MedPath

Treatment of MuSK antibody-positive myasthenia gravis with rituximab: an exploratory clinical study

Not Applicable
Conditions
MuSK antibody-positive myasthenia gravis
Registration Number
JPRN-UMIN000012089
Lead Sponsor
Department of Neurology University of Tokyo, Graduate School of Medicine
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up complete
Sex
All
Target Recruitment
5
Inclusion Criteria

Not provided

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.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
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.
Secondary Outcome Measures
NameTimeMethod
© Copyright 2025. All Rights Reserved by MedPath