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Effect of Rituximab in treatment of myasthenia gravis

Treatment effect of Rituximab in myasthenia gravis patients resistant to the standard treatment

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
IRCT
Registry ID
IRCT20190324043105N2
Enrollment
10
Registered
2020-06-23
Start date
2019-01-01
Completion date
Unknown
Last updated
2020-07-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Myasthenia gravis. Myasthenia gravis

Interventions

Intervention group: Rituximab
Patients will be treated with rituximab. It will be given as one gram in the first week, one gram in the third week, and then one gram in the sixth month intravenousy (in normal saline solution)..

Sponsors

Esfahan University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

Exclusion criteria:

Design outcomes

Primary

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactMahshid Golagha

Esfahan University of Medical Sciences

mahshidgolagha32@gmail.com+98 31 3620 2020

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026