Efficacy and Safety Study of GB-0998 for Treatment of Generalized Myasthenia Gravis

Study Overview
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Brief Summary
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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

Official Title
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A Randomized, Controlled Clinical Study of GB-0998 for Treatment of Generalized Myasthenia Gravis

Conditions
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Generalized Myasthenia Gravis

Intervention / Treatment
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* Biological: GB-0998 (Intravenous immunoglobulin)
* Procedure: Plasmapheresis


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients diagnosed as generalized myasthenia gravis Patients who are not controlled by current therapy and need plasmapheresis therapy Patients who have the high-dose steroid therapy for over a month in past years, and also who take steroid or immunosuppressant on the day of consent Patients who had not any dose increase or new dosing of steroid or immunosuppressant within 4 weeks prior to enrollment Exclusion Criteria: Patients who received steroid pulse therapy, globulin therapy or plasmapheresis therapy within 12 weeks prior to enrollment Patients who had undergone thymectomy within 24 weeks prior to enrollment Patients with 3 points item in bulbar symptom of MG-ADL scale Patients with severe hepatic disorder, severe renal disorder or severe heat disorder Patients who have received treatment of malignant tumors Patients who have the anamnesis of shock or hypersensitivity to this drug Patients who have been diagnosed as hereditary fructose intolerance Patients who have the anamnesis of cerebral infarction or symptom of these diseases Patients who have been diagnosed as IgA deficiency in their past history Pregnant, lactating, and probably pregnant patients, and patients who want to become pregnant Patients who were administered other investigational drug within 12 weeks before consent

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: GB-0998 (Intravenous immunoglobulin)<br> <br> * Other names: Venoglobulin-IH;|
| Active Comparator: 2<br> | Procedure: Plasmapheresis<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in QMG score |  | at 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels |  | from beginning of the treatment through 4th week | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Myasthenia Gravis