Status:
COMPLETED
Safety And Efficacy Of Tofacitinib In Patients With Refractory Myasthenia Gravis: A Pilot Study
Lead Sponsor:
Huashan Hospital
Conditions:
Myasthenia Gravis, Generalized
Eligibility:
All Genders
18-70 years
Phase:
EARLY_PHASE1
Brief Summary
This is a 6 month study that will evaluate the efficacy of 5mg tofacitinib tablet taken twice a day in patients with refractory myasthenia gravis. Twenty adult participants will receive a four month t...
Eligibility Criteria
Inclusion
- fluctuating muscle weakness and fatigability classified as the Myasthenia Gravis Foundation of America (MGFA) clinical classification Type IIa-IVa;
- more than 10% amplitude decrement in low frequency repetitive nerve stimulation, and less than 10% amplitude increment in high frequency repetitive nerve stimulation;
- understanding and assigning the informed consent form, and having a good compliance with treatment.
- meet all of the criteria in above as well as at least one of the below:
- refractory: insufficient response to full dose- and course- steroids treatment (0.75-1mg per kg per day for at least 3-6 months), failure to respond adequately to tacrolimus (no less than 3mg per day) for 3 months;
- severe or intolerable adverse effects from conventional immunosuppressive therapy.
Exclusion
- positive for muscle-specific kinase (MuSK) antibodies;
- a tumor history except for thymoma;
- a history of Type B and Type C hepatitis;
- a history of tuberculosis or T-SPOT.TB tset positivity;
- hepatic, renal and cardial insufficiency (baseline: ALT/AST\>50U/L;BNP\>200pg/ml）;
- severe allergy or infection, or chronic or recurrent infection;
- pregnancy;
- hyperlipidemia;
- participating other clinical trials
Key Trial Info
Start Date :
June 11 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2024
Estimated Enrollment :
19 Patients enrolled
Trial Details
Trial ID
NCT04431895
Start Date
June 11 2020
End Date
March 31 2024
Last Update
September 16 2025
Active Locations (1)
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1
Huashan Hospital
Shanghai, China, 200040