Effect of Rituximab in treatment of myasthenia gravis

Phase 2

Conditions: Myasthenia gravis.
Myasthenia gravis
G70.0

Registration Number: IRCT20190324043105N2

Lead Sponsor: Esfahan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Complete

Sex: All

Target Recruitment: 10

Inclusion Criteria

The patient has myasthenia gravis disease (positive AB test for AChR and MUSK *, evidence of myasthenia gravis disease in RNS test, positive Edrophonium test in the patient, and Chest MDCT for thymus involvement). * in Double Seronegative patients, both of these antibodies are negative; Therefore, the other 3 criteria used for diagnosis.
In the patients positive for Anti AchR or negative for both antibodies, these characteristics must present: resistance to corticosteroid therapy or is contraindication; resistance to azathioprine treatment or its side effects occur which necessitate the discontinuation of the drug.
In the patients positive for Anti MUSK, resistance to corticosteroid therapy or is contraindication, must occur.
The patient doesn't have Eaton Lambert syndrome.
The patient doesn't administrate unconventional medications (herbal, acupuncture, and etc.).
Desire of the patient to participate in this study and Signing Written Informed Consent.

Exclusion Criteria

Not provided

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Quality of patient's life. Timepoint: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. Method of measurement: MGQOL15.;Signs and symptoms of myasthenia gravis. Timepoint: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. Method of measurement: MG Composite Scale.;Post-intervention Status of the patients. Timepoint: after 6 and 12 months after the beginning of study. Method of measurement: MGFA Post-intervention Status.;Clinical status of the patients. Timepoint: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. Method of measurement: MGFA Clinical Classification Scale.;Amount of daily activities in myasthenia gravis patients. Timepoint: At the time of enrolling the patient to study, and then every 3 moths in the following period of 1 year. Method of measurement: MG-ADL scale.

Secondary Outcome Measures