Evaluation of efficacy and safety of Zytux™ (Rituximab) in refractory myasthenia gravis patients

Phase 4

Recruiting

• Conditions: Myasthenia gravis.; Myasthenia gravis and other myoneural disorders

• Registration Number: IRCT20150303021315N18
• Lead Sponsor: AryoGen Pharmed Co.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 15 June 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

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

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.