A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia Gravis

Summary

A randomized, double-blind, placebo-controlled multicenter study evaluating the safety and efficacy of Rituximab (Mabthera®) in patients with new onset generalized myasthenia gravis (MG).

Timeline

Start

2016-10-16

Primary completion

2021-01-30

Completion

2022-01-31

Outcome

Met primary endpoint

registry analysis (superiority test); Rituximab vs Sodium Chloride Solution; p = 0.007; probability ratio 2.48 (95% CI 1.20 to 5.11); Fisher Exact NCT02950155 ↗

Publications

• Piehl F, Eriksson-Dufva A, Budzianowska A, Feresiadou A, Hansson W, Hietala MA, Hakansson I, Johansson R, Jons D, Kmezic I, Lindberg C, Lindh J, Lundin F, Nygren I, Punga AR, Press R, Samuelsson K, Sundstrom P, Wickberg O, Brauner S, Frisell T. Efficacy and Safety of Rituximab for New-Onset Generalized Myasthenia Gravis: The RINOMAX Randomized Clinical Trial. JAMA Neurol. 2022 Nov 1;79(11):1105-1112. doi: 10.1001/jamaneurol.2022.2887.

Drugs

Indications