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Clinical Trial Summary

This study is designed to evaluate the effectiveness and safety of tacrolimus combined with low-dose prednisone in the management of myasthenia gravis patients, compared to tacrolimus as initial immune monotherapy.


Clinical Trial Description

This is a single center, observational real-world study recruiting myasthenia gravis patients from Neurology Departments of Xuanwu Hospital, aiming to compare effectiveness and safety of 2 different inmunotherapy for MG. The study plans to recruit 160 MG participants and divides into 2 treatment groups according to physician's judgment and preferences of patients, one is combined immunotherapy group in which tacrolimus added with low-dose prednisone (0.25mg/kg/d), and the other is tacrolimus monotherapy group. Both groups can be treated with pyridostigmine to relieve symptoms. Patients are followed up at 1, 3 and 6 month after treatment initiation to assess the efficacy of both regimen. The primary outcome is the change of MG-ADL scores. Also, liver and renal functions are tested to monitor any side effects. Patients' clinical records are uploaded to an online database. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04768465
Study type Observational [Patient Registry]
Source Da, Yuwei, M.D.
Contact Yuwei Da, M.D.
Phone 00-86-010-83198493
Email dayuwei1000@163.com
Status Recruiting
Phase
Start date January 1, 2021
Completion date October 31, 2024

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