Spots Global Cancer Trial Database for BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis
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Trial Identification
Brief Title: BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis
Official Title: B Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia Gravis
Study ID: NCT02110706
Conditions
Study Description
Brief Summary: The specific primary objective of this study is to determine whether rituximab is a safe and beneficial therapeutic for Myasthenia Gravis (MG) that warrants further study in a phase III efficacy trial.
Detailed Description: Investigators plan on conducting a multicenter randomized, double-blind, placebo controlled Phase II clinical trial utilizing a futility design. The study would include acetylcholine receptor (AChR) antibody positive generalized MG subjects. This study also presents a unique opportunity to study both drug and disease mechanisms because unlike many other autoimmune diseases in which rituximab has been used, MG affords the investigation of antigen-specific components that participate in the immunopathology of the disease, namely autoantibodies, autoantibody-producing B cells, and antigen-specific T cells. This work will further our understanding of MG immunopathology and it represents the first step toward gaining a more complete understanding of the immune mechanisms underlying treatment of MG with rituximab leading to new ways to treat the disease. The specific aim of this study is to determine whether rituximab is a safe and effective treatment for subjects with MG. The SNOMED code for MG is 31839002.
Eligibility
Minimum Age: 21 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
University of California - Davis, Davis, California, United States
University of California - Los Angeles, Los Angeles, California, United States
University of Colorado - Denver, Denver, Colorado, United States
Yale School of Medicine, Department of Neurology, New Haven, Connecticut, United States
University of Miami School of Medicine, Miami, Florida, United States
Emory University, Atlanta, Georgia, United States
Northwestern University, Evanston, Illinois, United States
University of Kansas Medical Center, Kansas City, Kansas, United States
Brigham & Women's Hospital, Boston, Massachusetts, United States
Washington University, Saint Louis, Missouri, United States
Montefiore Medical Center, Bronx, New York, United States
SUNY Downstate Medical Center, Brooklyn, New York, United States
SUNY Buffalo, Buffalo, New York, United States
Columbia University Medical Center, New York, New York, United States
Weill Cornell Medical Center, New York, New York, United States
University of Rochester, Rochester, New York, United States
SUNY Stony Brook, Stony Brook, New York, United States
University of Cincinnati, Cincinnati, Ohio, United States
Ohio State University, Columbus, Ohio, United States
Oregon Health and Science University, Portland, Oregon, United States
University of Pittsburgh, Pittsburgh, Pennsylvania, United States
University of Texas Southwestern Medical Center, Dallas, Texas, United States
University of Utah, Salt Lake City, Utah, United States
University of Virginia, Charlottesville, Virginia, United States
Swedish Medical Center, Seattle, Washington, United States
Contact Details
Name: Richard J Nowak, MD, MS
Affiliation: Yale University
Role: PRINCIPAL_INVESTIGATOR
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