A Phase III, Open-label Extension Trial of tMG to Evaluate the Safety and Efficacy of Tocilizumab in Subjects With Generalized Myasthenia Gravis (gMG)
Status: Recruiting
Location: See all (6) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2/Phase 3
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).
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:
• Participant has completed Study tMG.
• Participant has given written informed consent.
• MG-ADL score ≥ 5 points, or a decrease of ≤ 3 points relative to the baseline MG-ADL of the tMG study
Locations
Other Locations
China
Beijing Tiantan Hospital, Capital Medical University
NOT_YET_RECRUITING
Beijing
Xiangya Hospital Central South University
NOT_YET_RECRUITING
Changsha
West China Hospital of Sichuan University
NOT_YET_RECRUITING
Chengdu
Huashan Hospital
RECRUITING
Shanghai
Tianjin medical university general hospital
RECRUITING
Tianjin
Tangdu Hospital, The Fourth Military Medical University
RECRUITING
Xi'an
Time Frame
Start Date: 2023-04-01
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 64
Treatments
Experimental: tocilizumab
Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period.
Related Therapeutic Areas
Sponsors
Leads: Tang-Du Hospital