]>
IRCT20190324043105N2 IRCT 2020-06-23 Esfahan University of Medical Sciences Effect of Rituximab in treatment of myasthenia gravis Treatment effect of Rituximab in myasthenia gravis patients resistant to the standard treatment 2019-01-01 anticipated 10 Complete https://irct.ir/trial/48614 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Other, Purpose: Treatment. 2-3 Myasthenia gravis. 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).. Yes - There is a plan to make this available What will be shared: after finishing this trial, MGFA Clinical Classification Scale, MG-ADL scale, MG Composite Scale, MGQOL15, and MGFA Post-intervention Status scores of all patients will be shared with all researchers. When: starting 6 months after publication To whom: The data will be availabe only to people working in academic institutions. Conditions: the deidentified individual participant data will be available only for research purposes. Where to obtain: alireza.eishi@yahoo.com How to obtain: by sending his/her request to mentioned Email, within less than a month: alireza.eishi@yahoo.com Comments:
public Mahshid Golagha
EMG Department, Alzahra University Hospital, Soffeh Blvd., Isfehan
Isfahan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 mahshidgolagha32@gmail.com Esfahan University of Medical Sciences scientific Keivan Basiri
EMG Department, Alzahra University Hospital, Soffeh Blvd., Isfehan
Isfehan Iran (Islamic Republic of) 8174675731 +98 31 3620 2020 basiri.keivan@gmail.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 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. 18 years 75 years Both G70.0 Myasthenia gravis Treatment - Drugs 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). 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. 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. Esfahan University of Medical Sciences Approved 2019-06-16 Ethical Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jarib Ave., Isfahan, Iran Isfehan Isfehan Iran (Islamic Republic of)