Clinical trial · Observational
Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis
Effectiveness and Safety of Tacrolimus Combined With Low-dose Prednisone for Treatment of Myasthenia Gravis: A Real-world Study
NCT04768465CI-TRIAL-00050300unknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Myasthenia Gravis | — | UNRESOLVED | — |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Pyridostigmine, Prednisone, Tacrolimus | Drug | — | UNRESOLVED |
| Pyridostigmine, Tacrolimus | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- Combined Immunotherapy
- description
- MG patients are treated with tacrolimus combined with low-dose prednisone (0.25mg/kg/d). Symptomatic treatment like pyridostigmine bromide can be added to relieve symptoms (≤480mg/d).
- interventionNames
- Drug: Pyridostigmine, Prednisone, Tacrolimus
- label
- Tacrolimus monotherapy
- description
- MG patients are treated with tacrolimus as initial immune monotherapy. Symptomatic treatment like pyridostigmine bromide can be added to relieve symptoms (≤480mg/d).
- interventionNames
- Drug: Pyridostigmine, Tacrolimus
Primary outcomes (1)
- measure
- Change of MG-specific Activities of Daily Living scale (MG-ADL) from Baseline
- timeFrame
- Baseline, 1 month, 3 months, 6 months
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * 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: 1. positive clinical response to acetylcholinesterase inhibitor 2. positive AchR-Ab or MuSK-Ab testing 3. 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 Criteria: * 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
References
Publications (0)
Data not yet available
No reference posted for this study.