Neuromyelitis Optica Clinical Trial
Official title:
Safety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 Trial
In neuromyelitis optica spectrum disorder (NMOSD),interleukin-6 (IL-6) may play an important
role in facilitating plasma cells to produce pathological aquaporin 4 (AQP4) autoantibody.
Inhibition of IL-6 signaling pathway by Tocilizumab (ACTEMRA®), a humanized monoclonal
antibody may have shown beneficial clinical effects in a few patients with NMOSD.
Larger scale clincial trials may be needed to observe its efficacy and safety. Here, by
choosing azathioprine, one of the most frequently used medication in case of relapses, the
investigators compare the safety and efficacy of tocilizumab in preventing NMOSD attacks.
The investigators primarily aim to observe the time to first relapse from initiation of
tocilizumab or azathioprine treatment. The proportion of participants who experience
relapse-free in one year follow-up will be compared.
The secondary outcomes are to determine: The safety profile of tocilizumab and azathioprine
in participants with NMO and whether tocilizumab improves visual function, Expanded
Disability Status Scale (EDSS), et al.
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