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Study aim
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Evaluation of efficacy and safety of Zytux™ (Rituximab) in refractory myasthenia gravis patients
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Design
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This phase 4 prospective, single-arm, open-label, pre-post clinical trial study will be conducted in 30 patients with refractory myasthenia gravis.
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Settings and conduct
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This multi-center study will be conducted in patients with refractory myasthenia gravis in six different cities of Iran with a follow-up duration of 48 weeks. Zytux™ (Rituximab) will be administered to the eligible patients 2 times at day 0 and 15, followed by one single injection 6 months later. The outcomes will be assessed and recorded by a physician through 48 weeks of monitoring of the patients.
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Participants/Inclusion and exclusion criteria
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Inclusion criteria: Generalized Non-Thymothamous myasthenia gravis patients, Not having previous treatment with rituximab, Refractory to standard treatment or contraindicated including corticosteroid or Azathioprine, Age between 18 and 80 years
Exclusion criteria: Pregnancy, Planning for pregnancy in the following year, Lactation, Active infection, HBsAg+ OR HBV DNA Positive, Prior malignancy, Hypersensitivity reactions or anaphylactic shock to rituximab, Major renal disease, Major Hepatic disease, Cardiac Arrhythmia history, Occular myasthenia gravis, Thymomathous myasthenia gravis, Major Psychiatric disease, Doing Thymectomy
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Intervention groups
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The therapeutic schema is rituximab 1000 mg, 2 times at day 0 and 15, followed by one single injection (1000 mg) 6 months later. However, rituximab infusion will be administered sooner if myasthenic symptoms reappear and interfere with daily life activities of patient (the interval between Rituximab infusions should be at least three months).
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Main outcome variables
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Changes in the mean dose of corticosteroid used by patients