Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients

Treatment tested

• Rituximab

  B-lymphocyte antigen CD20 binding agent

• Glatiramer acetate

  Unknown

Other measures (3)

Inclusion Criteria: * age between 18 and 55 years old * diagnosis of active secondary progressive multiple sclerosis based on the latest McDonald criteria in 2010 * experiencing at least one relapse during the last year * expanded disability status scale ≤5 * diagnosis of secondary progressive MS for at least one year * maintaining pregnancy prevention methods for women in reproductive ages * filling the written informed consent prior to enrollment Exclusion Criteria: * diagnosis of other subtypes of MS, including relapsing-remitting MS and primary progressive MS and inactive form of the disease * experiencing relapse during the 30 days before starting the study * receiving systemic corticosteroid therapy during the last 30 days * undergoing plasmapheresis or receiving intravenous immunoglobulin during the last 1 months * history of other demyelinative diseases of central nervous system such as neuromyelitis optica spectrum disorders * history of other autoimmune diseases such as systemic lupus erythematosus, sjogren's syndrome, antiphospholipid syndrome, and behcet's disease * presence of chronic or recurrent infections such as hepatitis B, hepatitis C, or syphilis * pregnancy or lactation * receiving live attenuated viral vaccines during the last 4 weeks * history of cardiac arrhythmia, angina pectoris, or other cardiac diseases * history of immunodeficiency syndromes such as HIV * white blood cell count \<2500 or lymphocyte count \<400 * history of brain and spinal malignancies * history of severe allergic reactions or anaphylaxis to monoclonal antibodies * presence of active bacterial, viral, fungal, mycobacterial, or other infections * alcohol or drug abuse during the last two years * unable to undergo MRI * presence of uncontrolled cardiac, respiratory, renal, hepatic, endocrine, or gastrointestinal disease * presence of encephalopathy due to infectious (such as herpes, syphilis, ...) or metabolic (vitamin B12 deficiency) reasons * history of bone marrow transplant, whole body radiotherapy, or other treatments leading to reduction of lymphocytes * Cr>1.4 in women and >1.6 in men * aspartate transaminase and alanine transaminase 2.5 times higher than the normal amount * platelet count \<100000 * Hb \<8.5

The purpose of this study is to compare expanded disability status scale, annualized relapse rate, Gad-enhanced brain lesions, and side effects after administration of rituximab and glatiramer acetate among patients with active secondary progressive multiple sclerosis during a one year follow up through a randomized clinical trial.