Spots Global Cancer Trial Database for Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

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Trial Identification

Brief Title: Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

Official Title: A Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia Gravis

Study ID: NCT05067348

Conditions

Myasthenia Gravis, Generalized

Interventions

Tocilizumab Injectable Product

Study Description

Brief Summary: Randomized, double-blind, placebo-controlled, parallel-group study with optional open-label extension.

Detailed Description: This study is a randomized, double-blind, placebo-controlled study, to be conducted at 6 study sites. Approximately 64 subjects will be enrolled. Patients with MG who are positive for anti-AChR antibodies will be enrolled. Patients who do not have anti-AChR or anti-MuSK antibodies will not be enrolled. Patients with MGFA classification II, III, or IV disease, MG-ADL score ≥ 5, QMG score ≥ 11, and use of a corticosteroid and/or non-steroidal immunosuppressant will be included in the study. All subjects who complete the randomized controlled period will have the option to enroll in a 1-year open-label period.