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).
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
64
Participants will receive IV tocilizumab
Beijing Tiantan Hospital, Capital Medical University
Beijing, Beijing Municipality, China
NOT_YET_RECRUITINGXiangya Hospital Central South University
Changsha, Hunan, China
NOT_YET_RECRUITINGTangdu Hospital, The Fourth Military Medical University
Xi'an, Shaanxi, China
Incidence of treatment-emergent adverse events (TEAEs)
Time frame: From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks)
Change in Quantitative Myasthenia Gravis (QMG) scores.
Time frame: 16 weeks
Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks
Time frame: 16 weeks
Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks
Time frame: 16 weeks
Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score
Time frame: 16 weeks
Change in Myasthenia Gravis Composite (MGC) score
Time frame: 16 weeks
Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score.
Time frame: 16 weeks
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Huashan Hospital
Shanghai, Shanghai Municipality, China
RECRUITINGWest China Hospital of Sichuan University
Chengdu, Sichuan, China
NOT_YET_RECRUITINGTianjin medical university general hospital
Tianjin, Tianjin Municipality, China
RECRUITING