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This randomized controlled, multi-center study will carry out to assess the efficacy of GB-0998 compared to plasmapheresis in the treatment of the generalized Myasthenia Gravis based on the changes in Quantitative Myasthenia Gravis score (QMG score) as primary endpoint, and in addition, to assess the safety of GB-0998
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GB-0998 (Intravenous immunoglobulin) | Biological |
|
| |
| Plasmapheresis |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in QMG score | at 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels | from beginning of the treatment through 4th week |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Masaharu Takamori, Director | Neurological Center Kanazawa-Nishi Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Nagasaki University | Nagasaki | Nagasaki | 852-8501 | Japan |
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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 |
|---|---|
| D016756 | Immunoglobulins, Intravenous |
| D010956 | Plasmapheresis |
| ID | Term |
|---|---|
| D007074 | Immunoglobulin G |
| D007132 | Immunoglobulin Isotypes |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| Procedure |
|
| 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 |
| D007162 |
| Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D001781 | Blood Component Removal |
| D013812 | Therapeutics |
| D016060 | Sorption Detoxification |
| D005112 | Extracorporeal Circulation |
| D013514 | Surgical Procedures, Operative |