(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]
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.
Abatacept in Immune Checkpoint Inhibitor Myocarditis
Status: Recruiting
Location: "Beth Israel Deaconess Medical Center ", Allegheny-Singer Research Institution, Aurora St. Luke's Medical Center, Boston Medical Center, Brigham and Women's Hospital, Cedars-Sinai Medical Center, Cleveland Clinic, Columbia University Medical Center, Franciscan Health, Johns Hopkins University, Lehigh Valley Health Network, Los Angeles, MD Anderson Cancer Center, Maine Health, Massachusetts General Hospital, Mayo Clinic, Mayo Clinic in Rochester, MedStar Health Research Institute - Georgetown University, Memorial Sloan Kettering Cancer Center, Moffitt Cancer Center, Ontario, Robert Wood Johnson University Hospital, University of British Columbia, University of California Los Angeles, University of Chicago, University of Kansas Medical Center, University of Kentucky, University of Michigan, University of North Carolina Chapel Hill, University of Pennsylvania, University of Texas Southwestern, University of Utah, University of West Virginia
Conditions: "Beth Israel Deaconess Medical Center ", Allegheny-Singer Research Institution, Aurora St. Luke's Medical Center, Boston Medical Center, Brigham and Women's Hospital, Cedars-Sinai Medical Center, Cleveland Clinic, Columbia University Medical Center, Franciscan Health, Johns Hopkins University, Lehigh Valley Health Network, Los Angeles, MD Anderson Cancer Center, Maine Health, Massachusetts General Hospital, Mayo Clinic, Mayo Clinic in Rochester, MedStar Health Research Institute - Georgetown University, Memorial Sloan Kettering Cancer Center, Moffitt Cancer Center, Ontario, Robert Wood Johnson University Hospital, University of British Columbia, University of California Los Angeles, University of Chicago, University of Kansas Medical Center, University of Kentucky, University of Michigan, University of North Carolina Chapel Hill, University of Pennsylvania, University of Texas Southwestern, University of Utah, University of West Virginia
City/State:
Los Angeles, California
Kansas City, Kansas
Lexington, Kentucky
Boston, Massachusetts
Ann Arbor, Michigan
New York, New York
Chapel Hill, North Carolina
Bethlehem, Pennsylvania
Dallas, Texas
Houston, Texas
Salt Lake City, Utah
Washington D.C.
Tampa, Florida
Chicago, Illinois
Indianapolis, Indiana
Portland, Maine
Baltimore, Maryland
Rochester, Minnesota
New Brunswick, New Jersey
Cleveland, Ohio
Philadelphia, Pennsylvania
Pittsburgh, Pennsylvania
Morgantown, West Virginia
Milwaukee, Wisconsin
Vancouver, British Columbia, Canada
Hamilton, Ontario, Canada
Contact Information:
Hannah K Gilman, MS
6177261019
[email protected]
Brief Summary:
The primary aim is to test whether abatacept, as compared to placebo, is associated with a reduction in major adverse cardiac events (MACE) among participants hospitalized with myocarditis secondary to an immune checkpoint inhibitor (ICI). The primary outcome, MACE, is a composite of first occurrence of cardiovascular death, non-fatal sudden cardiac arrest, cardiogenic shock, significant ventricular arrythmias, significant bradyarrythmias, or incident heart failure.
Detailed Description:
This investigator-initiated randomized trial is being conducted to test whether abatacept, as compared to placebo, is associated with a reduction in MACE among participants who develop myocarditis after treatment with an ICI. Immune checkpoint inhibitors leverage the immune system to treat a wide variety of cancers. Myocarditis is an uncommon immune related adverse event (irAE) secondary to treatment with an ICI. The guideline recommended treatment for ICI myocarditis is cessation of the ICI and administration of corticosteroids. However, despite administration of corticosteroids, the rate of MACE with ICI myocarditis is high. Data from multiple independent international cohorts have shown that the rate of MACE with ICI myocarditis despite administration of corticosteroids ranges from 25-50%.For comparison, the rate of MACE with myocarditis unrelated to an ICI is <5%.
Abatacept is a selective co-stimulation modulator that inhibits T cell (T lymphocyte) activation by binding to CD80 and CD86, thereby blocking its interaction with CD28. This interaction provides a costimulatory signal necessary for full activation of T lymphocytes. In animal studies of ICI myocarditis, the administration of abatacept led to a reduction in cardiac immune activation and an increase in survival. In retrospective unpublished clinical data, the administration of abatacept to participants with ICI myocarditis on corticosteroids was associated with a reduction in risk of MACE. There are no prospective studies testing whether abatacept is effective among participants with ICI myocarditis. Therefore, the primary aim of this trial is to test in a randomized double-blind placebo-controlled study whether abatacept, administered concurrently with corticosteroids, is associated with a reduction in MACE among participants with recently diagnosed ICI myocarditis