Clinical Trial: BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: B Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia Gravis

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 Summary:

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.

In order to assess safety in the B cell recovery during the repopulation period as well as the assess the long-term durability of response, there are two additional optional observational off study-intervention time points (weeks 72 and 96). The subjects will be treated per medical standard of care during this period.

The specific aim of this study is to determine whether rituximab is a safe and effective treatment for subjects with MG.


Sponsor: Yale University

Current Primary Outcome:

  • Percent of subjects that achieve a ≥ 75% reduction in mean daily prednisone dose in the 4 weeks prior to week 52 [ Time Frame: 4 weeks prior to week 52 ]
  • Frequency of Study-Related Adverse Events [ Time Frame: At the end of study-approximately 3 years ]


Original Primary Outcome: Same as current

Current Secondary Outcome:

Original Secondary Outcome:

Information By: Yale University

Dates:
Date Received: April 7, 2014
Date Started: May 2014
Date Completion: December 2017
Last Updated: March 1, 2017
Last Verified: July 2016