(281) 713-2962
800 Rockmead Drive, Suite 155
Kingwood, TX 77339
[email protected]
Risk Indicators of Sarcoidosis Evolution-Unified Protocol (RISE-UP)
Status: Recruiting
Location: University of Maryland, University of Texas Southwestern
Conditions: University of Maryland, University of Texas Southwestern
City/State:
Baltimore, Maryland
Dallas, Texas
Contact Information:
Laura Koth
4155144369
[email protected]
Jessica Cardenas
[email protected]
Brief Summary:
The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and blood markers that can be obtained during a clinic visit.
Detailed Description:
The purpose of this study is to develop prediction models that can prognosticate patients with sarcoidosis using clinical data and biological markers that can be obtained during a clinic visit.
Primary Aim/Objective The primary objective of this study is to determine which clinical features measured during a routine clinic visit are risk factors for progression of pulmonary sarcoidosis over the follow-up period in adults with pulmonary sarcoidosis.
Secondary Aim/Objectives The secondary objective is to determine if blood biomarkers measured during a routine clinic visit can improve the risk assessment for progression of pulmonary sarcoidosis over the follow-up period.
The investigators will measure two types of blood markers to achieve this goal:
- Clinically available blood markers that are available in most clinical labs
- Blood proteins and gene expression that reflect interferon inflammation and are not currently available as tests in clinical labs
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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]
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