Safety And Efficacy Of Tofacitinib In Patients With Refractory Myasthenia Gravis: A Pilot Study

Sponsor
Huashan Hospital
Study ID
NCT04431895
Phase
EARLY_PHASE1
Status
Completed

Conditions

  • Myasthenia Gravis, Generalized

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • Tofacitinib 5 MG — DRUG
    tofacitinib 5 mg tablet administered twice a day for 6 months

Study Details

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 treatment of tofacitinib followed by elution for one month.

Key Dates

Start date
Jun 11, 2020
Status verified
Sep 2022
Primary completion
Mar 21, 2024
Completion
Mar 31, 2024

Study Design

Enrollment
19 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: tofacitinib 5mg twice a day

Primary Outcome Measure

Change From Baseline in Quantitative Myasthenia Gravis (QMG) Scores at Month 6 [ Time Frame: Baseline, Month 6 ]

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