Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients
Secondary Progressive Multiple Sclerosis
About this trial
This is an interventional treatment trial for Secondary Progressive Multiple Sclerosis focused on measuring Active secondary progressive Multiple Sclerosis, Glatiramer acetate, Rituximab, Comparative study, Disability, Randomized clinical trial, Annualized relapse rate
Eligibility Criteria
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
Sites / Locations
- Kashani Hospital
Arms of the Study
Arm 1
Arm 2
Experimental
Experimental
Rituximab
Glatiramer acetate
Patients in this group will receive 1g of rituximab in 500 cc normal saline serum through intravenous infusion as one treatment course. The treatment course will be repeated in 6 months. Along with rituximab, 100 mg methylprednisolone, 10 mg chlorpheniramine, and 500 mg acetaminophen will also be injected to decrease side effects of rituximab.
Patients in this group will receive 40 mg of glatiramer acetate three times per week through subcutaneous injection.