Generalized Myasthenia Gravis
Conditions
Keywords
Myasthenia Gravis
Brief summary
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
Interventions
BIOLOGICALGB-0998 (Intravenous immunoglobulin)
PROCEDUREPlasmapheresis
Sponsors
Benesis Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
16 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in QMG score | at 4 weeks |
Secondary
| Measure | Time frame |
|---|---|
| Changes of QMG score, MG-ADL scale, anti-acetylcholine receptor antibody levels | from beginning of the treatment through 4th week |
Countries
Japan
Outcome results
None listed