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The safety and efficacy of tocilizumab in patients with neuromyelitis optica: Multicenter Study

Not Applicable
Conditions
neuromyelitis optica
Registration Number
JPRN-UMIN000007866
Lead Sponsor
Department of Immunology, National Institute of Neuroscience, NCNP
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
Complete: follow-up continuing
Sex
All
Target Recruitment
15
Inclusion Criteria

Not provided

Exclusion Criteria

1) Patients with severe infection such as tuberculosis, pneumocystis carinii pneumonia, nontuberculous mycobacterial infection, hepatitis B, hepatitis C, or chronic active EB virus infection. 2) Patients with a history of tuberculosis infection or patients with pleural thickness or old tuberculin in chest X-ray. 3) Patients with a history of hypersensitivity to this drug. 4) Patients with a history of intestinal diverticulum. 5) Patients with interstitial pneumonitis. 6) Patients with leukopenia (white blood cell number < 4000/mm3), lymphopenia (lymphocyte number < 1000/mm3) or seropositivity for beta-D-glucan in peripheral blood. 7) Pregnant women or patients with possible pregnancy. 8) Patients who can not provide consent to participate in this study by themselves. 9) Patients whose EDSS are more than 7.

Study & Design

Study Type
Interventional
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
-Adverse events up to 2 years -MRI lesion parameters, relapsing rate, and EDSS up to 2 years
Secondary Outcome Measures
NameTimeMethod
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