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Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders

NCT03350633 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 118

Last updated 2019-10-24

No results posted yet for this study

Summary

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.

Conditions

  • Neuromyelitis Optica Spectrum Disorders
  • Neuromyelitis Optica

Interventions

DRUG

Tocilizumab Injection

Tocilizumab Injection will be intravenously administered with a dose of 8 mg/kg every 4 weeks.

DRUG

Azathioprine

Azathioprine will be orally given at a dose of 2-3 mg/kg/d

Sponsors & Collaborators

  • Tianjin Medical University General Hospital

    lead OTHER

Principal Investigators

  • Fu-Dong Shi, MD,PhD · Tianjin Medical University General Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-11-01
Primary Completion
2019-09-01
Completion
2019-09-01

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03350633 on ClinicalTrials.gov