drugset / Trial / NCT02110706
BeatMG: Phase II Trial of Rituximab In Myasthenia Gravis
Phase 2
Completed
52 enrolled
Yale University
National Institute of Neurological Disorders and Stroke (NINDS) · collab
RandomizedSingle-groupTriple-blindTreatment
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.
Timeline
- Start
- 2014-05
- Primary completion
- 2017-07
- Completion
- 2018-05
Outcome
Missed primary endpoint
paper the pre-defined clinically meaningful improvement of 30% due to rituximab over placebo was unlikely to be achieved PMID 34857535 ↗
paper rituximab is safe but unlikely to reduce steroid use by an absolute difference of at least 30% at 1 year. PMID 34857535 ↗
Publications
- Roy B, Chen J, Khani-Habibabadi F, McLaren N, Soliven BC, Juel VC, O'Connor KC, Nowak RJ, Kusner LL, Kaminski HJ. A Distinct Immunological Signature in Late-Onset Myasthenia Gravis: Insights from an Exploratory Proteomics Study. Ann Neurol. 2026 Jan;99(1):198-210. doi: 10.1002/ana.78017. Epub 2025 Sep 6.
- 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. Neurology. 2022 Jan 25;98(4):e376-e389. doi: 10.1212/WNL.0000000000013121.
- Di Stefano V, Lupica A, Rispoli MG, Di Muzio A, Brighina F, Rodolico C. Rituximab in AChR subtype of myasthenia gravis: systematic review. J Neurol Neurosurg Psychiatry. 2020 Apr;91(4):392-395. doi: 10.1136/jnnp-2019-322606. Epub 2020 Feb 25.
- Hehir MK, Hobson-Webb LD, Benatar M, Barnett C, Silvestri NJ, Howard JF Jr, Howard D, Visser A, Crum BA, Nowak R, Beekman R, Kumar A, Ruzhansky K, Chen IA, Pulley MT, LaBoy SM, Fellman MA, Greene SM, Pasnoor M, Burns TM. Rituximab as treatment for anti-MuSK myasthenia gravis: Multicenter blinded prospective review. Neurology. 2017 Sep 5;89(10):1069-1077. doi: 10.1212/WNL.0000000000004341. Epub 2017 Aug 11.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Rituximab | Monoclonal antibody | 375 mg/m2 | Intravenous |