NN103 Beat MG

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

Myasthenia gravis (MG) is an autoimmune disorder of neuromuscular transmission with an estimated annual incidence of about 1-2 per 100,000 and prevalence as high as 20-50 per 100,000.  Common symptoms include a drooping eyelid, double vision, slurred speech, difficulty chewing and swallowing, weakness in the arms and legs, chronic muscle fatigue, and difficulty breathing.  Despite current therapies a subset of patients remain medically refractory or have intolerable medication adverse effects. There is need for another agent in the management of MG as there are few effective drugs.  Safe, well-tolerated, effective and steroid-sparing therapeutics are very desirable.

The purpose of the study is to find out the effect and safety of a new use of the drug rituximab in myasthenia gravis (MG) patients who are on prednisone. NN103 Beat-MG is the first prospective, placebo-controlled trial exploring the role of B cell depletion therapy in MG. The results of this trial will not only add to our current understanding of this therapy strategy in MG, but also help further guide treatment paradigms in MG. This trial has recently completed enrollment and study activity, and topline results will soon be available.

NN103 is supported by NINDS (U01 NS084495) and the study intervention is provided by Genentech Pharmaceuticals.

Protocol Principal Investigator: 
Contact Information: 

For more information about participating, please contact: MGstudy@yale.edu, or call 1-844-MGSTUDY (647-8839)

CCC Project Managers: Safawa Huq, Andrea Ariza, Daniela Grasso

DCC Project Coordinator: Brenda Pearson

Publications: 
  • Nowak RJ, Coffey CS, Goldstein JM, Dimachkie MM, Benatar M, Kissel JT, Wolfe GI, Burns TM, Freimer ML, Nations S, Granit V, Smith AG, Richman DP, Ciafaloni E, Al-Lozi MT, Sams LA, Quan D, Ubogu E, Pearson B, Sharma A, Yankey JW, Uribe L, Shy M, Amato AA, Conwit R, O'Connor KC, Hafler DA, Cudkowicz ME, Barohn RJ; NeuroNEXT NN103 BeatMG Study Team. Phase 2 Trial of Rituximab in Acetylcholine Receptor Antibody-Positive Generalized Myasthenia Gravis: The BeatMG Study. Neurology2021 December 2doi: 10.1212/WNL.00000000.
    PubMed: PMID: 34857535