Myasthenia gravis. Myasthenia gravis and other myoneural disorders
Conditions
Interventions
The therapeutic process consists of two cycles. In cycle 1, Zytux™ 1000 mg (Aryogen-Pharmed Rituximab concentrated solution of 10mg/ml made for infusion) will be administered 2 times at day 0 and 15 a
Sponsors
AryoGen Pharmed Co.
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: Generalized Non-Thymothamous patients with myasthenia gravis patients including MuSK Antibody positive, AChR Antibody positive, and Seronegative myasthenia gravis patients. Not having previous treatment with rituximab. Refractory to standard treatment or contraindicated including Corticosteroid dependency (taking at least 2 months of 1mg/kg corticosteroid medications and has not responded properly, or being stable with steroid therapy, but during tapering down the medication up to 30 mg alternative or 15 mg daily, has experienced a relapse of the disease); Having contraindication of corticosteroid therapy; Not responder to Azathioprine (2-3 mg/kg) therapy for at least 9 months of taking the medication or because of occurrence of adverse effects of Azathioprine the medication has been stopped. Aged greater or equal to 18, and lesser or equal to 80.
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Changes in the mean dose of corticosteroid used by patients. Timepoint: day 0, day 15, week 12, week 24, week 36, week 48. Method of measurement: Patient’s concomitant medication. | — |
Secondary
| Measure | Time frame |
|---|---|
| Safety of Zytux™ (Rituximab) in refractory myasthenia gravis patients. Timepoint: day 0, day 15, week 12, week 24, week 36, week 48. Method of measurement: Physical Examination.;Time to relapse from the onset of treatment. Timepoint: day 0, day 15, week 12, week 24, week 36, week 48. Method of measurement: Physical Examination.;Changes in AChR and MuSK antibody levels. Timepoint: day 0 and week 48. Method of measurement: The Serum titer of AChR and MuSK antibodies.;Changes in the mean dose of pyridostigmine used by patients. Timepoint: day 0, day 15, week 12, week 24, week 36, week 48. Method of measurement: Patient’s concomitant drugs during treatment.;Changes in CD19 and CD20 levels. Timepoint: week 7, week 24. Method of measurement: Flow Cytometry. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNassim Anjidani
Orchid Pharmed Co.
Outcome results
None listed