MuSK antibody-positive myasthenia gravis
Conditions
Interventions
Administration of Rituximab at the standard dose of 375 mg/m2 every week for 4 consecutive weeks and then monthly for the next 3 months.
Sponsors
Department of Neurology University of Tokyo, Graduate School of Medicine
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: (1) MuSK antigody-positive MG patients who did not attain remission with oral steroid and immunosuppressors, and need hospitalization for plasma pheresis or high-dose intravenous immunoglobulin. (2) The patients who are given information about this study and decide to undergo the study and express the consent in consent forms.
Exclusion criteria
Exclusion criteria: (1) Patients who have severe hypersensitivity or anaphylactic reaction to rituximab or mouse-derived products. (2) Pregnant women or women of possibility of pregnancy. (3) Lactating women. (4) Patients of HBs antigen positive or patients who had HBV infection in their past. (5) Patients of HBs antigen negative and HBc antibody or HBs antibody positive, and detectable HBV-DNA. (6) Patients who have received any other experimental drug or investigational product within three months before the start of study treatment in the present study. (7) Patients who are considered inadequate for this study by Principal investigator.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| We assess the clinical state of patients using a Myasthenia gravis foundation of America post-intervention status (MGFA-PIS), Quantitative MG score for Disease Severity (QMG score), and the amounts of waning of repetitive stimulation tests. A patient is considered to have responded if they have attained an MGFA-PIS of improved, Minimal Manifestations, Pharmacologic Remission or Complete Stable Remission. The effectiveness evaluation is established by the response rate. | — |
Countries
Japan
Contacts
Public ContactYasuo Terao
University of Tokyo Department of Neurology
Outcome results
None listed