Secondary Progressive Multiple Sclerosis Clinical Trial
Official title:
Comparison of Expanded Disability Status Scale, Gad-enhanced Brain Lesions, Annualized Relapse Rate, and Side Effects Between Active Secondary Progressive Multiple Sclerosis Patients on Rituximab and Glatiramer Acetate
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.
Multiple sclerosis (MS) is an autoimmune inflammatory demyelinative disease of central
nervous system. Active secondary progressive MS means progressive accumulation of disability
after an initial relapsing course which is also associated with clinical relapses and/or
new/enlarged Gad-enhanced brain lesions. This form of the disease leads to high rates of
morbidity and mortality among patients. Different immunosuppressive and immunomodulatory
agents are recommended by researchers to decrease relapses and improve disability among MS
patients. The effect of these medications on different phenotypes of MS are mostly
investigated solely and very small number of comparative studies are conducted to evaluate
the superiority of these medications on each other.
Glatiramer acetate is one of the known MS medications which is being used to control relapses
from a long time ago and different clinical trials have shown its partial efficacy among MS
patients. On the other hand, rituximab is one of the medications which is recently suggested
for treatment of MS and currently phase II clinical trials are conducted to evaluate the
efficacy of this medication among patients. As previously stated, there is a lack of clinical
trials to compare the efficacy of suggested medications among secondary progressive patients.
To fill this gap, we aimed to compare the efficacy of these two medications on disability,
annualized relapse rate, and Gad-enhanced brain lesions among patients with active secondary
progressive MS through a randomized clinical trial during a one-year follow-up period.
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