Clinical Trial: Comparison of Clinical Effects of Azathioprine and Rituximab NMO-SD Patients

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Comparison of Annual Relapse Rate, Expanded Disability Status Scale, and Side Effects Between Azathioprine and Rituximab in Patients With Neuromyelitis Optica Spectrum Disorders<

Brief 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 Summary:

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
Sponsor: Isfahan University of Medical Sciences

Current Primary Outcome: Annual Relapse Rate [ Time Frame: one year ]

annual relapse rate will be measured in the baseline (according to patients' history in the last year) and after 12 months of intervention.


Original Primary Outcome: Same as current

Current Secondary Outcome: Expanded Disability Status Scale [ Time Frame: one year ]

expanded disability status scale will be measured in the baseline and after 12 months of intervention


Original Secondary Outcome: Same as current

Information By: Isfahan University of Medical Sciences

Dates:
Date Received: December 21, 2016
Date Started: September 2015
Date Completion:
Last Updated: December 30, 2016
Last Verified: December 2016