Status:
UNKNOWN
Efficacy and Safety of Low-dose Rituximab in the Treatment of Refractory Myasthenia Gravis
Lead Sponsor:
First Affiliated Hospital, Sun Yat-Sen University
Conditions:
Refractory Myasthenia Gravis
Rituximab
Eligibility:
All Genders
Up to 80 years
Phase:
PHASE3
Brief Summary
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, usua...
Eligibility Criteria
Inclusion
- Aged 80 and under;
- Myasthenia gravis:
- Patients who are diagnosed as generalized or ocular myasthenia gravis
- Patients must have disease refractory to treatment: the condition did not improve (QMG score decreased by less than 3 points after treatment) or even deteriorated after treatment with sufficient prednisone or other immunosuppressive agents.
- Patients sign informed consent forms
Exclusion
- Over the age of 80
- Patients with serious complications such as infection
- Patients with active TB (during the screening period, a chest X-ray or chest CT would be performed unless the patient can provide chest X-ray or chest CT reports in the last month); or patients with active HBV, HBV DNA\> 200
- Patients suffering from cardiomyopathy, acute coronary events, or severe arrhythmia.
- Patients who were allergic to rituximab
- Pregnant or suckling period woman
- Patients accompanied with mental disorders and have difficult to communication
- Patients with a significant abnormality in white blood cells, hemoglobin, and platelet count.
Key Trial Info
Start Date :
August 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2022
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT05332587
Start Date
August 1 2020
End Date
July 1 2022
Last Update
May 2 2022
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
First Affiliated Hospital, Sun Yat-Sen University
Guangzhou, China, 510080