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Brief Title: Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis
Official Title: A Phase III, Open-label Extension Trial of tMG to Evaluate the Safety and Efficacy of Tocilizumab in Subjects With Generalized Myasthenia Gravis (gMG)
Study ID: NCT05716035
Brief Summary: To evaluate the safety and efficacy of tocilizumab in the treatment of generalized myasthenia gravis (gMG) as an extension study for the participants who previously completed Study tMG(NCT05067348).
Detailed Description: tMG-E was an extension study designed to provide the participants who completed Study tMG an opportunity to receive tocilizumab and collect clinical data to provide long-term safety and efficacy information on tocilizumab in participants with gMG. After receiving blinded study treatment (tocilizumab or placebo) in Study tMG for 16 weeks, participants were eligible to enroll in the tMG-E extension study. Participants were to enter Study tMG-E within 8 weeks after completing their Week 16 visit in Study tMG. Study tMG-E consisted of an Open-Label treatment Phase up to 16 weeks.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Beijing Tiantan Hospital, Capital Medical University, Beijing, Beijing, China
Xiangya Hospital Central South University, Changsha, Hunan, China
Tangdu Hospital, The Fourth Military Medical University, Xi'an, Shaanxi, China
Huashan Hospital, Shanghai, Shanghai, China
West China Hospital of Sichuan University, Chengdu, Sichuan, China
Tianjin medical university general hospital, Tianjin, Tianjin, China