Status:
COMPLETED
Tocilizumab vs Azathioprine in Neuromyelitis Optica Spectrum Disorders
Lead Sponsor:
Tianjin Medical University General Hospital
Conditions:
Neuromyelitis Optica Spectrum Disorders
Neuromyelitis Optica
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief 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...
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 fo...
Eligibility Criteria
Inclusion
- Male or female patients ≥ 18 years old
- Diagnosis of NMO or NMO spectrum disorder
- Clinical evidence of at least 2 relapses in last 12 months or 3 relapses in the last 24 months
- Able and willing to give written informed consent and comply with the requirements of the study protocol.
- EDSS \<= 7.5 (8 in special circumstances)
- Men and women of reproductive potential must agree to use a highly effective method of birth control from screening to 6 months after final dose of the investigational product.
Exclusion
- Current evidence or known history of clinically significant infection (Herpes simplex virus, varicella-zoster virus, cytomegalovirus, Epstein-Barr virus,human immunodeficiency virus, Hepatitis viruses, Syphilis, etc)
- Pregnant, breastfeeding, or child-bearing potential during the course of the study
- Patients will not participate in any other clinical therapeutic study or will not have participated in any other experimental treatment study within 30 days of screening
- Participation in another interventional trial within the last 3 months
- Heart or kidney insufficiency
- Tumor disease currently or within last 5 years
- Clinically relevant liver, kidney or bone marrow function disorder
- Intolerance of azathioprine or previous relapses on azathioprine treatment
- Receipt of rituximab or any experimental B-cell depleting agent within 6 months prior screening and B-cells below the lower limit of normal.
Key Trial Info
Start Date :
November 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 1 2019
Estimated Enrollment :
118 Patients enrolled
Trial Details
Trial ID
NCT03350633
Start Date
November 1 2017
End Date
September 1 2019
Last Update
October 24 2019
Active Locations (1)
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1
Tianjin Medical University General Hospital
Tianjin, Tianjin Municipality, China, 300052