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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| tocilizumab | Experimental | Participants will receive tocilizumab 8mg/Kg administered intravenously (IV) on weeks 1,5,9 and 13 of the open-lable period. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tocilizumab Injection | Drug | Participants will receive IV tocilizumab |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of treatment-emergent adverse events (TEAEs) | From Baseline (Day 1) to Safety Follow-Up Visit (up to 16 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quantitative Myasthenia Gravis (QMG) scores. | 16 weeks | |
| Proportion of subjects with both (1) ≥ 3-point improvement in QMG and (2) lasts ≥4 weeks | 16 weeks | |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Beijing Tiantan Hospital, Capital Medical University | Not yet recruiting | Beijing | Beijing Municipality | 100050 | China |
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| ID | Term |
|---|---|
| D009157 | Myasthenia Gravis |
| ID | Term |
|---|---|
| D020361 | Paraneoplastic Syndromes, Nervous System |
| D009423 | Nervous System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| C502936 | tocilizumab |
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| Proportion of subjects with both (1) ≥ 2-point improvement in MG-ADL and (2) lasts ≥4 weeks |
| 16 weeks |
| Change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) Profile score | 16 weeks |
| Change in Myasthenia Gravis Composite (MGC) score | 16 weeks |
| Change in Myasthenia Gravis Quality of Life-15, revised (MG-QOL15r) score. | 16 weeks |
| Xiangya Hospital Central South University | Not yet recruiting | Changsha | Hunan | 410008 | China |
|
| Tangdu Hospital, The Fourth Military Medical University | Recruiting | Xi'an | Shaanxi | 710038 | China |
|
| Huashan Hospital | Recruiting | Shanghai | Shanghai Municipality | 200040 | China |
|
| West China Hospital of Sichuan University | Not yet recruiting | Chengdu | Sichuan | 610041 | China |
|
| Tianjin medical university general hospital | Recruiting | Tianjin | Tianjin Municipality | 300052 | China |
|
| D010257 | Paraneoplastic Syndromes |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D019636 | Neurodegenerative Diseases |
| D020511 | Neuromuscular Junction Diseases |
| D009468 | Neuromuscular Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |