NCT02110706

BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 52 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 21 Years – 90 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Rituximab	Intervention (rituximab): The treatment group will receive a total of two cycles of rituximab separated by 6 months. Each cycle is defined as one infusion (375mg/m2 IV) per week for four consecutive weeks
DRUG	Placebo	The placebo group will receive a vehicle control infusion

Timeline

• Start date: 2014-05-01
• Primary completion: 2017-07-01
• Completion: 2018-05-01
• First posted: 2014-04-10
• Last updated: 2020-03-06
• Results posted: 2018-10-02

Locations

26 sites across 1 country: United States