Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders

Sponsor
Tianjin Medical University General Hospital
Study ID
NCT03350633
Phase
PHASE2/PHASE3
Status
Completed

Conditions

  • Neuromyelitis Optica
  • Neuromyelitis Optica Spectrum Disorders

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Tocilizumab Injection — DRUG
    Tocilizumab Injection will be intravenously administered with a dose of 8 mg/kg every 4 weeks.
  • Azathioprine — DRUG
    Azathioprine will be orally given at a dose of 2-3 mg/kg/d

Study Details

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.

Key Dates

Start date
Nov 1, 2017
Status verified
Oct 2019
Primary completion
Sep 1, 2019
Completion
Sep 1, 2019

Study Design

Enrollment
118 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Tocilizumab
    Tocilizumab Injection (ACTEMRA®) , a IL-6 receptor blockade
  • Active Comparator: Azathioprine
    Imuran

Primary Outcome Measure

Time to first relapse [ Time Frame: From baseline to one year after ]

Related Studies