit Medical Center, Houston Methodist Hospital, Johns Hopkins University, Lender Research Center at the Christ Hospital, Massachusetts General Hospital, Mayo Clinic in Rochester, Midwest Cardiovascular Research Foundation, Minneapolis Heart Institute Foundation, NYU Langone Health, Northwell Health - Lenox Hill Hospital, Northwestern University Medicine, Pima Heart and Vascular, Scripps Health, Seattle Children's Hospital, Swedish Medical Center - Cherry Hill, TKL Research Inc., University of California - San Diego, University of Texas Southwestern, University of Utah, University of Vermont Medical Center, Virginia Commonwealth University
City/State:
Anchorage, Alaska
Tucson, Arizona
La Jolla, California
San Diego
Davenport, Iowa
Baltimore, Maryland
Boston, Massachusetts
Minneapolis, Minnesota
Rochester, Minnesota
Saint Louis, Missouri
Fair Lawn, New Jersey
New York, New York
Cincinnati, Ohio
Cleveland, Ohio
Pittsburgh, Pennsylvania
Houston, Texas
Burlington, Vermont
Richmond, Virginia
Seattle, Washington
Los Angeles, California
Washington, D.C.
Chicago, Illinois
Detroit, Michigan
Dallas, Texas
Salt Lake City, Utah
Contact Information:
Study Director:John F Paolini, MD, PhD,Kiniksa Pharmaceuticals Corp
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.