Efficacy and Safety of Low-dose Rituximab in the Treatment of Refractory Myasthenia Gravis

Sponsor
First Affiliated Hospital, Sun Yat-Sen University
Study ID
NCT05332587
Phase
PHASE3
Status
Unknown

Conditions

  • Refractory Myasthenia Gravis
  • Rituximab

Eligibility Criteria

Sex
ALL
Age
N/A - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Rituximab — DRUG
    The therapeutical schema is rituximab 100-200 mg/week for a total of 2-4 times

Study Details

This study is designed to evaluate the effectiveness and safety of low-dose rituximab in patients with refractory myasthenia gravis. The traditional treatment of MG is immunosuppressive therapy, usually beginning with corticosteroids. However, up to 70% of treated patients show an incomplete response, including 10 - 30% who are unresponsive. Corticosteroids and other immunosuppressive therapies presented also many side effects. The investigators propose to evaluate in a pilot, open, prospective, single central study, the interest of rituximab (RTX) in the treatment of patients with refractory MG. Fifty patients with refractory MG will be included in the study and divided into two stages: 14 patients in the first stage were followed up after using RTX according to the study protocol. The study will move into the second stage on if the number of effective cases is greater than 3, otherwise, the study will be discontinued (based on Simon's Optimal Two-stage Design). The remaining 36 patients were enrolled in the second stage. In the first and second stages, the treatment plan and follow-up plan were consistent. The therapeutical schema is rituximab 100-200 mg/week for a total of 2-4 times, followed by adequate organ function, laboratory parameters and assessment of MG after each injection and end of follow up for 24 weeks.

Key Dates

Start date
Aug 1, 2020
Status verified
Apr 2022
Primary completion
Jul 1, 2022
Completion
Jul 1, 2022

Study Design

Enrollment
50 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Rituximab Treated
    rituximab

Primary Outcome Measure

Time to reach MM-1, the proportion of drug remission. [ Time Frame: 27 weeks ]

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