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IRCT20150303021315N18 IRCT 2020-05-23 AryoGen Pharmed Co. Evaluation of efficacy and safety of Zytux™ (Rituximab) in refractory myasthenia gravis patients Evaluation of efficacy and safety of Zytux™ (Rituximab) in refractory myasthenia gravis patients 2020-02-11 anticipated 30 Complete https://irct.ir/trial/47330 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 4 Myasthenia gravis. 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 and one single infusion (1000 mg) 6 months later in cycle 2. However, Zytux™ will be administered sooner if myasthenic symptoms reappear and interfere with the daily life activities of the patient (the interval between Zytux™ infusions should be at least three months).. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available.
public Nassim Anjidani
No 42, Attar St., Vanak Sq.
Tehran Iran (Islamic Republic of) 1994766411 009843473000 anjidani.n@orchipharmed.com Orchid Pharmed Co. scientific Dr. Farzad Fatehi
Shariati hospital, Cross Jalal Al Ahmad highway, North Karegar St.
Tehran Iran (Islamic Republic of) 1411713135 +98 21 8490 1000 fatehifa@gmail.com Tehran University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) Iran (Islamic Republic of) 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. 18 years 80 years Both 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 G70 Myasthenia gravis and other myoneural disorders Treatment - Drugs 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 and one single infusion (1000 mg) 6 months later in cycle 2. However, Zytux™ will be administered sooner if myasthenic symptoms reappear and interfere with the daily life activities of the patient (the interval between Zytux™ infusions should be at least three months). 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. 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. AryoGen Pharmed Co. Approved 2020-02-11 Ethics Committee of Tehran University of Medical Sciences No. 23, 16th Azar Ave., Keshavarz Blvd. Tehran Tehran Iran (Islamic Republic of)