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

• Status: Completed
• Trial end date: 2019-03-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2/Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Isfahan University of Medical Sciences
• Treatments: (T,G)-A-L; Chlorpheniramine; Glatiramer Acetate; Methylprednisolone; Rituximab

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