Status:
UNKNOWN
Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis
Lead Sponsor:
Da, Yuwei, M.D.
Conditions:
Myasthenia Gravis
Eligibility:
All Genders
18+ years
Brief 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 immun...
Detailed 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 i...
Eligibility Criteria
Inclusion
- Age ≥18
- Clinical Diagnosis of MG is confirmed based on typical clinical features of fluctuating muscle weakness, with at least 1 of the following supporting evidence:
- positive clinical response to acetylcholinesterase inhibitor
- positive AchR-Ab or MuSK-Ab testing
- decrement \>10% in repetitive nerve stimulations study (RNS) or increased jitter on single-fibre electromyography (SFEMG)
- MGFA clinical classification: I - IV
- Baseline MG-ADL ≥ 3
- Disease course from onset to enrollment ≤ 12 months
- Cooperation to followup
- Written informed consent
Exclusion
- Initiation of immunosuppressant for MG prior to screening, including Prednisone, Methylprednisolone, Azathioprine, Methotrexate, Cyclosporine A, Mycophenolate Mofetil, Tacrolimus and Cyclophosphamide
- Treatment of immunosuppressant for other concomitant disease 6 months prior to recruitment
- Rapid immunosuppressive treatments like Intravenous immunoglobulin or plasma exchange 1 month prior to recruitment
- Thymectomy within 3 months prior to Screening
- Concomitant chronic degenerative, psychiatric, or neurologic disorder that can cause weakness or fatigue
- Consciousness, dementia or schizophrenia
- Pregnancy or lactation, unwillingness to avoid pregnancy
- Uncontrolled hypertension or diabetes, Liver or kidney dysfunction, Cataract, Severe osteoporosis, Femoral head necrosis; Hyperkalemia, HIV, Acute or chronic infection
- Other conditions that would preclude participation
Key Trial Info
Start Date :
January 1 2021
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
October 31 2024
Estimated Enrollment :
160 Patients enrolled
Trial Details
Trial ID
NCT04768465
Start Date
January 1 2021
End Date
October 31 2024
Last Update
February 24 2021
Active Locations (1)
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1
Yuwei Da
Beijing, Beijing Municipality, China, 100053