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Spots Global Cancer Trial Database for Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis

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Trial Identification

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

Study Description

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.

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Useful links and downloads for this trial

Clinicaltrials.gov

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