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8201: Explore MG 2

Background

This natural history study under MGNet explores myasthenia gravis (MG), a rare autoimmune disease characterized by weakness of the voluntary muscles. MG has a prevalence of approximately 14–40 per 100,000 people in the United States. There is no cure for MG, however understanding the disease is crucial to pave the way for development of new therapies. Thus, Explore MG 2 proposes to accomplish comprehensive clinical phenotyping linked to bio-specimen collection to better understand disease characteristics and identify treatment predictive and responsive biomarkers. The study creates the infrastructure for clinical trial readiness to inform future MG clinical trials and patient care.

The overall research aims are:

  • Characterize the clinical phenotype, epidemiology, and diagnostic and management paradigms in the subgroups of MG
  • Enhance an existing multi-center biospecimen collection process to support MGNet clinical projects 2 and 3, MGNet pilot studies program, and the greater MG research community.

About this Study

Explore MG is projected to enroll and follow up a total of 400 subjects diagnosed with MG over the course of two years in 7 of MGNet institutions. The study is open to adults 18–99 years old with an anticipated gender distribution of approximately equal men and women. This study excludes children but future research is expected to include children. Study enrollment will occur over 4 years and each subject will be followed for a total of two years.

Targeted Enrollment: 400

To be eligible to participate, you must be:

  • Over the age of 18 years
  • Have an established diagnosis of myasthenia gravis as indicated:
    • Diagnosed with MG based on clinical manifestations and serum autoantibodies
      or
    • A decrement response on repetitive nerve stimulation
      or
    • A positive single-fiber electromyography (EMG) or positive edrophonium test
  • Able and willing to provide written informed consent

You are not eligible to participate if:

You have a serious medical illness that in the opinion of the investigator, is likely to interfere with completion of the study

How to participate:

In order to participate, please contact the study coordinator or principal investigator of any of the participating institutions by phone or by email. Please use the information to the right to inquire about participation.