Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients
Condition: Neuromyelitis Optica Spectrum Disorder
MeSH terms: Neuromyelitis Optica
Study type: Interventional
Phase: Phase 2/Phase 3

Summary: 
      The purpose of this study is to compare annual relapse rate, expanded disability status
      scale, and side effects of azathioprine and rituximab in patients with neuromyelitis optica
      spectrum disorder during a one year follow up through a randomized clinical trial.
    

Detailed description: 
      Neuromyelitis Optica Spectrum Disorder (NMO-SD) is a recurrent inflammatory demyelinating
      disease affecting the central nervous system. The disease is clinically recognized by optic
      neuritis and transverse myelitis and is associated with high risk of mortality. Each attack
      worsens patients' disability. This means that after 5 years of the disease onset, half of
      patients need to use wheelchair and approximately 50% of them become blind.

      Considering that the disease can be disabling for patients, the maintenance treatment should
      be applied in addition to treatment of acute attacks, in order to prevent future recurrences.
      Acute attacks are usually treated with high doses of intravenous corticosteroids.
      Plasmapheresis is also used when patients fail to response to corticosteroids. B lymphocyte
      inhibitors are used as the maintenance therapy in these patients. First line therapeutic
      medications include azathioprine and rituximab which are being recommended for long term
      therapy and second line medications include methotrexate and mycophenolate mofetil.

      Azathioprine is an immune-modulatory agent which is available in the oral form and don't
      require hospitalization to be administered, however, because of side effects such as bone
      marrow suppression and hepatotoxicity, periodic check of blood cells and liver enzymes are
      needed. Rituximab is a cluster of differentiation antigen 20 inhibitor which leads to
      decreased B lymphocytes and antibody in patients. This medication is only available in the
      injectable form and needs hospitalization to be administered. Close monitory is needed during
      the administration considering severe side effects such as allergic reactions and respiratory
      distress. However, laboratory tests are not needed in patients taking rituximab although it
      is more expensive than azathioprine. No clinical trial has been performed previously to
      compare clinical efficacy of these two drugs in NMO-SD patients. Therefore, we aimed to
      compare their efficacy through a randomized clinical trial.
    

Intervention name(s): Azathioprine; Rituximab
Intervention type(s): Drug; Drug
Intervention description(s): Patients are started with Azathioprine 50 mg tablets, taken orally twice a day. The medication dose is increased gradually with the aim of lymphocytes count bellow 1500 and to the maximum dose of 3 g Azathioprine per day. Cell blood count is checked once a week in the first month of treatment, once every two weeks in the second month of treatment, and monthly in the third month of treatment to make decision about medication dose.; Patients will receive 1 g of Rituximab (two vials of RediTux 500 mg/50 ml) in 500 cc normal saline serum through intravenous infusion and this will be repeated two weeks later. This cycle will be repeated every 6 months.
Other intervention name(s): Azathioprine Mehrdaru®; RediTux®
Intervention MeSH terms: Rituximab; Azathioprine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: neuromyelitis optica spectrum disorder; azathioprine; rituximab; clinical trial; annual relapse rate; expanded disability status scale