Open-Label Extension of Tocilizumab in Subjects With Generalized Myasthenia Gravis

Sponsor
Tang-Du Hospital
Study ID
NCT05716035
Phase
PHASE2/PHASE3
Status
Unknown

Conditions

  • Myasthenia Gravis, Generalized

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Apr 1, 2023
Status verified
Jan 2024
Primary completion
Jul 31, 2024
Completion
Dec 31, 2024

Study Design

Enrollment
64 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: tocilizumab
    Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks) ]

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