Trials / Completed
CompletedNCT03350633
Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders
Safety and Efficacy of Tocilizumab Versus Azathioprine in Neuromyelitis Optica Spectrum Disorders: a Randomized, Controlled, Open-label, Phase 2 Trial
- Status
- Completed
- Phase
- Phase 2 / Phase 3
- Study type
- Interventional
- Enrollment
- 118 (actual)
- Sponsor
- Tianjin Medical University General Hospital · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Detailed description
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2017-11-01
- Primary completion
- 2019-09-01
- Completion
- 2019-09-01
- First posted
- 2017-11-22
- Last updated
- 2019-10-24
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT03350633. Inclusion in this directory is not an endorsement.