(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]
Cardiac Sarcoidosis Randomized Trial
Status: Recruiting
Location: Montefiore Medical Center, Ohio State University Medical Center, Tufts Medical Center, University of Michigan, University of Minnesota, University of Utah, Virginia Commonwealth University, Yale-New Haven Hospital
Conditions: Montefiore Medical Center, Ohio State University Medical Center, Tufts Medical Center, University of Michigan, University of Minnesota, University of Utah, Virginia Commonwealth University, Yale-New Haven Hospital
City/State:
New Haven, Connecticut
Boston, Massachusetts
Ann Arbor, Michigan
New York, New York
Columbus, Ohio
Pittsburgh, Pennsylvania
Salt Lake City, Utah
Richmond, Virginia
Contact Information:
David H Birnie, MD
613-696-7269
[email protected]
Janine Ryan, BAH, CCRP
613-696-7000 ext 17077
[email protected]
Prospective randomized controlled trial comparing low dose Prednisone(or Prednisolone)/Methotrexate combination to standard dose Prednisone(or Prednisolone) in patients diagnosed with acute active clinically manifest cardiac sarcoidosis and not yet treated.
The Investigators hypothesize that low dose Prednisone(or Prednisolone)/Methotrexate combination will be as effective as standard dose Prednisone(or Prednisolone), and result in significantly better quality of life and less toxicity than standard dose Prednisone(or Prednisolone).
Subjects meeting the study inclusion/exclusion criteria will be randomized equally to receive either:
Everywhere but Japan:
- Prednisone 0.5 mg kg/day for 6-months (MAX dose 30 mg per day) or
- Methotrexate 15-20 mg po, sc, or IM once a week for 6-months + Folic Acid 2 mg OD for 6 months + Prednisone 20 mg day for 1 month, then 10 mg OD for 1 month, then 5 mg OD for one month then STOP
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, MD Anderson Cancer Center, Maine Health, Massachusetts General Hospital, Mayo Clinic, MedStar Health Research Institute - Georgetown University, Memorial Sloan Kettering Cancer Center, Moffitt Cancer Center, Robert Wood Johnson University Hospital, 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, MD Anderson Cancer Center, Maine Health, Massachusetts General Hospital, Mayo Clinic, MedStar Health Research Institute - Georgetown University, Memorial Sloan Kettering Cancer Center, Moffitt Cancer Center, Robert Wood Johnson University Hospital, 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
Contact Information:
Hannah K Gilman, MS
6177261019
[email protected]
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