Comparison of Clinical Effects of Rituximab and Glatiramer Acetate in Secondary Progressive Multiple Sclerosis Patients
Condition: Secondary Progressive Multiple Sclerosis
MeSH terms: Neoplasm Metastasis; Multiple Sclerosis; Multiple Sclerosis, Chronic Progressive; Sclerosis
Study type: Interventional
Phase: Phase 2/Phase 3

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.
    

Detailed description: 
      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.
    

Intervention name(s): Rituximab; Glatiramer Acetate
Intervention type(s): Drug; Drug
Intervention description(s): Patients will receive 1 g of rituximab (two vials of Zytux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion as one treatment cycle. This cycle will be repeated every 6 months. Along with rituximab, patients will receive 100 mg of methylprednisolone, 10 mg of chlorpheniramine, and 500 mg of acetaminophen. Before each cycle, patients will be evaluated regarding complete blood count (CBC)-diff, blood urea nitrogen (BUN), Cr, and liver function tests.; Patients will receive 40 mg of glatiramer acetate three times per week through subcutaneous injection. Patients will undergo electrocardiography before starting the treatment to find any abnormal finding. Also, lab tests will be checked for them prior to the treatment, including CBC-diff, BUN, Cr, and liver function tests.
Other intervention name(s): Zytux®; Osvimer®
Intervention MeSH terms: Rituximab; Glatiramer Acetate; (T,G)-A-L
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Active secondary progressive Multiple Sclerosis; Glatiramer acetate; Rituximab; Comparative study; Disability; Randomized clinical trial; Annualized relapse rate